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Feasibility Study of an Interactive Wall-Based Intervention Program for Nursing Home Residents and Patients in Long-Term Care Facilities: Mur'Aventure (MUR'AVENTURE)

7 września 2026 zaktualizowane przez: Centre Hospitalier Universitaire de Nice
This prospective, single-arm feasibility study aims to evaluate the feasibility of a 12-week immersive exergame program using an interactive wall in older adults living in nursing homes (EHPAD) or long-term care units (USLD). Exergames are interactive digital games that integrate physical activity into gameplay, requiring users to perform whole-body movements to achieve game objectives while promoting exercise and energy expenditure. Participants will complete two supervised 40-minute sessions per week over 12 weeks. The primary objective is to assess feasibility through acceptability, adherence, and safety. Secondary objectives include evaluating implementation fidelity, preliminary effects on cognition, quality of life and well-being, and characterizing the physical and cognitive demands of the interactive games. Data will include usability and enjoyment questionnaires, attendance, adverse events, heart rate monitoring, cognitive performance (MoCA), quality of life (EQ-5D-5L), psychological well-being (Mini-GDS and QUALIDEM), and game performance. The results will inform the design of a future larger-scale effectiveness trial of immersive exergaming in institutionalized older adults.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

25

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Francja
      • Nice, Francja
        • Chu De Nice
        • Kontakt:
        • Główny śledczy:
          • Assia Bebiche Lamali, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Adults aged 65 years or older.
  • Resident of a nursing home (EHPAD) or long-term care unit (USLD).
  • Affiliated with the French national health insurance system.
  • Able to participate in low-to-moderate intensity adapted physical activity.
  • No cognitive impairment or mild-to-moderate cognitive impairment compatible with understanding simple instructions (MoCA >18 and physician approval).
  • Written informed consent provided by the participant or legal representative.

Exclusion Criteria:

  • Medical contraindication to adapted physical activity.
  • Severe neurological or psychiatric disorder incompatible with safe participation.
  • Severe uncorrected visual, auditory or sensory impairment preventing interaction with the immersive wall.
  • Inability to understand instructions despite adaptation.
  • Participation in another interventional study that may interfere with study outcomes.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Immersive Interactive Wall Exergame Program (Mur'Aventure)
Behawioralne: Immersive Interactive Wall Exergame Program
Participants will complete a supervised 12-week adapted physical activity program delivered through an immersive interactive wall (NeoXperience). Sessions will be performed twice weekly in groups of four participants and will last approximately 40 minutes, including a warm-up. Games are adapted to participants' physical and cognitive abilities and combine cognitive stimulation with whole-body movements. Heart rate, physical activity intensity, game performance, perceived exertion, fatigue and enjoyment will be monitored throughout the intervention.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Acceptability of the Mur'Aventure program assessed using the French System Usability Scale (F-SUS)
Ramy czasowe: During the 12-week intervention and immediately after the intervention.

Acceptability will be assessed using the French version of the System Usability Scale (F-SUS), a validated 10-item questionnaire evaluating the perceived usability of a system. Total scores range from 0 to 100, with higher scores indicating greater usability and acceptability. Acceptability will be considered achieved if at least 70% of participants obtain a score >70.

Feasibility will be considered successful if all three predefined feasibility criteria (acceptability, adherence, and safety) are met. If one or more criteria are not met, the feasibility of the intervention will be interpreted in light of the unmet criterion(ia), and potential modifications to the intervention or study procedures will be discussed.
During the 12-week intervention and immediately after the intervention.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Program adherence : predefined feasibility criteria
Ramy czasowe: Throughout the 12-week intervention.
Adherence will be evaluated by the completion rate, defined as the proportion of participants completing the entire 12-week intervention. Adherence will be considered good if the completion rate is ≥70%. Attendance rate and dropout rate will also be reported descriptively.
Throughout the 12-week intervention.
Safety of the Mur'Aventure program : predefined feasibility criteria
Ramy czasowe: Throughout the 12-week intervention
Safety will be assessed by recording the occurrence of serious adverse events (SAEs) throughout the intervention. Safety will be considered acceptable if no serious adverse events related to the intervention occur. Additional descriptive safety measures include perceived fatigue, perceived exertion, and heart rate responses recorded during each intervention session.
Throughout the 12-week intervention
Intervention fidelity
Ramy czasowe: Throughout the 12-week intervention
To describe the fidelity of program implementation, assessed by the proportion of intervention sessions delivered according to the planned protocol Intervention fidelity will be assessed as the percentage of planned exercise sessions completed according to the study protocol. Higher percentages indicate greater fidelity to the intervention.
Throughout the 12-week intervention
Change in Montreal Cognitive Assessment (MoCA) total score
Ramy czasowe: Baseline and immediately after the 12-week intervention
To explore the preliminary effects of the program on cognitive function, assessed by the change in the Montreal Cognitive Assessment (MoCA) total score Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA), a validated 30-point cognitive screening instrument evaluating memory, executive function, attention, language, visuospatial abilities, abstraction, and orientation. Scores range from 0 to 30, with higher scores indicating better cognitive function. The outcome is the change in total score between baseline and the end of the intervention.
Baseline and immediately after the 12-week intervention
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score
Ramy czasowe: Baseline and immediately after the 12-week intervention

To explore the preliminary effects of the program on health-related quality of life, assessed by the change in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) score from baseline to post-intervention.

Health-related quality of life will be assessed using the EQ-5D-5L questionnaire, which evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression across five severity levels. Responses are converted into an EQ-5D index value, with higher index values indicating better health-related quality of life. The change in EQ-5D index score between baseline and the end of the intervention will be analyzed
Baseline and immediately after the 12-week intervention
Change in Mini-Geriatric Depression Scale (Mini-GDS) score
Ramy czasowe: Baseline and immediately after the 12-week intervention.

To explore the preliminary effects of the program on self-reported psychological well-being, assessed by the change in the 4-item Mini-Geriatric Depression Scale (Mini-GDS) score from baseline to post-intervention.

Psychological well-being will be assessed using the 4-item Mini-Geriatric Depression Scale (Mini-GDS). Scores range from 0 to 4, with higher scores indicating more depressive symptoms and poorer psychological well-being. The outcome is the change in total score between baseline and the end of the intervention
Baseline and immediately after the 12-week intervention.
Change in QUALIDEM total score
Ramy czasowe: Baseline and immediately after the 12-week intervention.

To explore the preliminary effects of the program on caregiver-observed well-being, assessed by the change in the French version of the QUALIDEM total score from baseline to post-intervention.

Observed well-being will be assessed using the French version of the QUALIDEM questionnaire, a proxy-rated instrument evaluating quality of life in older adults with cognitive impairment.

Higher score indicating better quality of life. The outcome is the change in total score between baseline and the end of the intervention.
Baseline and immediately after the 12-week intervention.
Mean heart rate during intervention sessions
Ramy czasowe: During each intervention session throughout the 12-week intervention.
To describe the physical stimulation induced by the intervention sessions, assessed using heart rate and measured during each session with the Polar Unite wearable device Heart rate will be continuously recorded during each exercise session using a Polar Unite heart rate monitor. Mean heart rate (beats per minute) as well as maximal heart rate will be calculated for each participant during each session. Higher values indicate greater cardiovascular response to exercise.
During each intervention session throughout the 12-week intervention.
Cognitive stimulation during the intervention
Ramy czasowe: During each intervention session throughout the 12-week intervention
To describe cognitive stimulation during the intervention, assessed using the game score, number of errors, and completion time automatically recorded during each session Cognitive stimulation will be assessed using the total score, number of errors and completion time automatically recorded by the Mur'Aventure interactive wall software during each exercise session. Higher scores indicate better cognitive stimulation.
During each intervention session throughout the 12-week intervention
Mean physical load during intervention sessions
Ramy czasowe: During each intervention session throughout the 12-week intervention.
To describe the physical stimulation induced by the intervention sessions, assessed using heart rate and physical load measured during each session with the Polar Unite wearable device Physical load will be estimated using the Polar Unite wearable device. The device provides a proprietary estimate of exercise load based on heart rate and movement data recorded during each session. Higher values indicate greater physical exercise load.
During each intervention session throughout the 12-week intervention.
Game engagement during the intervention
Ramy czasowe: During each intervention session throughout the 12-week intervention
To describe game engagement during the intervention, assessed using the game score, number of errors, and completion time automatically recorded during each session Game engagement will be assessed using the total score, number of errors and completion time automatically recorded by the Mur'Aventure interactive wall software during each exercise session. Higher scores indicate better game performance.
During each intervention session throughout the 12-week intervention

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Centre Hospitalier Universitaire de Nice

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 października 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

23 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2026

Pierwszy wysłany (Rzeczywisty)

9 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • [25-AOIP-06

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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