Feasibility and Effectiveness of a Biography-Based Physical Activity Intervention in Institutionalized People With Dementia: Quantitative and Qualitative Results From a Randomized Controlled Trial

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The objective of this multicenter randomized controlled trial was to evaluate the feasibility and effectiveness of a physical activity intervention for institutionalized people with dementia, individualized by capacity and biography. The intervention group (n = 34; age: mean = 86.09 years; 79.40% female; mean Mini-Mental State Examination value = 18.59) participated in a multicomponent training program, which included daily activities, dancing, gardening, and sports/games, twice weekly for 3 months. The control group (n = 29; age: mean = 86.34 years; 75.90% female; mean Mini-Mental State Examination value = 19.90) received standard care. Feasibility was evaluated by means of focus groups and feedback questionnaires. Functional performance (Short Physical Performance Battery and Timed Up and Go Test), activities of daily living, and gait were outcomes for effectiveness. A high adherence rate (80.46%) and uniformly positive feedback indicate that the piloted training program is feasible. The results show preliminary effectiveness on functional performance (Short Physical Performance Battery mean t0 = 3.15; mean t1 = 4.50; p = .006) and gait (e.g., velocity mean t0 = 46.97; mean t1 = 58.04; p = .007).

In 2012, the World Health Organization (WHO) declared dementia as a public health priority (WHO, 2012). Since then, several important milestones have already been achieved, such as the first G8 summit on dementia (G8 Health Ministers, 2013), the development of 30 national dementia plans worldwide (Alzheimer’s Disease International, 2019), and the publication of the Global Action Plan on the Public Health Response to Dementia (WHO, 2017). However, the global prevalence of dementia is still increasing. Worldwide, 50 million people are living with dementia, and this number is predicted to triple, to 152 million people, by 2050 (WHO, 2020). Despite intensive research efforts, pharmacological interventions have not been able to modify the clinical trajectory of dementia yet. Alternatively, research on nonpharmacological disease-modifying strategies has gained popularity. This is also reflected in the global action plan to double research on dementia between 2017 and 2025 (WHO, 2017).

In this context, physical activity is one of the most investigated and promising nonpharmacological treatments. Research has shown that physical activity reduces the risk of dementia (Najar et al., 2019; Stephen, Hongisto, Solomon, & Lönnroos, 2017; Xu et al., 2017). Furthermore, physical activity has the potential to slow down functional loss during the progression of the disease (Ginis et al., 2017; Laver, Dyer, Whitehead, Clemson, & Crotty, 2016). The positive effects of physical activity on cognition (Du et al., 2018; Jia, Liang, Xu, & Wang, 2019), physical functioning (Zeng et al., 2016), and improvements in the ability to perform activities of daily living (Forbes, Forbes, Blake, Thiessen, & Forbes, 2015) are repeatedly documented in intervention studies of people with dementia.

However, because of heterogeneity in the type, frequency, and duration of physical activity interventions, as well as the methodological limitations of the trials, the reported effects of physical activity on people with dementia have to be interpreted with caution. Until now, evidence from which to derive physical activity guidelines for people with dementia has been insufficient (Forbes et al., 2015; Peek et al., 2020). Furthermore, the general activity guidelines for adults aged 65 years and above (WHO, 2010) do not correspond to the special needs of the target group (Baert, Gorus, Calleeuw, De Backer, & Bautmans, 2016; Ginis et al., 2017).

Besides the research gap concerning the most effective training regime for people with dementia, there is a lack of evidence concerning the feasibility of physical activity programs in different care settings. The most important institutional settings in dementia care are nursing homes. The percentage of residents receiving institutional long-term care who live with dementia has increased over the last two decades (Matthews et al., 2016), up to 85% nowadays (Auer et al., 2018). Compared with their cognitively healthy peers and community-dwelling people with dementia, institutionalized people with dementia are disadvantaged concerning physical activity in a threefold way. They are less physically active, have a higher risk of falling, and are much more frail (Allali et al., 2017; Hartman, Karssemeijer, van Diepen, Olde Rikkert, & Thijssen, 2018; Kosse, de Groot, Vuillerme, Hortobágyi, & Lamoth, 2015; van Alphen et al., 2016).

Besides considering institutionalized patients’ restricted mobility, physical activity programs should consider implementing organizational conditions that integrate physical activity into the daily routines of nursing homes (de Souto Barreto et al., 2016). Nursing staff and relatives consider staffing, timing, resources, and the environment to be potential barriers to institutionalized people with dementia being able to participate in physical activity (Brett, Traynor, Stapley, & Meedya, 2018). Therefore, those planning interventions have to consider these barriers. Moreover, the voices of all stakeholders (staff, relatives, and facility managers), as well as the residents’ desires, preferences, beliefs, and attitudes toward physical activities, have to be integrated into the program development (de Souto Barreto et al., 2016).

Crocker et al. (2013) recommended promoting enjoyment of and satisfaction with the intervention by means of individualization. This in turn improves participants’ motivation and compliance. To include people with lived experience in the development process of health-enhancing interventions is a key principle of health promotion and is also becoming much more common among people with dementia (Bethell et al., 2018). Even though Alzheimer Europe calls for the intense involvement of people with dementia in all research areas (Gove et al., 2018), physical activity intervention research so far has neglected this demand. Applied equipment in intervention studies, for example, treadmills (Arcoverde et al., 2014), leg presses (Garuffi et al., 2013), cycling ergometers (Hauer et al., 2012), and other machine-based training regimes hardly reflect residents’ desires and preferences. Furthermore, these studies most likely fail to tie in with participants’ physical activity biography or interests (Gebhard & Mir, 2021). Most physical activity programs using the label tailored or individualized focus on the physical conditions of people with dementia, for example, customizing the intensity and progression of the exercises. With this procedure, the programs fail to emotionally tailor or individualize interventions. They fail to include physical activities that people with dementia enjoyed during their lives and probably wish to maintain or readopt.

Biography-based approaches are broadly used in other health-enhancing contexts, for example, in reminiscence therapy with people with dementia (Elfrink, Zuidema, Kunz, & Westerhof, 2018). Furthermore, research has shown that biography-based approaches have great potential in the field of physical activity (Malthouse & Fox, 2014; van Alphen, Hortobágyi, & van Heuvelen, 2016) and possibly promote training adherence in people with dementia (van der Wardt et al., 2017).

Consequently, the aforementioned research gaps indicate a strong need for specific physical activity interventions addressing the highly vulnerable group of institutionalized people with dementia. These interventions should (a) consider organizational conditions of long-term care facilities; (b) include the perspectives of all stakeholders; (c) consider residents’ desires, preferences, beliefs, and attitudes toward physical activities; (d) include biographical approaches; and (e) be individually tailored in relation to functional performance.

Addressing this desideratum, a physical activity intervention was developed within the project “Health in Motion 2.0.” The project was supported by Fonds Gesundes Österreich under grant number 2622. The physical activity program was piloted from April 2016 to November 2016 in five nursing homes in Carinthia (Austria). The Carinthia ethics committee approved the study (ethics committee approval A 17/15). The trial was registered in the German Clinical Trials Register and the WHO International Clinical Trials Register Platform (ID: DRKS00017165).

The objective of this pilot study was to evaluate the feasibility and effectiveness of an evidence-based physical activity program for institutionalized people with dementia, which was developed with the participation of residents with dementia and their care staff and can be individualized with regard to participants’ biographies and competences.

Methods

Study Design

The study was designed as a multicenter, randomized, controlled intervention trial embedded into a mixed-methods intervention evaluation (Drabble & O’Cathain, 2015). The intervention’s feasibility was measured using a feasibility questionnaire completed directly after each training session, as well as by means of focus groups with the participants during the last training session. A test battery was performed before randomization (t0) and at the end of the intervention (t1) to investigate the effectiveness of the program. The different methodological approaches were conducted within a convergent design, so qualitative and quantitative data were collected and analyzed separately during a similar timeframe (Fetters, Curry, & Creswell, 2013).

Participants

All residents of five nursing homes in Carinthia (Austria; n = 361) were screened for eligibility between January and March 2016. Residents fulfilling the following criteria were included in the study: (a) dementia diagnosis with a Mini-Mental State Examination (MMSE) score from 10 to 26 points (indicating mild-to-moderate dementia; German Society for Neurology, 2016), (b) aged 60 years or over, (c) no participation in structured physical activity programs during the last 6 months, and (d) wish to participate for 12 weeks in a group-based physical activity program. Bedridden residents were excluded. All participants, as well as their guardians (in case of legal representation), their physicians, and responsible care directors in long-term care facilities, provided written informed consent. Additionally, the participants provided assent before every exercise session. Situational dissent concerning participation was respected at any time. Residents meeting the inclusion criteria were randomly assigned to the intervention group (IG) or the control group (CG) per facility, using the blockrand procedure conducted by an independent statistical consultant with the statistic program R (R Foundation, Vienna, Austria). The participants were informed about their allocation to IG or CG after baseline assessments. The funding provided allowed a maximum of five nursing homes to be included in the trial. A priori sample size calculation was not carried out. This study has to be classified as a pilot study (cf. Kraemer, Mintz, Noda, Tinklenberg, & Yesavage, 2006) with feasibility as the main objective. Furthermore, in mixed-methods approaches (quantitative and qualitative methods), it is common to dispense with power calculations (Sandelowski, 1995).

The participants assigned to the CG received standard care. Since none of the five participating nursing homes provided physical activity programs or other interventions to reduce sedentary behavior, the participants in the CG did not exercise during the 12-week intervention phase. After t1, they were invited to attend the training program. Therefore, neither the participants nor the instructors were blinded concerning the allocation of participants in the intervention or control arm of the study.

Intervention

Figure 1 illustrates the development and individualization process of the physical activity intervention. The development of the physical activity intervention followed a transdisciplinary mixed-methods approach. The results of a systematic review (Gebhard, 2016), workshops with nursing staff (Gebhard & Schmid, 2018), and interviews with institutionalized people with dementia (Gebhard & Mir, 2021) were merged through a convergence coding matrix (Farmer, Robinson, Elliott, & Eyles, 2006). During the 3-hr workshop, hindrances and facilitating factors for successfully implementing physical activity programs in nursing homes were discussed by 32 nurses in five groups. The interviews aimed to investigate motivators and barriers, as well as wishes, attitudes, and experiences concerning the physical activity of 10 people with dementia.

Figure 1
Figure 1

Program development and individualization.

Citation: Journal of Aging and Physical Activity 2021; 10.1123/japa.2020-0343

The resulting multicomponent training program lasted 12 weeks. Training sessions took place twice a week, each lasting 60 min. The training sessions were held in small groups of four to 12 participants. This training schedule was set at the intersection between recommendations from workshops and the systematic review. Workshop participants recommended a maximum frequency of two 1-hr training sessions per week as sustainably includible into the daily routines of nursing homes (Gebhard & Schmid, 2018). The literature proposes a minimum of two training sessions per week, with a duration of 45–60 min and a training period of 12 weeks, as effective with this target group (Blankevoort et al., 2010; de Souto Barreto et al., 2016; Pitkälä, Savikko, Poysti, Strandberg, & Laakkonen, 2013). Furthermore, a program lasting a maximum of 12 weeks shows lower attrition rates than those of longer programs in nursing home residents (Yang et al., 2020).

The training regime was based on the Otago Exercise Program (Campbell & Robertson, 2003) and included 10 simple and effective basic exercises to train resistance and balance: knee extensors, sit-to-stand, climbing stairs, raise arms, raise legs sideward, toe-heel, moving sideward, moving backward, figure-of-8 walking, and tandem stance. These basic exercises were complemented by endurance sequences of walking. Based on physical activity biographies and the wishes of the interviewed people with dementia, these 10 basic exercises and walking sequences were integrated into four meaningful activity topics, namely, (a) nature, (b) dancing, (c) daily activities, and (d) sports and games. To embrace the dementia-specific approach, six key principles were defined for a didactical concept in institutionalized people with dementia: (a) communicate in a tailored and respectful way, (b) convey joy and fun, (c) use meaningful music to trigger physical activity, (d) use nature as a stimulating environment for exercising, (e) have flexible timeframes, and (f) use familiar materials of a demanding character.

Together, these cornerstones led to the development of 33 exercise units, each combining basic exercises for resistance and balance with endurance sequences of walking. All exercise units were adaptable to three mobility levels (no impairments, mobile with stick or rolling walker, and mobile with wheelchair), and moreover, they were individually adjustable based on the participants’ competencies, by changing the length of the walking distances, the sizes of the weights used, or the number of repetitions.

All training sessions followed the same structure: all started and finished with a 5-min activity poem for warm-up and cooldown, and included at least two exercise units with a 5-min drinking break in between. In Supplemental Material I (available online; example training session), an exercise session is presented in detail.

For training instruction, specific communication strategies were applied (Oddy, 1998). Communication strategies, for example, included simple and direct instructions, asking for one aspect at a time, using familiar words, speaking slowly, and repeating instructions several times. Verbal instructions were complemented by demonstrating the movement patterns continuously and by tactile as well as rhythmic cues, or visual as well as acoustic signs. The didactical concept and all exercise units are described in detail in a comprehensive manual (Gebhard & Schmid, 2017).

To individualize the program developed with respect to the physical capacity and biographies of the participants, two sources of information were used (see Figure 1, individualization): (a) short interviews about the physical activity biography, current desires regarding physical activity, taste in music as well as favorite songs, and individual goals associated with participating in the physical activity program and (b) participants’ baseline data of functional performance. This information was drafted for each participant into a one-page summary, including the definition of the training level and recommendations concerning training intensity and progression (e.g., numbers of repetitions and walking distances). This summary provides some kind of individual motor profile (Kemoun et al., 2010), which has two aims within the individualization process. First, the information regarding the individual experiences and preferences was integrated into training implementation. To promote the participants’ motivation to participate actively in the training sessions, their individual relation to specific exercise units and songs was verbally pointed out at the beginning of each training session. Second, in the synopsis of all profiles, the combination of exercise units for the physical activity program was selected for each training group according to the biographies, interests, and functional performance levels of the group members. For example, if there were many participants with an agricultural background in one training group, the thematic focus for the compilation of exercise units within the 12-week training program was set to the topic “nature” in this particular training group. However, in the other group, for example, including many participants with experiences in games, such as football, tennis, or bowling, the thematic focus of the exercise units was set to the topic “sports and games.” Furthermore, an individual music playlist was composed for each training group.

The participants’ profiles, 24 individualized training sessions, and an audio CD were included in an individualized training manual for every training group, and this built the foundation for the implementation of the intervention. A team of at least two educated nurses led the training sessions for people with dementia, supported by weekly mentoring.

Education Program for Care Staff

Based on the training manual, an educational program was developed, which enabled nursing home staff to implement the physical activity program developed in a high-quality and safe way. The educational program was led by an interdisciplinary team (psychologist, physiotherapist, dementia care expert, and health promotion expert) on two weekends in February 2016, and it consisted of 26 teaching units of 45 min each. The education program contains five parts: (a) general introduction to the topic of dementia (symptoms, progression, and treatment), (b) introduction to the topic of dementia and physical activity (effectiveness, perspectives of people with dementia, and care staff on physical activity), (c) training didactics for people with dementia (verbal and nonverbal communication), (d) introduction to the training program (theory and practice), and (e) practical mentoring session in each long-term care facility. In total, 33 persons participated in the education program.

Outcomes and Measurements

Feasibility

Dropout rate, reasons for dropout, adherence rate, reasons for nonattendance, training environment, occurrence of adverse events, and the applicability of the exercise units developed and satisfaction with the practical implementation were defined as outcomes for feasibility.

Training adherence was documented as a percentage of the training sessions successfully completed. Applicability and satisfaction were assessed for all the exercise units developed, by rating the following aspects on a 4-point Likert scale (1 = disagree, 2 = rather not agree, 3 = rather agree, 4 = agree):Two training instructors collaboratively documented and rated the feasibility directly after each training session.

  1. excessive or insufficient demands,
  2. joy of training participation,
  3. possibility of tailoring the exercise units to individual needs of all participants,
  4. joy of training instruction, and
  5. simplicity of training instruction.

Effectiveness

For the quantitative examination of the program’s effectiveness functional performance, the activities of daily living and gait performance were defined as primary outcomes. Quality of life and communication as well as interaction skills were defined as secondary outcomes. Only measurements developed especially for cognitively impaired individuals or validated in people with dementia were applied.

Primary indicators for effectiveness

Functional performance was measured by the Short Physical Performance Battery (SPPB; Guralnik et al., 1994) and the Timed Up and Go test (TUG; Podsiadlo & Richardson, 1991). The SPPB measures stance balance in three progressive levels, gait pace over a distance of 4 m, and lower limb strength by means of a timed chair stand test with five repetitions. The highest score for each category is four points, resulting in a maximum score of 12. The TUG measures the time a person needs to stand up from a chair, walk 3 m, turn, walk back to the chair, and sit down. Following recommendations, the time was taken twice and the mean was included in the analysis. Both testing procedures have excellent reliability, with an intraclass correlation coefficient (ICC) between .88 and .92 (SPPB; Ostir, Volpato, Fried, Chaves, & Guralnik, 2002) and .91 and .98 (TUG; Ries, Echternach, Nof, & Gagnon Blodgett, 2009), respectively.

The activities of daily living were assessed using the German version of the Bayer Activities of Daily Living Scale (B-ADL)—a proxy-rating instrument especially developed for cognitively impaired people (Erzigkeit & Lehfeld, 2010). The instrument includes 25 items rated on a 10-point Likert scale. Lower scores indicate better performance. The internal consistency of the instrument is excellent (Cronbach’s > .9), and the test–retest reliability in people with dementia is between .66 and .75 (Erzigkeit et al., 2001; Erzigkeit & Lehfeld, 2010). Following recommendations, questionnaires were only included in the analysis if a minimum of 18 items were assessed.

Gait performance, including velocity, cadence, stride time, and stride length, was measured via the GAITRite system, an electronic sensor mat 579 cm in length and 90 cm in width. The system has been successfully validated for use in people with dementia, with an ICC between .88 and .99 (Wittwer, Webster, Andrews, & Menz, 2008). The participants were instructed to walk on the mat at a comfortable pace while using their standard mobility device, if any. The start and end point of the walk was set at least 1 m in front of and behind the mat to exclude gait initiation and termination phases from the analysis. Two rounds were performed, and the one with a higher cadence (steps per minute) was included in the analysis.

Secondary indicators for effectiveness

Quality of life was assessed using the German version of the QUALIDEM (Dichter et al., 2016), a proxy-rating instrument especially developed for institutionalized people with dementia. The version for people with mild-to-moderate dementia includes 37 items rated on a 4-point Likert scale. The instrument shows a good intrarater reliability (ICC .70), but an insufficient interrater reliability (ICC < .70), which can be improved by using a collaborative rating performed by two caregivers (Dichter et al., 2014, 2016). This recommendation was considered for this trial.

Communication and interaction skills were assessed by the German version of The Assessment of Communication and Interaction Skills (ACIS; Forsyth, Simon, Salamy, & Kielhofner, 2011). The ACIS is an observation instrument that has 20 items across three subscales: (a) body, (b) information exchange, and (c) relationship. Two independent raters observed the person being assessed in a meaningful social context for at least 45 min. This observation allowed them to rate the behavior of the person afterward with the ACIS. The observation was performed during training sessions 2 and 23, only in IG.

Trained occupational therapy students, blinded to the participants’ group allocation, executed the functional performance tests and measurement of the gait characteristics. Since the observation of communication and interaction skills was conducted during the training session, blinding was not possible. The QUALIDEM and the B-ADL had to be rated within 2 weeks before and after the intervention by the participants’ primary caregivers. Therefore, blinding could not be ensured completely.

Participants’ feedback

Focus groups were conducted within every training group during the last training session to collect feedback on the feasibility and effectiveness of the training program directly from people with dementia. To deal with challenges associated with qualitative dementia research (Carmody, Traynor, & Marchetti, 2015), specific recommendations during data collection were considered. Focus groups were embedded into the last training session, and they worked with pictures of all the training sessions as visual prompts to facilitate better reminiscence and support their verbal communication (Cridland, Phillipson, Brennan-Horley, & Swaffer, 2016). The interview guideline was based on qualitative surveys of people with dementia in the field of physical activity (Olsen, Wiken Telenius, Engedal, & Bergland, 2015; Yu & Swartwood, 2012). The questions functioned as an impulse for storytelling. They were short and included only one aspect per question (Cridland et al., 2016):All training participants were continuously addressed directly by name to encourage contribution. The questioning and communication style were continuously tailored to the individual’s needs, including rewording or repeating questions, as well as giving further explanations or examples. The focus groups were conducted by a researcher experienced in interviewing people with dementia. All interviews were audio recorded and transcribed verbatim.

  1. How did you like the training progra?
  2. What did you like most?
  3. What did you like least ?
  4. Which effects did you perceive from exercising?

Analysis

Quantitative data

For baseline comparison, a Shapiro–Wilk’s test was conducted to test the distribution of variables. An unpaired t test was used for normally distributed metric data, and a Mann–Whitney U test was used for nonnormally distributed data. A chi-square test was conducted for nominally scaled variables.

Due to the results of the systematic review of Pitkälä et al. (2013), indicating that training once a week is not effective in this target group, the minimum adherence rate of 50% was defined in the study protocol as the inclusion criterion for the analytic sample. A per-protocol (PP) analysis was preferred over an intention-to-treat analysis. To include all participants who were randomized (intention-to-treat analysis) in the same way in the analysis, irrespective of whether they participated in one session or 24 sessions, would considerably limit any evidence regarding the effectiveness of the intervention (Gupta, 2011).

Therefore, following a PP analysis, only participants without protocol violation (dropout from trial or <50% adherence rate) were included in the sample analyzed. Furthermore, no imputation methods to estimate missing data were applied.

For within-group comparison, a paired t test was conducted for normally distributed data, and a Wilcoxon test was used for nonnormally distributed data. For Group × Time effects, a two-factor analysis of variance with repeated measures was performed. The differences were considered statistically significant with p < .05 for all analyses.

To identify the predictors of training response, multivariate regression analysis was applied. Therefore, significantly improved outcomes were defined as dependent variables for a multivariate regression model. Sex, age, MMSE value, and adherence were preliminarily defined as independent variables. At the beginning of the process, all variables were included in the model, following the exclusion criterion of p ≥ .100; they were excluded step by step and backward. The modeling process is completed as soon as a combination of variables (multiple linear model) or one single variable (simple linear model) can predict the dependent variable, or in the case that none of the independent variables can predict the dependent variable. The effect sizes were interpreted following Cohen’s (1988) classification (small effect sizes: R2 ≤ .08; medium effect sizes: R2 = .09–.24; and large effect sizes: R2 ≥ .25). Statistical analysis was performed using SPSS Statistics (IBM Corporation, Version 23.0. Armonk, NY).

Qualitative data

Focus group transcripts were analyzed using qualitative content analysis based on Mayring (2015). Deductive as well as inductive procedures were used for the development of the categories. Techniques of summarizing, as well as content-related structuring and scaling structuring, were applied. Following the questions, four deductive categories were derived: (a) feedback on the training program—overall (categories: very positive, rather positive, neutral, rather negative, and very negative), (b) feedback on the training program—specifically positive aspects (inductively built categories), (c) feedback on the training program—specifically negative aspects (inductively built categories), and (d) effectiveness of the training program (inductively built categories).

Results

Sample

Figure 2 shows the flow diagram of progress through the phases of enrollment, intervention allocation, follow-up, and analysis. Starting with the screening of all 361 residents of five nursing homes, 65 people were randomized, and 63 people were included in the baseline measurements in April 2016 and participated in the 12-week intervention from April to June 2016. The average age of the participants was 86.21 years (SD = 7.51), and 77.80% were female, with a mean MMSE value of 19.19 (SD = 4.61). Table 1 shows the baseline characteristics of each group in detail. Most baseline scores on the outcome measures did not differ significantly between groups, except for the quality of life and activities of daily living. Since 13 participants were not able to walk, and the walks of three persons could not be analyzed with the GAITRite system due to their shuffling gait, the results of TUG are based on the data of 50 participants, and the results for the gait characteristics are based on the data of 47 participants. Over the 3-month intervention period, 10 people dropped out (15.87%) and two persons violated the protocol because they attended only 10 out of 24 sessions and were therefore excluded from the analysis of effectiveness but not from the assessment of feasibility. The baseline scores of the 12 excluded participants did not differ significantly from the group of participants who were analyzed.

Figure 2
Figure 2

Participant flowchart.

Citation: Journal of Aging and Physical Activity 2021; 10.1123/japa.2020-0343

Table 1

Baseline Characteristics

IGCG
CharacteristicsMean (SD)nMean (SD)np value
Agea86.09 (7.64)3486.34 (7.49)29.989
Sex, female (%)79.40%3475.90%29.736
MMSEa18.59 (4.60)3419.90 (4.60)29.239
SPPBa3.18 (2.37)342.48 (2.34)29.202
TUGa (s)34.32 (19.55)2840.35 (18.39)22.165
QUALIDEMa85.10 (13.57)3176.54 (16.31)28.030
B-ADLa6.27 (2.51)347.55 (1.87)29.045
Velocitya (cm/s)48.45 (19.42)2850.89 (27.16)22.818
Cadence (steps/min)80.93 (19.94)2883.94 (20.51)19.641
Stride timea (s)0.79 (0.21)280.78 (0.25)19.845
Stride length (cm)37.99 (10.41)2835.03 (11.13)19.833
Stride widtha (cm)9.06 (4.52)289.44 (4.17)19.967

Note. Scores: SPPB = 0–12, higher values indicate better physical functioning; QUALIDEM = 0–111, higher values indicate higher quality of life; B-ADL = 0–10, lower values indicate higher competencies in activities of daily living; IG = intervention group; CG = control group; MMSE = Mini-Mental State Examination; SPPB = Short Physical Performance Battery; TUG = Timed Up and Go test; B-ADL = Bayer Activities of Daily Living Scale.

aNormally distributed metric data.

Feasibility

As outlined in Figure 2, the dropout rate within the IG was 14.7%. Two participants dropped out due to hospitalization, and three withdrew their participation without giving reasons. The two persons who dropped out due to hospitalization attended two and six training sessions respectively; the three persons who withdrew from participation dropped out (a) before the first training session, (b) after attending one training session, and (c) after four training sessions.

For all 34 persons allocated to the intervention, the average attendance rate was 70.8% (17.06 training sessions; SD = 6.62). When excluding the five persons who dropped out, the attendance rate was 80.46% (19.31 training sessions on average, SD = 3.93). Excluding the two persons who violated the protocol (minimum attendance of 50%) due to an attendance of 10 out of 24 sessions, the 27 participants of the analytic sample attended 20 (SD = 3.08) out of 24 training sessions on average (83.3% adherence rate). Table 2 outlines the reasons for the nonattendance of all participants who were not defined as dropouts (n = 29).

Table 2

Reasons for Nonattendance

Reasons for nonattendanceFrequencies%
Health complaints3223.02
Refusal to participate2820.14
Other appointments (e.g., medical appointment, hairdresser)2215.83
Hospitalization1510.79
Visitors1410.07
Activity session was not held128.63
Other reasons (e.g., fear of going outdoors)96.47
Basic care was not finished75.04
Total139100

In total, 38.14% sessions were conducted in the outdoor environment of the nursing homes. Across all five nursing homes and training sessions, the average group size was 4.92 participants. No adverse events, such as falls, occurred during the training sessions within the 12-week training period.

In all, the exercise units developed were rated 226 times directly after implementation; in total, all exercise units were assessed between five and 20 times on a 4-point Likert scale. The possibility of tailoring the exercise units to participants’ individual needs was rated on average with 3.89 (SD = 0.18; higher values indicate positive ratings). The results further indicated the simplicity of the training instruction with an average rating of 3.88 (SD = 0.15) and high levels of joy with regard to participants (mean = 3.84, SD = 0.24) and instructors (mean = 3.87, SD = 0.20). The results showed almost no occurrence of excessive (mean = 1.11, SD = 0.2) or insufficient (mean = 1.06, SD = 0.08) demands (lower values indicate a lower occurrence).

Effectiveness

Table 3 shows the values of the baseline and follow-up assessments of IG and CG. Significant improvements were obtained in IG for functional mobility, physical performance (SPPB—total, SPPB—balance, and SPPB—gait test), activities of daily living, communication and interaction skills, velocity, and cadence, as well as stride time. No significant within-group differences were found within the CG. Significant Group × Time differences were found for physical performance (SPPB—total, SPPB—balance, and SPPB—gait test) and for all gait parameters.

Table 3

Within-Group Differences and Group × Time Differences

IGCG
PrePostPrePost
OutcomesMean (SD)nMean (SD)np valueMean (SD)nMean (SD)np valueGroup × Time,

p value
TUG (s)34.12 (21.12)2231.96 (20.31)22.04038.59 (17.26)1834.92 (19.15)18.918.230
SPPB—total3.15 (2.43)274.50 (2.86)24.0022.58 (2.43)242.50 (2.40)24.817.006
SPPB—4-m gait test1.48 (1.16)271.96 (1.16)24.0081.58 (1.25)241.33 (1.34)24.327.002
SPPB—balance1.11 (1.12)271.83 (1.37)24.0160.75 (1.15)240.83 (1.01)24.604.049
SPPB—chair rise0.56 (0.75)270.71 (0.91)24.1020.25 (0.61)240.33 (0.64)24.414.332
B-ADL6.37 (2.33)275.02 (2.94)22.0127.36 (1.98)237.19 (2.33)22.648.101
QUALIDEM83.67 (13.28)2482.58 (11.51)24.77079.52 (14.21)2382.62 (17.19)21.374.342
Velocity (cm/s)46.97 (21.30)2258.04 (21.71)22.00153.46 (26.87)1950.27 (26.42)18.619.007
Cadence (steps/min)78.45 (19.84)2288.34 (15.02)21.00383.81 (20.17)1685.55 (22.80)17.877.038
Stride time (s)0.82 (0.22)220.70 (0.13)21.0030.79 (0.26)160.77 (0.25)17.877.010
Stride length (cm)37.07 (11.34)2240.41 (10.96)21.05336.19 (11.20)1633.88 (11.41)17.156.023
ACIS8.75 (2.24)2510.01 (1.93)27.003

Note. Scores: SPPB—total = 0–12; SPPB—4-m gait test = 0–4; SPPB—balance = 0–4; SPPB—chair rise = 0–4, higher values indicate better physical functioning; B-ADL = 0–10, lower values indicate higher competencies in activities of daily living; QUALIDEM = 0–111, higher values indicate higher quality of life; ACIS = 3–12, higher values indicate higher communication and interaction skills. IG = intervention group; CG = control group; TUG = Timed Up and Go test; SPPB = Short Physical Performance Battery; B-ADL = Bayer Activities of Daily Living Scale; ACIS = Assessment of Communication and Interaction Skills.

Predictors of Training Response

Because of significant within-group improvements, SPPB, TUG, B-ADL, and ACIS were included as dependent variables in multivariate regression models. Gait velocity was included as a key variable for improvements in gait characteristics.

Improvements in gait velocity (Δgait velocity = gait velocity [t1] – gait velocity [t0]) could be predicted by a simple linear model with the independent variable adherence ([yi] = –67.793 + 4.014 × xi; β = 0.55; R2 = .301; ΔR2 = –.127; p = .028). The zero was xi = 16.89 participations, indicating that if a person participated in at least 17 training sessions, an improvement in gait velocity was expected. The extent of the expected improvement in gait velocity increased with each additional training session by 4 cm/s on average.

Improvements in communication and interaction skills (ΔACIS = ACIS [t1] – ACIS [t0]) could be predicted by a simple linear model with independent variable adherence ([yi] = –6.64 + 0.37 × xi; β = 0.48; R2 = .232; ΔR2 = –.086; p = .037). The zero was xi = 17.95 participations, indicating that, if a person participated in at least 18 training sessions, an improvement in communication and interaction skills was expected.

Improvements in functional mobility (ΔTUG = TUG [t1] – TUG [t0]) could be predicted by a simple linear model with the independent variable sex ([yi] = 13.98 – 15.26 × xi; β = –0.54; R2 = .287; ΔR2 = −.083; p = .032), indicating that male participants showed greater improvement in functional mobility than female participants.

Improvements in the activities of daily living (ΔB-ADL = B-ADL [t1] – B-ADL [t0]) could be predicted by a multiple linear model with the independent variables (a) adherence (the more often a person participates the greater is the benefit), (b) sex (male participants have a greater benefit than female participants), (c) gait velocity (persons with higher gait velocity at baseline benefit more), and (d) functional mobility (persons with better functional mobility at baseline benefit more); (yi) = 18.92 – 2.43 × xi1 – 0.08 × xi2 – 0.10 × xi3 – 0.49 × xi4; β = 0.55; R2 = .682; ΔR2 = –.043.

No predictive variables could be found for improvement in physical performance (ΔSPPB = SPPB [t1] – SPPB [t0]).

Participants’ Feedback

All 27 participants took part in the focus groups. In accordance with the number of participants within the five training groups, two focus groups included four, two included six, and one included seven participants.

Feasibility

Overall feedback on the training program, in all five focus groups, was categorized as very positive. The following statements characterize the group discussions regarding the overall feedback.

Every time it was a great pleasure to participate.

I am of the opinion that everything was prepared very well.

Yes, I liked it. Every time I have been thinking about when the next session will be.

All focus groups discussed aspects they liked most about the training program, whereby multiple responses were possible. Most frequently, the participants liked everything on the program the most. Three groups liked exercising in the garden the most, and two groups discussed that they liked the ladies the most. The so-called ladies are the exclusively female research staff and health sciences students involved in mentoring the care staff during the training and conducting the interviews, tests, and observations. One group mentioned that they liked the voluntary nature of participation the most. The participants were also asked if there was something they liked the least concerning the training program. In all groups, there were no mentions concerning aspects the participants liked the least. Moreover, no group mentioned aspects they disliked.

Effectiveness

All five groups discussed specific positive effects of the training program. The following statements give an insight, and Table 4 summarizes these effects within inductively built categories.

My dizziness improved, it is almost completely gone!

Yes, I have improved a lot. I have been walking again and then I walked again.

Table 4

Perceived Aspects of Effectiveness

Aspects of effectiveness
General improvement of mobility
Becoming more agile
Aching muscles
(Pleasant) fatigue directly after the sessions
More awake directly after the sessions
Improvements of dizziness
More feelings
Physician confirmed the positive effect
Positive feeling of having people around you

Discussion

The aim of this mixed-methods randomized controlled trial was to investigate the feasibility and preliminary effectiveness of an evidence-based and participatorily developed physical activity program for institutionalized people with dementia, individualized by biography and competences.

Feasibility

The recruitment rate of 18.01% (65 out of 361) is comparable to other randomized controlled trials investigating physical activity interventions in institutionalized people with dementia (e.g., 17.25% in de Souto Barreto et al., 2016; 21.5% in Toots et al., 2019). The main reason why residents were not included in the study was the violation of inclusion criteria (74.79%; 270 out of 361), again comparable to similar studies (77.64% in de Souto Barreto et al., 2016; 61.57% in Toots et al., 2019). The most common reason why residents had to be excluded was the absence of a formal dementia diagnosis. Due to the fact that 69.7% of Austrian residents with no formal dementia diagnosis show significant signs of cognitive impairment (Auer et al., 2018), suggesting dementia, an assessment of cognitive status as part of the research project can be strongly recommended to increase the recruitment rate in future investigations.

However, 23.66% of the eligible residents (26 out of 91) declined to participate. Reasons for refusal may occur due to intra- and interpersonal barriers to physical activities (Gebhard & Mir, 2021), for example, lack of motivation for physical activity, fear of injuries and falls, or refusing group-based exercises. One way to help residents with dementia overcome these barriers could be a nonbinding offer to participate in a test physical activity session. This may help cautious residents to decide, on the basis of a realistic experience, whether they want to participate in the specific physical activity program or not.

Adherence to group exercise programs for institutionalized people with dementia varies widely between studies. Vseteckova et al. (2018) identified adherence rates between 25% and 84% in their systemic review. Considering this range, this study’s adherence of 80.46% (83.3% in the analytic sample) can be classified as high. The results suggest that the combination of a multifaceted didactical approach, biographical tailoring, and competence-based individualization may be a promising strategy in this population. Identifying specific factors that influence people with dementia to participate in the physical activity intervention is challenging. Participants’ perception of the intervention’s relevance and benefit for their lives may increase intervention fidelity (Crocker et al., 2013). Evidence on adherence-support strategies is still limited, mainly because of the absence of comparative studies. A wide range of adherence-support strategies, such as goal setting, social support, individual tailoring, or the inclusion of music, are applied in physical activity programs for people with dementia. Nevertheless, recent systematic reviews fail to identify effective approaches (Nyman, Adamczewska, & Howlett, 2018; van der Wardt et al., 2017). Vseteckova et al. (2018) presume, in a systematic review on the barriers and facilitators of adhering to group exercises, that people with dementia respond positively to a moderately challenging physical activity program or to a program tailored to their needs. The piloted program meets both requirements. It avoids excessive or insufficient demands. Furthermore, the results indicate a very high possibility of tailoring the exercise units to participants’ individual needs.

If and to what extent the inclusion of participants’ biographies benefits adherence could not be fully answered. However, individual preferences are identified as major intrapersonal motivators for physical activity (van Alphen, Hortobágyi, & van Heuvelen, et al., 2016). Furthermore, interviews with people with dementia indicate that a past experience of sports and exercise influences adherence to home-based exercising (Hancox et al., 2019). The focus groups in this study confirm this assumption with special regard to exercising outdoors. The participants in three out of five exercise groups stated that the outdoor training environment was a favorite aspect. Considering that the physical activity biographies of this generation are characterized by exercises performed outdoors (Gebhard & Mir, 2021), this finding indicates an outstanding appreciation of long-standing familiar training conditions. Moreover, this result is in line with previous studies confirming outdoor environments as valuable and enjoyable spaces for people with dementia when exercising (Cedervall, Torres, & Aberg, 2015; Olsson, Lampic, Skovdahl, & Engström, 2013).

Together with the outdoor implementation rate of close to 40% and the absence of adverse events in the outdoor environment, the results indicate that nursing homes’ gardens are a feasible, safe, and desired training environment for institutionalized people with dementia. This evidence may contribute to counteract staff’s, residents’, and nursing home managers’ perception of outdoor environments as a safety hazard for people with dementia (Evans et al., 2018; van den Berg et al., 2020). Moreover, the results can facilitate the inclusion of nursing home gardens in physical activity programs for institutionalized people with dementia as a matter of course—not only with the aim of raising training adherence, but also to provide a strong contrast to the low-stimulus environment indoors (Mjørud, Engedal, Røsvik, & Kirkevold, 2017), with additional health-enhancing effects (van den Berg et al., 2020).

Besides the valued aspect of the outdoor environment, the focus groups identified the voluntary nature of the physical activity program as a favorable aspect. Van der Wardt et al. (2017) suggested that this aspect of the exercise program is important for the adherence of nursing home residents with dementia. The explicit mention of voluntariness is surprising at first sight, especially from the point of view of a dementia researcher. Informed consent is an ethical obligation for intervention research in people with dementia (Alzheimer Europe, 2011). It is the responsibility of researchers to ensure the protection of the person’s autonomy, even when they have only a limited ability to consent. This was done in this study by obtaining double consent, which means gathering the proxy consent of the legal representative, as well as assent from the person with dementia, every time he or she participated in an exercise session. In contrast, involuntary treatments among people with dementia, such as physical restraints, psychotropic medication, or nonconsensual care, are parts of lived experience in people with dementia (de Boer et al., 2019; Moermans et al., 2018). Consequently, showcasing the voluntariness of an exercise program and promoting a feeling of autonomy within each training session by, for example, creating opportunities to codesign the exercises, can be new strategies to increase adherence in people with dementia. The Resident Engagement and Peer Support Model (Theurer et al., 2015) centers on resident contributions and peer support. It combines biographical approaches with the promotion of autonomy and empowerment of residents in developing and implementing activity programs in nursing homes. Using peer support in interventions is not a new approach for people with dementia (Keyes et al., 2016; Willis, Semple, & de Waal, 2018), but its application in physical activity interventions is quite innovative.

The documented reasons for nonattendance are mainly in line with existing literature. Biomedical reasons, physical and mental well-being, and low motivation are the main barriers to exercise participation in people with dementia (Bossers et al., 2014; Henwood, Neville, Baguley, Clifton, & Beattie, 2015; van Alphen, Hortobágyi, & van Heuvelen, 2016; Vseteckova et al., 2018). So far, the literature regarding the feasibility of exercise programs for institutionalized people with dementia does not focus on how to mitigate the reasons for nonattendance, but the results indicate some potential to increase adherence in this regard. Nearly one third of absences occur because of visitors, delayed basic care, or other appointments (e.g., medical appointment, hairdresser) being scheduled during the training session. These reasons can be prevented by the care staff better coordinating the residents’ daily routines. Dependency on other people is a major barrier to physical activity for people with dementia (van Alphen, Hortobágyi, & van Heuvelen, 2016). Specifically, a lack of support by caregivers is confirmed as a barrier to exercising in this target group (Baert et al., 2016; Hancox et al., 2019). Nevertheless, approaches to counteract these hindrances are mainly missing in program implementation strategies in long-term care. One way to reduce fears and refusals, as well as facilitate support among care staff, would be to raise awareness concerning the benefits of physical activity and to empower staff to be part of the implementation (Brett et al., 2018).

In parts, fostering care staff’s engagement has already been considered in this study by including them in the development process of the program and in their role as training instructors. The results suggest that this approach worked very well, as the instructors rated the exercise units as easily applicable and joyful for themselves. This can be considered to be an unexpected result, because even for experienced training instructors, exercising with people with dementia is challenging due to the special needs of the target group, as well as the requirement to execute the training regime safely but also effectively (Fjellman-Wiklund, Nordin, Skelton, & Lundin-Olsson, 2016). However, the educational program and the weekly mentoring of the trained care staff enabled them to guide the exercise program successfully. This result indicates the potential for sustainable training implementation in long-term care settings, without the need for external personnel. It has to be mentioned that all participating nursing homes continued the physical activity program after the end of the project.

However, the time-consuming nature of the education (26 units of 45 min) can be considered a barrier to the comprehensive implementation of the physical activity program in long-term care facilities in the future. Therefore, an abbreviated version of the educational program (10 units of 45 min) has been provided to care staff since 2018. The general introduction to the topic “dementia” was removed completely, the intensive discussion of theories and evidence as the basis of the physical activity program was reduced to the necessary minimum, the exercise units developed are carried out only exemplarily, and the on-site training is not implemented as part of the basic education.

Effectiveness

As this study is a pilot with the aim of exploring the implementation of a newly developed physical activity program for the first time, the results for effectiveness have to be categorized as preliminary. The program shows mixed effects on functional performance. These results are in line with (a) the systematic review of Zhang, Low, Gwynn, and Clemson (2019), indicating strong evidence that multicomponent training programs, focusing on strength and balance training combined with functional mobility training, improve gait in this target group, and (b) the meta-analyses of Zeng et al. (2016), showing the positive effects of physical activity on balance in people with dementia. However, in 2019, a consortium of people with dementia, informal caregivers, and professionals defined a core outcome set to evaluate physical activity interventions (Gonçalves, Samuel, Ramsay, Demain, & Marques, 2020). One out of seven outcomes is walking better. The present physical activity program shows a tendency to achieve this outcome.

In contrast, the exercises do not have a significant impact on the outcome being able to stand up and climb stairs (Gonçalves et al., 2020). Lack of improvement in the ability to stand up may also explain the lower effectiveness of the exercise program on TUG execution time. Multicomponent physical activity programs seem to be more effective in improving the ability to stand up than endurance training (Arcoverde et al., 2014), but the results are inconsistent (Bossers et al., 2014; Hauer et al., 2012; Suttanon et al., 2013; Zieschang, Schwenk, Oster, & Hauer, 2013).

The focus groups’ results also confirm the positive effects of being physically active on mobility and agility in the subjective perception of the participants. Together with quantitative findings on functional performance, the results may indicate that the exercise program contributes to the outcome staying healthy and fit (Gonçalves et al., 2020).

The current study does not show any quantitatively measurable effect of the intervention on quality of life. This result is in line with systematic reviews and analyses about exercises and quality of life in dementia (Holopainen, Siltanen, Pohjanvuori, Mäkisalo-Ropponen, & Okkonen, 2019; Ojagbemi & Akin-Ojagbemi, 2019). It remains unclear if the absence of evidence for exercise improving the quality of life is a matter of a lack of effectiveness or measurability (Holopainen et al., 2019). However, while quality of life is not an outcome defined by Gonçalves et al. (2020), in the thematic context, the consortium defined the outcome enjoying the moment. The highly rated joy of training participation in the present study suggests that the program has a positive impact on this outcome.

Activities of daily living improved significantly within the IG, but show no Group × Time effect. This result indicates that the applied multicomponent program shows promise in improving the ability to perform activities of daily living in people with dementia. This is in line with the latest Cochrane Review on exercise programs for people with dementia (Forbes et al., 2015), as well as a more recent review (Lam et al., 2018). The outcome set defined by Gonçalves et al. (2020) does not include activities of daily living, but does have the closely related outcome doing what you can do. The results of the present study show almost no occurrence of excessive or insufficient demands. This indicates an appropriate level of difficulty generated by individualization in order to give participants the feeling of successfully doing things.

The quantitative and qualitative results both indicate a positive impact of the program on social aspects in people with dementia. Except for a few studies (Parkinson & Milligan, 2011), little attention is being paid to the impact of physical activity programs on social outcomes in dementia research, although maintenance of communication and interaction skills enables people with dementia to stay socially connected and has the potential to support well-being and identity (Kindell, Keady, Sage, & Wilkinson, 2017). Positively perceived interaction is discussed in many studies as a facilitator of adherence and successful implementation of exercise programs in people with dementia (Hancox et al., 2019; Nyman et al., 2018), but the positive impact of involved research staff has been almost unnoticed as a social resource in this context so far.

With regard to Gonçalves et al. (2020), feeling useful and having a purpose seems to be most closely associated with social aspects. Han, Radel, McDowd, and Sabata (2016) found, in their literature synthesis, that the feeling of connectedness makes an activity meaningful for people with dementia. The findings of the present study suggest that the exercise program promotes a feeling of connectedness with others, indicating that it contributes essentially to this outcome.

However, if and to what extent these preliminary results of effectiveness are driven by either physical activity or by the manner in which it was implemented cannot be answered in the absence of an active CG. But it may be suggested that effects related to physical functioning are more strongly affected by the targeted promotion of physical activity, while the positive effects related to social aspects and the experience of joy and well-being are more strongly influenced by the didactical concept, particularly by the outdoor environment and the positive engagement with training instructors.

Predictors of Training Response

The findings suggest that adherence is not just a crucial indicator of feasibility, but essential for making predictions about the training response too. This general finding is in line with Schwenk, Dutzi, et al.’s (2014) and Rolland et al.’s (2007) results. In contrast to these authors, adherence in the presented study predicts the program’s effect on gait velocity, as well as communication and interaction skills, not on functional performance (Schwenk, Dutzi, et al., 2014) or activities of daily living (Rolland et al., 2007). Schwenk, Zieschang, et al. (2014) analyzed predictors of training effects on gait, but with a contrary result, comparable to that of the present study. In their study, adherence does not predict improvement. However, to the authors’ best knowledge, this study shows, for the first time, a dose–response relationship with a threshold value of 17 and 18 training sessions, respectively. On the basis of two training sessions per week, this minimal requirement falls below the recommended training duration of 12 weeks (Blankevoort et al., 2010; Pitkälä et al., 2013). Combined with Yang et al.’s (2020) findings, showing lower attrition rates in programs lasting 12 weeks or less, this result can be a starting point for developing physical activity guidelines in people with dementia concerning the minimum extent of an exercise program.

Unexpectedly, the regression analysis shows that cognitive capacity and age do not predict training response. This indicates that positive effects can be achieved even with highly aged and cognitively frail residents with dementia. Related to functional performance, these findings are in line with the results from Hauer et al. (2012), Schwenk, Dutzi, et al. (2014), and Schwenk, Zieschang, et al. (2014), but contradict Ghisla et al.’s (2007) results. Perhaps the fact that training success seems to be independent from participants’ cognitive status can be interpreted as an indicator for successfully tailoring training instructions and didactics to the cognitive levels and needs of all participants in the present program.

Beside sex and adherence, higher baseline values in gait and functional mobility predict effects on ADL as well. These findings are in contrast with the findings of Hauer et al. (2012), Schwenk, Dutzi, et al. (2014), and Schwenk, Zieschang, et al. (2014). These studies indicate that people with lower baseline levels benefit more from participating in an exercise program. The reasons for the inconsistent results might be the limited comparability of the studies. The participants in the present study have an average gait velocity of 48.45 (IG) and 50.89 cm/s (CG), respectively, while the samples in the other studies have a velocity of between 72.7 (Schwenk, Dutzi, et al., 2014) and 132.67 cm/s (Schwenk, Zieschang, et al., 2014). The present sample’s baseline values in functional mobility are lower compared with these aforementioned studies. This suggests that participants have to reach a certain functional level at baseline to make an improvement probable. When this functional threshold is exceeded, persons who are very close to this limit benefit more than persons who have better functional capacity. This line of argumentation is just a presumption. It is included for the sake of generating a starting point for further investigation.

Implications for Further Research

In order to contribute to WHO’s (2017) global target of doubling research on dementia, this pilot study provides implications for further research regarding the feasibility, effectiveness, and prediction of the training response. Future studies focusing on the feasibility of physical activity programs for people with dementia should investigate different adherence strategies, such as biographical approaches, different training environments, or goal setting comparatively within randomized and controlled study designs. Reasons for nonattendance must be documented more extensively, and interviews with people who withdraw from participation should be integrated into future evaluation concepts. An issue recommended for further research would be to evaluate whether a nonbinding offer to participate in a test physical activity session influences willingness to participate and can therefore increase recruitment rates in physical activity trials. The preliminary results for evaluating the effectiveness of the piloted physical activity program have to be confirmed in a follow-up trial with a more comprehensive study design, including an a priori power calculation of the sample size and active CG(s). However, the results suggest that the impact of physical activity programs on social outcomes has a high potential for further investigation. Finally, further research is needed to investigate the dose–response relationship in physical activity interventions for larger sample sizes of people with dementia and to explore how baseline functional capacity predicts training response.

Strengths and Limitations

The main strengths of the study are its consistent focus on the lived experience of people with dementia and the inclusion of the practical knowledge of the nursing home staff. The large majority of studies evaluating physical activity interventions in people with dementia solely aim to investigate quantitatively the effectiveness of exercises, ignoring the uselessness of an effective exercise program that is not feasible in practice. The applied mixed-methods and transdisciplinary approach facilitated a holistic analysis of the program’s feasibility and enabled preliminary insights into its effectiveness. Moreover, a dose–response relationship linked with the concrete threshold value of a minimum number of completed training sessions is presented for the first time, and new approaches to adherence strategies in people with dementia are discussed.

The main limitations are related to the methodological shortcomings of this study as a pilot. First, the current results have to be interpreted in light of the small sample size, which was further reduced due to the participants’ limited ability to participate in functional tests and the performed PP analysis. Even though intention-to-treat analyses are typical in this target group, the PP approach was chosen consciously due to the progressive decline of abilities in people with dementia and the pre–post design of the study (Gupta, 2011; Sanchez & Chen, 2006). Second, no power calculation was carried out a priori for the determination of the optimal sample size, so the results on effectiveness must be considered with caution and have to be categorized as preliminary. Third, the CG did not receive an alternative or placebo intervention. This study was designed as a pilot trial with a strong focus on investigating feasibility and was therefore not designed as a three-armed study with an active CG in addition to a standard care group. Therefore, it cannot be ruled out that the exercise program is equally effective and feasible as a comparable multicomponent training regime not focusing on individualization and not having a strong participatory character. Furthermore, it remains unclear if the effects are attributable to physical activity or to single aspects of the didactical concept, such as the outdoor environment or positive engagement with staff. Linked to the absence of a control intervention, it was also not possible to ensure the blinding of training instructors and raters. Furthermore, methodological weak points of the applied proxy-rating instruments limit the results.

Conclusion

The exercise program is feasible in institutionalized people with dementia. Preliminary results of effectiveness show that the program has the potential to effect physical functioning, gait, and the activities of daily living, as well as communication and interaction skills. People with dementia perceive health benefits and rate the exercise program positively. Being active in the outdoor environment is the favorite aspect. Nursing homes’ gardens can therefore be recommended as a safe and desired training environment with this target group. Educated nursing staff can easily apply the exercise units. In summary, the results suggest that the combination of 10 simple but effective basic exercises, embedded in a multifaceted didactical concept, individualized by biography and competences, may be a promising approach in this population. This can be a starting point to inform the development of physical activity guidelines for institutionalized people with dementia, especially concerning training didactics, implementation strategies, and pragmatic but effective training regimes. The most important lesson learned from this study is that investigating how physical activity should be provided is at least as important as asking what training regime is most effective when developing and implementing successful physical activity programs for this target group. Within this paradigm shift, physical activity can be more than just a nonpharmacological treatment replacing a lack of medications that could be used to slow down progressive loss in dementia. Physical activity can, in fact, become a joyful, health-enhancing, and socially rewarding part of life for institutionalized people with dementia.

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The authors are with the Department of Sport and Health Sciences, Technical University of Munich, Munich, Germany.

Gebhard (doris.gebhard@tum.de) is corresponding author.

Supplementary Materials

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