- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07809087
Feasibility Study of an Interactive Wall-Based Intervention Program for Nursing Home Residents and Patients in Long-Term Care Facilities: Mur'Aventure (MUR'AVENTURE)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Elodie Piche, PhD
- Numéro de téléphone: +33492034925
- E-mail: piche.e@chu-nice.fr
Sauvegarde des contacts de l'étude
- Nom: Assia Bebiche Lamali, MD
- Numéro de téléphone: +33492034925
- E-mail: bebiche-lamali.a@chu-nice.fr
Lieux d'étude
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Nice, France
- Chu De Nice
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Contact:
- Elodie Piche, PhD
- Numéro de téléphone: +33492034925
- E-mail: piche.e@chu-nice.fr
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Chercheur principal:
- Assia Bebiche Lamali, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Immersive Interactive Wall Exergame Program (Mur'Aventure)
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acceptability of the Mur'Aventure program assessed using the French System Usability Scale (F-SUS)
Délai: During the 12-week intervention and immediately after the intervention.
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Program adherence : predefined feasibility criteria
Délai: Throughout the 12-week intervention.
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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.
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Throughout the 12-week intervention.
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Safety of the Mur'Aventure program : predefined feasibility criteria
Délai: Throughout the 12-week intervention
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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.
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Throughout the 12-week intervention
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Intervention fidelity
Délai: Throughout the 12-week intervention
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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.
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Throughout the 12-week intervention
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Change in Montreal Cognitive Assessment (MoCA) total score
Délai: Baseline and immediately after the 12-week intervention
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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.
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Baseline and immediately after the 12-week intervention
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Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) score
Délai: Baseline and immediately after the 12-week intervention
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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
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Change in Mini-Geriatric Depression Scale (Mini-GDS) score
Délai: Baseline and immediately after the 12-week intervention.
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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.
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Change in QUALIDEM total score
Délai: Baseline and immediately after the 12-week intervention.
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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.
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Mean heart rate during intervention sessions
Délai: During each intervention session throughout the 12-week intervention.
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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.
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During each intervention session throughout the 12-week intervention.
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Cognitive stimulation during the intervention
Délai: During each intervention session throughout the 12-week intervention
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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.
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During each intervention session throughout the 12-week intervention
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Mean physical load during intervention sessions
Délai: During each intervention session throughout the 12-week intervention.
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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.
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During each intervention session throughout the 12-week intervention.
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Game engagement during the intervention
Délai: During each intervention session throughout the 12-week intervention
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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.
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During each intervention session throughout the 12-week intervention
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- [25-AOIP-06
Informations sur les médicaments et les dispositifs, documents d'étude
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