- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07787819
Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities (AGES)
August 22, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Canton of Bern
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Bern, Canton of Bern, Switzerland, 3013
- Domicil Spitalackerpark
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Biel/Bienne, Canton of Bern, Switzerland, 2504
- Alterswohnheim Büttenberg Biel
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Canton of Fribourg
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Murten/Morat, Canton of Fribourg, Switzerland, 3280
- Senevita Résidence Beaulieu Murten
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Course-leader deployment
Time Frame: During the 8-week intervention period
|
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
Time Frame: 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
Time Frame: Baseline and approximately 8 weeks
|
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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Falls Efficacy Scale-International (FES-I)
Time Frame: 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
|
|
World Health Organization-5 Well-Being Index (WHO-5)
Time Frame: 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.
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Baseline and approximately 8 weeks
|
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Timed Up and Go (TUG) Test
Time Frame: 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.
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Baseline and approximately 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Stefan Kloeppel, MD, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
December 31, 2022
Study Registration Dates
First Submitted
August 19, 2026
First Submitted That Met QC Criteria
August 22, 2026
First Posted (Actual)
August 26, 2026
Study Record Updates
Last Update Posted (Actual)
August 26, 2026
Last Update Submitted That Met QC Criteria
August 22, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGES-2021
- 849 - Age-Stiftung Project ID (Other Identifier: Age-Stiftung)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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 Sharing Time Frame
Beginning 6 months after publication of the primary study results and available for 5 years thereafter.
IPD Sharing Access Criteria
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 Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.