Konzeption und Evaluation eines Bewegungsprogramms für demenzerkrankte Personen in vollstationären Altenpflegeeinrichtungen - Eine empirische Untersuchung

Hintergrund: Für die Therapie von hirnorganischen Demenzerkrankungen werden, neben pharmakologischen Therapieleistungen, nicht-pharmakologische Behandlungsformen wie körperliche Aktivität herangezogen. Körperliche Aktivität kann auf die kognitive und motorische Leistungsfähigkeit von Personen mit Demenz eine positive Wirkung haben. Eine gute Evidenzlage ist jedoch, bedingt durch den Mangel von zielgruppenspezifischen Bewegungsprogrammen, bis dato nicht eindeutig gegeben. Um diesem Mangel zu begegnen, wird in der vorliegenden Dissertation ein demenzspezifisches, multimodales Bewegungsprogramm (DMB) speziell für Personen mit Demenz konzipiert und mithilfe zweier Interventionsstudien im Sinne der Durchführbarkeit, Wirksamkeit und Implementierung wissenschaftlich evaluiert. Methodik: Studiendesign: Die kontrollierte Pilotstudie soll die Durchführbarkeit des DMB überprüfen und wird mit einer kleinen Stichprobe in zwei Altenpflegeeinrichtungen in einem pre- post Design durchgeführt. Die Hauptstudie "Bewegung gegen Demenz" wird als randomisierte, kontrollierte Interventionsstudie in 36 Altenpflegeeinrichtungen durchgeführt, um die Wirksamkeit und Implementierung des DMB mit einer großen Stichprobe im pre-post Design zu evaluieren. Einschlusskriterien: Voraussetzung für eine Teilnahme an der Pilotstudie sind das Vorliegen einer demenziellen Erkrankung sowie das Beherrschen der deutschen Sprache. Zur Teilnahme an der Hauptstudie ist entweder eine, den Kriterien der ICD-10 entsprechende, Verdachtsdiagnose auf eine hirnorganische, Demenzerkrankung oder eine bestehende ärztliche Diagnose vorzuweisen (leichter bis mittlerer Erkrankungsgrad, Mini-Mental State Test (MMST) 10-24). Mindestalter zur Teilnahme sind 65 Jahre, zudem muss eine Gehfähigkeit von zehn Metern (mit oder ohne Gehhilfe) vorliegen. Eine Einverständniserklärung und ärztliche Unbedenklichkeit zur Studienteilnahme sind erforderlich. Intervention: In der Pilotstudie nimmt die Interventionsgruppe (IG) zehn Wochen an einer verkürzten Form des DMB teil, welches sich aus rein motorischen und kognitivmotorischen Dual-Task Aufgaben zusammensetzt. Die IG der Hauptstudie besucht das DMB über einen Zeitraum von 16 Wochen. Testverfahren: Um die Durchführbarkeit des DMB zu überprüfen werden Teilnahmeund Drop-out Raten, Sicherheitsaspekte und die Protokolltreue in der Pilotstudie untersucht. Zudem werden erste Tendenzen zur Wirksamkeit des DMB in der Pilotstudie für die allgemeine kognitive Funktion (MMST), die psychomotorische Geschwindigkeit und Aufmerksamkeit (Trail Making Test A (TMT), die Mobilität (Timed Up and Go Test (TUG)), die Kraftfähigkeiten der unteren Extremität (der Five Times Sit to Stand Test (FSTS)) und das Gleichgewicht (Functional Reach Test (FR)) herausgearbeitet. Zur Überprüfung der Wirksamkeit werden in der Hauptstudie ebenfalls die Testverfahren MMST, TMT und TUG eingesetzt Der Sit to Stand Test (STS) und die Frailty and Injuries: Cooperative Studies of Intervention Techniques-4 (FICSIT) ersetzen die Testverfahren FSTS und FR. Nach Abschluss der Hauptstudie werden zudem Mitarbeitende zur selbstständigen Alltagsgestaltung der Teilnehmenden und dem benötigten Pflegeaufwand, beziehungsweise zur Implementierung des DMB befragt. Statistik: Um die Durchführbarkeit zu überprüfen werden deskriptive Statistiken sowie retrospektive Einschätzungen berichtet. Mithilfe von parametrischen (Student’s t-Test), beziehungsweise nicht-parametrischen Berechnungsverfahren (Mann-Whitney-U Test, Wilcoxon Test) werden in der Pilotstudie erste Tendenzen zur Wirksamkeit des DMB untersucht. Die Wirkung von körperlicher Aktivität auf die Leistungsfähigkeit von Personen mit Demenz wird in der Hauptstudie durch eine Per-Protocol Analyse untersucht. Mittels zweifaktorieller Varianzanalyse mit Messwiederholung, beziehungsweise parametrischen und nicht-parametrischen Analyseverfahren werden Gruppenund Zeiteffekte berechnet. Zusätzlich wird eine Subgruppenanalyse (Teilnehmende mit leichtem (N= 57), beziehungsweise mittlerem Erkrankungsgrad (N= 51)) durchgeführt. Die Befragung der Alltagsgestaltung und zum Pflegeaufwand wird jeweils über Gruppenvergleiche von IG und Kontrollgruppe (KG) ausgewertet. Die Ergebnisse zur Implementierung des Bewegungsprogramms werden deskriptiv berichtet. Stichprobe und Ergebnisse: Stichprobe: Von N= 32 geeigneten Teilnehmenden konnten N= 19 in die Pilotstudie eingeschlossen werden (IG: N= 8, MMST= 17,8 (4,0); KG: N= 11, MMSE= 17,0 (5,1). Die Teilnehmenden der IG waren im Mittel 84,2 (6,3) Jahre alt, die der KG 86,4 (3,3). N= 15 Teilnehmende wurden in die Auswertung eingeschlossen (IG: N= 6, KG: N= 9). Von N= 600 geeigneten Personen für die Hauptstudie wurden N= 344 in die Studie und N= 108 in die Per-Protocol Analyse aufgenommen (IG: N= 61, MMST= 17,9 (4,1); KG: N= 47, MMST= 17,2 (3,8)). Die Teilnehmenden waren im Mittel 83,7 (6,5) (IG) und 85,3 (5,5) (KG) Jahre alt. Für die Befragung der Mitarbeitenden wurden für die selbstständige Alltagsgestaltung und den Pflegeaufwand N= 16 von N= 36 versendeten Fragebögen ausgewertet. Für die Implementierung konnten alle rückläufigen Fragebögen in die Auswertung einbezogen werden (N= 29 von N=72). Ergebnisse: Die Durchführbarkeit des DMB kann bestätigt werden. Zudem weisen erste Tendenzen auf eine positive Wirkung des DMB auf die kognitive und motorische Leistungsfähigkeit hin. Die Ergebnisse der Hauptstudie zur Wirksamkeit des DMB ergeben für die Gesamtstichprobe und die Subgruppe mit leichtem Erkrankungsgrad keine statistisch signifikanten Zeit- und Gruppeneffekte. Die IG der Subgruppe mit mittlerem Erkrankungsgrad zeigt lediglich im TMT eine statistisch signifikante Veränderung. Sowohl im pre-post Vergleich (TMT Bearbeitungszeit: p= ,005; TMT Durchführungsqualität: p= ,022) als auch im Vergleich zur KG (TMT Bearbeitungszeit: p= ,042) fällt die IG in ihrer Leistung ab. Die selbstständige Alltagsgestaltung wird von den Befragten für die IG im Vergleich zur KG als verbessert eingeschätzt („körperliche Aktivität“: p= ,035, „geistige Aktivität“: p= ,010, „soziale Teilhabe“: p= ,009; Multi-Item Skala „selbstständige Alltagsgestaltung“: p= ,015). Der Pflegeaufwand wird für IG und KG als gleich hoch angesehen, lediglich die „Mobilität“ (p= ,036) wird in der IG in diesem Zusammenhang Im Vergleich zur KG bewertet. Diskussion und Ausblick: Die Durchführbarkeit des DMB konnte mithilfe der Pilotstudie gezeigt werden. Es ließen sich positive Tendenzen der kognitiven und motorischen Leistungsfähigkeit aufzeigen, die Überprüfung der Wirksamkeit durch die Hauptstudie konnte diese jedoch nicht bestätigen. Mögliche Gründe hierfür könnten die Heterogenität der Gesamtstichprobe sowie die daraus resultierenden, heterogenen Übungsgruppen sein. Die reduzierte Aufmerksamkeitsfähigkeit der Subgruppe mit mittelgradiger Erkrankung lässt den Schluss zu, dass das DMB durch weitere Studien noch spezifischer auf die Zielgruppe Personen mit Demenz abgestimmt werden muss (z. B. Kommunikation, Gruppengröße). Die Implementierung des DMB in den Altenpflegeeinrichtungen konnte teilweise umgesetzt werden. Für eine strukturierte und potenziell erfolgreiche Implementierung von gesundheitsbezogenen Interventionen sollten zukünftige Studien bereits zu Beginn eine Verknüpfung zum späteren Anwendungsbereich im Sinne einer transdiziplinären Herangehensweise herstellen

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

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): DERR1-10.2196/3624

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

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

Effects of a 16-week multimodal exercise program on activities of daily living in institutionalized individuals with dementia

We aimed to examine the effects of a 16-week multimodal exercise program (MEP) on activities of daily living (ADL) in individuals with dementia (IWD). Furthermore, we investigated the participants’ individual response to the MEP and whether baseline cognitive and motor performance explain ADL performance. We conducted a multicenter randomized controlled trial (RCT) involving 319 participants aged ≥ 65 years with mild to moderate dementia. ADL were assessed at baseline and after the 16-week intervention using the Barthel Index (BI), the Erlangen Test of Activities of Daily Living (E-ADL) and the 7‑item Physical Performance Test (PPT-7). We additionally assessed cognitive and motor performance using standardized and validated assessments. Intervention effects were examined through two-factor analysis of variance with repeated measurements applying a per protocol and an intention-to-treat analysis. We compared baseline cognitive and motor performance between positive-responders (positive-R), non-responders (non-R), and negative-responders (negative-R) and examined cognitive and motor performance as potential cofounders of ADL by conducting multiple regression analyses. There were no significant time×group effects on ADL. Between 20 and 32% of participants responded positively to the intervention, i.e., improved ADL performance from baseline to follow-up. Positive-R had worse baseline motor performance compared to non-R. Cognitive and motor performance explained up to 51.4% of variance in ADL. The MEP had no significant overall effect on ADL in IWD. This may be related to insufficient exercise intensity. However, our results indicate that the response to the MEP depends on individual prerequisites which should thus be considered in further research on individual exercise approaches

Effects of a 16-week multimodal exercise program on activities of daily living in institutionalized individuals with dementia: A multicenter randomized controlled trial [Auswirkungen eines 16-wöchigen multimodalen Trainingsprogramms auf die Aktivitäten des täglichen Lebens bei Heimbewohnern mit Demenz: Eine multizentrische randomisierte kontrollierte Studie]

We aimed to examine the effects of a 16-week multimodal exercise program (MEP) on activities of daily living (ADL) in individuals with dementia (IWD). Furthermore, we investigated the participants’ individual response to the MEP and whether baseline cognitive and motor performance explain ADL performance. We conducted a multicenter randomized controlled trial (RCT) involving 319 participants aged ≥ 65 years with mild to moderate dementia. ADL were assessed at baseline and after the 16-week intervention using the Barthel Index (BI), the Erlangen Test of Activities of Daily Living (E-ADL) and the 7‑item Physical Performance Test (PPT-7). We additionally assessed cognitive and motor performance using standardized and validated assessments. Intervention effects were examined through two-factor analysis of variance with repeated measurements applying a per protocol and an intention-to-treat analysis. We compared baseline cognitive and motor performance between positive-responders (positive-R), non-responders (non-R), and negative-responders (negative-R) and examined cognitive and motor performance as potential cofounders of ADL by conducting multiple regression analyses. There were no significant time×group effects on ADL. Between 20 and 32% of participants responded positively to the intervention, i.e., improved ADL performance from baseline to follow-up. Positive-R had worse baseline motor performance compared to non-R. Cognitive and motor performance explained up to 51.4% of variance in ADL. The MEP had no significant overall effect on ADL in IWD. This may be related to insufficient exercise intensity. However, our results indicate that the response to the MEP depends on individual prerequisites which should thus be considered in further research on individual exercise approaches

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

Outcome Prediction in Patients with Severe COVID-19 Requiring Extracorporeal Membrane Oxygenation—A Retrospective International Multicenter Study

The role of veno-venous extracorporeal membrane oxygenation therapy (V-V ECMO) in severe COVID-19 acute respiratory distress syndrome (ARDS) is still under debate and conclusive data from large cohorts are scarce. Furthermore, criteria for the selection of patients that benefit most from this highly invasive and resource-demanding therapy are yet to be defined. In this study, we assess survival in an international multicenter cohort of COVID-19 patients treated with V-V ECMO and evaluate the performance of several clinical scores to predict 30-day survival. Methods: This is an investigator-initiated retrospective non-interventional international multicenter registry study (NCT04405973, first registered 28 May 2020). In 127 patients treated with V-V ECMO at 15 centers in Germany, Switzerland, Italy, Belgium, and the United States, we calculated the Sequential Organ Failure Assessment (SOFA) Score, Simplified Acute Physiology Score II (SAPS II), Acute Physiology And Chronic Health Evaluation II (APACHE II) Score, Respiratory Extracorporeal Membrane Oxygenation Survival Prediction (RESP) Score, Predicting Death for Severe ARDS on V-V ECMO (PRESERVE) Score, and 30-day survival. Results: In our study cohort which enrolled 127 patients, overall 30-day survival was 54%. Median SOFA, SAPS II, APACHE II, RESP, and PRESERVE were 9, 36, 17, 1, and 4, respectively. The prognostic accuracy for all these scores (area under the receiver operating characteristic—AUROC) ranged between 0.548 and 0.605. Conclusions: The use of scores for the prediction of mortality cannot be recommended for treatment decisions in severe COVID-19 ARDS undergoing V-V ECMO; nevertheless, scoring results below or above a specific cut-off value may be considered as an additional tool in the evaluation of prognosis. Survival rates in this cohort of COVID-19 patients treated with V-V ECMO were slightly lower than those reported in non-COVID-19 ARDS patients treated with V-V ECMO