Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)
22 de agosto de 2026 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
19
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Canton of Bern
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Bern, Canton of Bern, Suíça, 3013
- Domicil Spitalackerpark
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Biel/Bienne, Canton of Bern, Suíça, 2504
- Alterswohnheim Büttenberg Biel
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Canton of Fribourg
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Murten/Morat, Canton of Fribourg, Suíça, 3280
- Senevita Résidence Beaulieu Murten
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Course-leader deployment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Falls Efficacy Scale-International (FES-I)
Prazo: 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)
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2022
Conclusão Primária (Real)
31 de dezembro de 2022
Conclusão do estudo (Real)
31 de dezembro de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
19 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de agosto de 2026
Primeira postagem (Real)
26 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AGES-2021
- 849 - Age-Stiftung Project ID (Outro identificador: Age-Stiftung)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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