Effects of a 16-week multimodal exercise program on gait performance in individuals with dementia: a multicenter randomized controlled trial.

BACKGROUND: There is a high prevalence of gait impairments in individuals with dementia (IWD). Gait impairments are associated with increased risk of falls, disability, and economic burden for health care systems. Only few studies have investigated the effectiveness of physical activity on gait performance in IWD, reporting promising but inconsistent results. Thus, this study aimed to investigate the effectiveness of a multimodal exercise program (MEP) on gait performance in IWD. METHODS: In this parallel-group randomized controlled trial, we enrolled 319 IWD of mild to moderate severity, living in care facilities, aged ≥ 65 years, and being able to walk at least 10 m. The control group (n = 118) received conventional treatment, whereas the intervention group (n = 201) additionally participated in a 16-week MEP specifically tailored to IWD. We examined the effects of the MEP on spatiotemporal gait parameters and dual task costs by using the gait analysis system GAITRite. Additionally, we compared characteristics between positive, non-, and negative responders, and investigated the impact of changes in underlying motor and cognitive performance in the intervention group by conducting multiple regression analyses. RESULTS: Two-factor analyses of variance with repeated measurements did not reveal any statistically significant time*group effects on either spatiotemporal gait parameters or dual task costs. Differences in baseline gait performance, mobility, lower limb strength, and severity of cognitive impairments were observed between positive, non-, and negative responders. Positive responders were characterized by lower motor performance compared to negative and non-responders, while non-responders showed better cognitive performance than negative responders. Changes in lower limb strength and function, mobility, executive function, attention, and working memory explained up to 39.4% of the variance of changes in gait performance. CONCLUSIONS: The effectiveness of a standardized MEP on gait performance in IWD was limited, probably due to insufficient intensity and amount of specific walking tasks as well as the large heterogeneity of the sample. However, additional analyses revealed prerequisites of individual characteristics and impacts of changes in underlying motor and cognitive performance. Considering such factors may improve the effectiveness of a physical activity intervention among IWD. TRIAL REGISTRATION: DRKS00010538 (German Clinical Trial Register, date of registration: 01 June 2016, retrospectively registered, https://www.drks.de/drks_web/setLocale_EN.do ).

Cognitive change is more positively associated with an active lifestyle than with training interventions in older adults at risk of dementia: a controlled interventional clinical trial.

BACKGROUND: While observational studies show that an active lifestyle including cognitive, physical, and social activities is associated with a reduced risk of cognitive decline and dementia, experimental evidence from corresponding training interventions is more inconsistent with less pronounced effects. The aim of this study was to evaluate and compare training- and lifestyle-related changes in cognition. This is the first study investigating these associations within the same time period and sample. METHODS: Fifty-four older adults at risk of dementia were assigned to 10 weeks of physical training, cognitive training, or a matched wait-list control condition. Lifestyle was operationalized as the variety of self-reported cognitive, physical, and social activities before study participation. Cognitive performance was assessed with an extensive test battery prior to and after the intervention period as well as at a 3-month follow-up. Composite cognition measures were obtained by means of a principal component analysis. Training- and lifestyle-related changes in cognition were analyzed using linear mixed effects models. The strength of their association was compared with paired t-tests. RESULTS: Neither training intervention improved global cognition in comparison to the control group (p = .08). In contrast, self-reported lifestyle was positively associated with benefits in global cognition (p < .001) and specifically in memory (p < .001). Moreover, the association of an active lifestyle with cognitive change was significantly stronger than the benefits of the training interventions with respect to global cognition (ps < .001) and memory (ps < .001). CONCLUSIONS: The associations of an active lifestyle with cognitive change over time in a dementia risk group were stronger than the effects of short-term, specific training interventions. An active lifestyle may differ from training interventions in dosage and variety of activities as well as intrinsic motivation and enjoyment. These factors might be crucial for designing novel interventions, which are more efficient than currently available training interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01061489 . Registered February 2, 2010.

A Tablet-Based App to Support Nursing Home Staff in Delivering an Individualized Cognitive and Physical Exercise Program for Individuals With Dementia: Mixed Methods Usability Study.

BACKGROUND: The promotion of physical activity in individuals with dementia living in nursing homes is crucial for preserving physical and cognitive functions and the associated quality of life. Nevertheless, the implementation of physical activity programs in this setting is challenging, as the time and expertise of nursing home staff are limited. This situation was further exacerbated by the COVID-19 pandemic. Mobile health apps may be a sustainable approach to overcome these challenges in the long term. Therefore, the Individualized Cognitive and Physical Exercise-App (the InCoPE-App) was developed to support nursing home staff in delivering and implementing tailored cognitive and physical exercise training for individuals with dementia. OBJECTIVE: This study aims to assess the usability of the InCoPE-App in terms of user performance and user perception in a laboratory setting using a mixed methods approach. METHODS: Nursing home staff were encouraged to perform 5 basic tasks within the InCoPE-App. Their thoughts while using the app were captured by implementing a think aloud protocol. Then, participants completed the System Usability Scale questionnaire. The think aloud transcripts were qualitatively evaluated to unveil usability issues. All identified issues were rated in terms of their necessity to be fixed. Task completion (ie, success rate and time) and perceived usability were evaluated descriptively. RESULTS: A total of 14 nursing home employees (mean age 53.7, SD 10.6 years; n=13, 93% women) participated in the study. The perceived usability of the InCoPE-App, as assessed by the System Usability Scale questionnaire, can be rated as "good." The main usability issues concerned navigation logic and comprehensibility of app content. CONCLUSIONS: The InCoPE-App is a user-friendly app that enables nursing home staff to deliver and implement cognitive and physical exercise training for individuals with dementia in nursing homes. The InCoPE-App can be used with little training, even by people aged ≥50 years, who may have low digital literacy. To achieve sustainable use and high user satisfaction of the InCoPE-App in the long term, it should be implemented and evaluated in a field study.

A New Approach to Individualize Physical Activity Interventions for Individuals With Dementia: Cluster Analysis Based on Physical and Cognitive Performance.

BACKGROUND AND PURPOSE: Physical activity (PA) can have a beneficial effect on cognitive and physical performance in individuals with dementia (IWD), including those residing in nursing homes. However, PA interventions in nursing homes are usually delivered using a group setting, which may limit the effectiveness of the intervention due to the heterogenous nature of IWD. Therefore, the purpose of this study was to identify clusters based on cognitive and physical performance values, which could be used to improve individualization of PA interventions. METHODS: Based on the cognitive and physical performance variables of 230 IWD, a cluster analysis was conducted. Global cognition (Mini-Mental State Examination), mobility (6-Meter Walking Test), balance (Frailty and Injuries: Cooperative Studies of Intervention Techniques-subtest-4), and strength and function of lower extremities (30-Second Chair-Stand Test) were assessed, and values were used to perform a hierarchical cluster analysis with Ward's method. Differences in physical and cognitive performance as well as other secondary outcomes (age, sex, body mass index, use of walking aids, diagnosis and etiology of dementia, number of medications, and Cumulative Illness Rating Scale) were tested using 1-factorial analyses of variance. RESULTS AND DISCUSSION: Out of 230 data sets, 3-cluster solutions were identified with similar cluster sizes of 73 to 79. The silhouette coefficients for all calculated clusters ranged between 0.15 and 0.34. The cluster solutions were discussed in the context of cognitive and physical functions as well as training modalities and opportunities. The 4-cluster solution appears to be best suited for providing or developing an individualized PA intervention. CONCLUSIONS: The identified clusters of the 4-cluster solution may be used in future research to improve individualization of dementia-specific PA interventions. By assigning IWD to these clusters, more homogenous groups with regard to cognitive and physical performance can be formed. This allows for more individualized PA interventions and may result in a higher effectiveness, particularly in nursing homes. Our findings are relevant for therapists and nursing staff who design or deliver PA interventions in nursing homes or similar settings.

Effects of a 16-Week Multimodal Exercise Program on Physical Performance in Individuals With Dementia: A Multicenter Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Dementia affects physical as well as cognitive performance. In individuals with dementia (IWD), decline in physical performance increases with disease progression and is associated with higher functional dependence and decreased quality of life. It is paramount to examine factors that potentially preserve physical performance in IWD, particularly in light of conflicting findings on the effectiveness of physical activity interventions on physical performance of IWD, mainly due to limited number of high-quality studies, large heterogeneity in methods used, or insufficient reporting of methods. The aim of this study was to investigate the effects of a 16-week multimodal exercise program (MEP) combining physical and cognitive tasks on physical performance in IWD, and to identify individual characteristics of MEP responders. METHODS: A multicenter randomized controlled trial with assessment methods identified by an expert panel was conducted. We included 319 IWD of mild to moderate severity, older than 65 years, who underwent a standardized MEP specifically designed for IWD. At baseline and immediately after the MEP, we assessed physical performance (ie, mobility, balance, and strength) and function of lower extremities (primary outcomes). Potential effects of the MEP on physical performance were identified using 2-factor analyses of variance with repeated measurements within 2 samples (ie, intention-to-treat and per-protocol sample). Additionally, we compared characteristics related to physical performance between positive, non-, and negative responders. RESULTS AND DISCUSSION: Neither analysis procedure revealed statistically significant time×group effects. However, 28% to 40% of participants were positive responders with regard to balance, and strength and function of lower extremities; and these persons had statistically significant lower baseline performance in the corresponding assessments. CONCLUSIONS: This randomized controlled trial revealed no overall effects of the MEP on physical performance, probably due to high heterogeneity of the study sample. Findings in responder analysis showed that IWD with lower physical performance at baseline tended to benefit more than those with higher baseline performance. Thus, a higher degree of individualization of the MEP depending on baseline performance on IWD may improve overall MEP effectiveness.

Usability and Effectiveness of an Individualized, Tablet-Based, Multidomain Exercise Program for People With Dementia Delivered by Nursing Assistants: Protocol for an Evaluation of the InCoPE-App.

BACKGROUND: The COVID-19 pandemic has had drastic consequences on everyday life in nursing homes. Limited personnel resources and modified hygiene and safety measures (eg, no external exercise instructors, no group settings) have often led to interrupted physical exercise treatments. As a consequence, people with dementia benefiting from individualized exercise programs are affected by the pandemic's impact. OBJECTIVE: Our goal is to develop an easily applicable mobile application (Individualized Cognitive and Physical Exercise [InCoPE] app) allowing nursing assistants to test cognitive function and physical performance and subsequently train people with dementia through a multidomain, individualized exercise program. METHODS: We will evaluate the usability and effectiveness of the InCoPE-App by applying a mixed method design. Nursing assistants will use the InCoPE-App for 18 weeks to assess the cognitive function and physical performance of 44 people with dementia every 3 weeks and apply the individualized exercise program. We will record overall usability using questionnaires (eg, Post-Study System Usability and ISONORM 9241/10), log events, and interviews. Perceived hedonic and pragmatic quality will be assessed using the AttrakDiff questionnaire. Effectiveness will be evaluated by considering changes in quality of life as well as cognitive function and physical performance between before and after the program. RESULTS: Enrollment into the study will be completed in the first half of 2022. We expect an improvement in the quality of life of people with dementia accompanied by improvements in cognitive function and physical performance. The usability of the InCoPE-App is expected to be rated well by nursing assistants. CONCLUSIONS: To date, there is no scientifically evaluated app available that enables nursing assistants without expertise in sports science to deliver an individualized exercise program among people with dementia. A highly usable and effective InCoPE-App allows nursing assistants to test cognitive function and physical performance of people with dementia and, based thereon, select and deliver an appropriate individualized exercise program based on the cognitive and physical status of an individual, even in times of a pandemic. TRIAL REGISTRATION: German Register of Clinical Trials DRKS00024069; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024069. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36247.

ICT-Based Individualized Training of Institutionalized Individuals With Dementia. Evaluation of Usability and Trends Toward the Effectiveness of the InCoPE-App.

Physical activity interventions can alleviate the course of disease for individuals with dementia (IWD) who have been extraordinarily affected by the COVID-19 pandemic. Information and Communication Technology (ICT) provides new opportunities not only to mitigate negative effects of the pandemic but also to sustainably improve everyday life of IWD in nursing homes. The aim of the present study was to evaluate the ICT-based InCoPE-App, which was used to assess physical and cognitive performance and deliver individualized exercise for IWD, with regard to 1) user experience of nursing assistants, and 2) trends toward the effectiveness of the intervention on physical and cognitive performance of IWD. An 18-week individualized multidomain intervention (2 × 60 min/session) was delivered to an intervention group (IG; n = 10, mean age 88.4 ± 5.6, 70% female) by nursing assistants (n = 10, mean age 56.1 ± 10.4, 90% female) using the InCoPE-App. A control group (CG; n = 3, mean age 87.3 ± 3.5, 100% female) received conventional treatment. User experience was assessed among nursing assistants by different questionnaires, i.e., PSSUQ and ISONORM 9241/110-S for usability, and AttrakDiff2 for pragmatic (PQ), hedonic quality-identity and stimulation (HQI and HQS), and attractiveness (ATT). Trends toward the effectiveness of the intervention were assessed using MMSE (global cognitive function), FICSIT-4 (balance), 6MWT and TUG (mobility), and m30CST (function of lower limbs). Usability of the InCoPE-App was rated as high by nursing assistants (mean ± SD; overall PSSUQ 2.11 ± 0.75; overall ISONORM 9241/110-S 1.90 ± 0.88; ATT 1.86 ± 1.01; PQ 1.79 ± 1.03; HQI 1.8 ± 0.79; and HQS 1.37 ± 0.69). Dropout was high in the total sample (36.7%). Trends toward the effectiveness were observed within IG in nine IWD who showed positive or neutral trends in at least two physical performance outcomes. Seven participants had positive or neutral trends in the FICSIT-4, seven participants in m30CST, and four and seven participants in 6MWT and TUG, respectively. In conclusion, the InCoPE-App has good nursing assistant-rated usability, whereas training effects and intervention adherence were rather low most likely due to COVID-19 restrictions. Single-subject research revealed more positive than negative trends in IG of IWD. Further research is needed to evaluate feasibility, suitability, and effectiveness of the InCoPE-App.

Recommendations for assessing motor performance in individuals with dementia: suggestions of an expert panel - a qualitative approach.

BACKGROUND: Recommendations for assessing motor performance in individuals with dementia (IWD) are rare, and most existing assessment tools previously applied in IWD were initially developed for healthy older adults. However, IWD and their healthy counterparts differ in motor and cognitive capabilities, which needs to be considered when designing studies for this population. This article aims to give recommendations for motor assessments for IWD and to promote standardisation based on a structured discussion of identified assessment tools used in previous trials. METHODS: Appropriateness and standardisation of previously applied motor assessments for IWD were intensively discussed using a qualitative approach during an expert panel. Furthermore, the use of external cues and walking aids, as well as psychometric properties were considered. Starting with a comprehensive overview of current research practice, the discussion was gradually specified and resulted in the elaboration of specific recommendations. RESULTS: The superior discussion emphasised the need for tailoring motor assessments to specific characteristics of IWD and attaching importance to standardised assessment procedures. Specific recommendations include the use of sequential approaches, which incorporate a gradual increase of complexity from simple to more difficult tasks, a selection of motor assessments showing sufficient relative reliability and appropriateness for IWD, as well as allowing external cues and walking aids when restricted to repeated instructions and commonly used devices, respectively. CONCLUSIONS: These are the first recommendations for assessing motor performance in IWD based on a comprehensive qualitative approach. Due to limited evidence, it was not possible to address all existing questions. It is therefore important to evaluate these recommendations in studies with IWD. Besides tailoring and evaluating available assessments, future research should focus on developing specific tools for IWD. Moreover, further progress in standardisation is necessary to enhance comparability between different trials. This article provides initial approaches for overcoming existing limitations in trials with IWD by giving recommendations and identifying future research questions, and therefore contributes to enhancing evidence regarding efficacy and effectiveness of physical activity interventions.

Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. OBJECTIVE: This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial. METHODS: A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition). RESULTS: Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017. CONCLUSIONS: This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity. TRIAL REGISTRATION: German Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD).