- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07787819
Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)
22 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
19
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Canton of Bern
-
Bern, Canton of Bern, Zwitserland, 3013
- Domicil Spitalackerpark
-
Biel/Bienne, Canton of Bern, Zwitserland, 2504
- Alterswohnheim Büttenberg Biel
-
-
Canton of Fribourg
-
Murten/Morat, Canton of Fribourg, Zwitserland, 3280
- Senevita Résidence Beaulieu Murten
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Course-leader deployment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Falls Efficacy Scale-International (FES-I)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 september 2022
Primaire voltooiing (Werkelijk)
31 december 2022
Studie voltooiing (Werkelijk)
31 december 2022
Studieregistratiedata
Eerst ingediend
19 augustus 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 augustus 2026
Eerst geplaatst (Werkelijk)
26 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
22 augustus 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AGES-2021
- 849 - Age-Stiftung Project ID (Andere identificatie: Age-Stiftung)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .