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Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)

22. august 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Canton of Bern
      • Bern, Canton of Bern, Schweiz, 3013
        • Domicil Spitalackerpark
      • Biel/Bienne, Canton of Bern, Schweiz, 2504
        • Alterswohnheim Büttenberg Biel
    • Canton of Fribourg
      • Murten/Morat, Canton of Fribourg, Schweiz, 3280
        • Senevita Résidence Beaulieu Murten

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Andre navne:
  • Aktiv Gegen Sturzangst (AGES)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Course-leader deployment
Tidsramme: During the 8-week intervention period
Number and proportion of trained course leaders who subsequently delivered an AGES intervention group
During the 8-week intervention period
Participant retention
Tidsramme: Baseline to approximately 8 weeks
Number and proportion of enrolled participants retained through completion of the intervention
Baseline to approximately 8 weeks
Completion of clinical outcome measures
Tidsramme: Baseline and approximately 8 weeks
Number and proportion of participants providing paired FES-I, WHO-5 and TUG assessments
Baseline and approximately 8 weeks
Protocol adherence
Tidsramme: Through approximately 8 weeks
Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations
Through approximately 8 weeks
Feasibility of LiDAR gait assessment
Tidsramme: At approximately Week 8, toward the end of the 8-week intervention period
Proportion of participants in whom LiDAR measurement could be acquired and proportion of acquired measurements yielding usable processed gait data
At approximately Week 8, toward the end of the 8-week intervention period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Falls Efficacy Scale-International (FES-I)
Tidsramme: 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.
Baseline and approximately 8 weeks
World Health Organization-5 Well-Being Index (WHO-5)
Tidsramme: Baseline and approximately 8 weeks
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.
Baseline and approximately 8 weeks
Timed Up and Go (TUG) Test
Tidsramme: Baseline and approximately 8 weeks
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.
Baseline and approximately 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2022

Primær færdiggørelse (Faktiske)

31. december 2022

Studieafslutning (Faktiske)

31. december 2022

Datoer for studieregistrering

Først indsendt

19. august 2026

Først indsendt, der opfyldte QC-kriterier

22. august 2026

Først opslået (Faktiske)

26. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AGES-2021
  • 849 - Age-Stiftung Project ID (Anden identifikator: Age-Stiftung)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication of the primary study results and available for 5 years thereafter.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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