Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)
22 août 2026 mis à jour par: Eric Lenouvel
A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Assisted Living Facilities: A Pilot Study
Aktiv Gegen Sturzangst (AGES) is a multicomponent group intervention combining cognitive behavioral therapy and structured exercise to address fear of falling in older adults receiving services from assisted living facilities.
This single-arm, non-randomized pilot study evaluated the feasibility of implementing AGES in three assisted living facilities in Switzerland and the feasibility of study procedures and outcome measures for a future controlled trial.
Nineteen older adults participated in eight weekly group sessions delivered by trained course leaders.
Feasibility outcomes included recruitment, retention, course-leader deployment, protocol adherence, completion of clinical outcome measures, and feasibility of contactless LiDAR-based gait assessment.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
AGES was developed as an adaptation of multicomponent approaches to fear of falling for use in German-speaking Swiss assisted living facilities.
The intervention consisted of eight weekly group sessions of approximately 60 minutes combining cognitive behavioral therapy-based discussion and reflection with structured balance, strength, mobility, and flexibility exercises.
Sessions were delivered by trained facility-based course leaders.
The pilot primarily assessed the feasibility of recruitment and retention, course-leader training and deployment, intervention delivery, completion of proposed outcome measures, and LiDAR-based gait assessment.
Clinical measures included the Falls Efficacy Scale-International (FES-I), World Health Organization-5 Well-Being Index (WHO-5), and Timed Up and Go test (TUG).
The study was exploratory and was not designed or powered to establish intervention effectiveness.
Type d'étude
Interventionnel
Inscription (Réel)
19
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Canton of Bern
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Bern, Canton of Bern, Suisse, 3013
- Domicil Spitalackerpark
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Biel/Bienne, Canton of Bern, Suisse, 2504
- Alterswohnheim Büttenberg Biel
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Canton of Fribourg
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Murten/Morat, Canton of Fribourg, Suisse, 3280
- Senevita Résidence Beaulieu Murten
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Age 65 years or older
- Receiving some level of care or services through a participating assisted living facility
- Identified by facility staff as potentially experiencing fear of falling or expressing interest in a fall-prevention program
- Able to participate safely in group sessions
Exclusion Criteria:
- Moderate to severe neurocognitive disorder
- Unstable psychiatric illness, including an acute depressive episode or substance use disorder
- Physical limitations precluding safe participation in group sessions, including blindness, severe frailty, wheelchair dependence, or requirement for full mobility assistance
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- 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: AGES Intervention
Participants received the AGES intervention, consisting of eight weekly approximately 60-minute group sessions combining cognitive behavioral therapy-based components with structured physical exercises targeting balance, strength, mobility, and flexibility.
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Eight weekly group sessions delivered by trained course leaders.
Sessions included cognitive behavioral therapy-based discussion and reflection addressing emotions, automatic thoughts, safety behaviors, assumptions, goal setting, and self-management, combined with structured exercises performed in seated or supported-standing positions where appropriate.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Course-leader deployment
Délai: During the 8-week intervention period
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Number and proportion of trained course leaders who subsequently delivered an AGES intervention group
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During the 8-week intervention period
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Participant retention
Délai: Baseline to approximately 8 weeks
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Number and proportion of enrolled participants retained through completion of the intervention
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Baseline to approximately 8 weeks
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Completion of clinical outcome measures
Délai: Baseline and approximately 8 weeks
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Number and proportion of participants providing paired FES-I, WHO-5 and TUG assessments
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Baseline and approximately 8 weeks
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Protocol adherence
Délai: Through approximately 8 weeks
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Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations
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Through approximately 8 weeks
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Feasibility of LiDAR gait assessment
Délai: At approximately Week 8, toward the end of the 8-week intervention period
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Proportion of participants in whom LiDAR measurement could be acquired and proportion of acquired measurements yielding usable processed gait data
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At approximately Week 8, toward the end of the 8-week intervention period
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Falls Efficacy Scale-International (FES-I)
Délai: Baseline and approximately 8 weeks
|
The Falls Efficacy Scale-International (FES-I) is a 16-item questionnaire assessing concern about falling during physical and social activities.
Each item is scored from 1 (not at all concerned) to 4 (very concerned), giving a total score ranging from 16 to 64.
Higher scores indicate greater concern about falling and therefore a worse outcome.
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Baseline and approximately 8 weeks
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World Health Organization-5 Well-Being Index (WHO-5)
Délai: Baseline and approximately 8 weeks
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The World Health Organization-5 Well-Being Index (WHO-5) is a 5-item questionnaire assessing subjective psychological well-being over the previous two weeks.
Each item is scored from 0 (at no time) to 5 (all of the time), giving a total raw score ranging from 0 to 25.
Higher scores indicate greater psychological well-being and therefore a better outcome.
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Baseline and approximately 8 weeks
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Timed Up and Go (TUG) Test
Délai: Baseline and approximately 8 weeks
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The Timed Up and Go (TUG) test assesses functional mobility.
Participants are timed, in seconds, while standing up from a chair, walking 3 meters, turning, walking back, and sitting down.
The outcome is the time required to complete the test.
Lower times indicate better functional mobility, whereas higher times indicate worse mobility.
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Baseline and approximately 8 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Lenouvel E, Ullrich P, Siemens W, Dallmeier D, Denkinger M, Kienle G, Zijlstra GAR, Hauer K, Kloppel S. Cognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community. Cochrane Database Syst Rev. 2023 Nov 15;11(11):CD014666. doi: 10.1002/14651858.CD014666.pub2.
- Lenouvel E, Novak L, Biedermann A, Kressig RW, Kloppel S. Preventive treatment options for fear of falling within the Swiss healthcare system : A position paper. Z Gerontol Geriatr. 2022 Nov;55(7):597-602. doi: 10.1007/s00391-021-01957-w. Epub 2021 Sep 29.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 septembre 2022
Achèvement primaire (Réel)
31 décembre 2022
Achèvement de l'étude (Réel)
31 décembre 2022
Dates d'inscription aux études
Première soumission
19 août 2026
Première soumission répondant aux critères de contrôle qualité
22 août 2026
Première publication (Réel)
26 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AGES-2021
- 849 - Age-Stiftung Project ID (Autre identifiant: Age-Stiftung)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual participant data underlying the results reported in the primary publication may be made available to qualified researchers upon reasonable request, subject to institutional approval, ethical and data-protection requirements, and assessment of the risk of participant re-identification.
Délai de partage IPD
Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
Critères d'accès au partage IPD
Requests will be considered from qualified researchers submitting a scientifically sound proposal.
Access will be subject to review by the study investigators and, where required, the responsible institution or ethics body.
Data will be shared only where compatible with participant consent, applicable data-protection requirements, and an acceptable risk of re-identification.
A data-use agreement may be required.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .