Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)
22 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
19
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Canton of Bern
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Bern, Canton of Bern, Suiza, 3013
- Domicil Spitalackerpark
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Biel/Bienne, Canton of Bern, Suiza, 2504
- Alterswohnheim Büttenberg Biel
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Canton of Fribourg
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Murten/Morat, Canton of Fribourg, Suiza, 3280
- Senevita Résidence Beaulieu Murten
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Course-leader deployment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Falls Efficacy Scale-International (FES-I)
Periodo de tiempo: Baseline and approximately 8 weeks
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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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2022
Finalización primaria (Actual)
31 de diciembre de 2022
Finalización del estudio (Actual)
31 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de agosto de 2026
Publicado por primera vez (Actual)
26 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AGES-2021
- 849 - Age-Stiftung Project ID (Otro identificador: Age-Stiftung)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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