Fear of FallingAGESNCT07787819
Feasibility of Aktiv Gegen Sturzangst (AGES) in Assisted Living Facilities
A study testing Multicomponent fear of falling intervention in people with Fear of Falling, run by Eric Lenouvel at 3 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear of Falling
- What is being tested?
- Multicomponent fear of falling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Sep 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Domicil Spitalackerpark
Bern, Canton of Bern, 3013
Alterswohnheim Büttenberg Biel
Biel/Bienne, Canton of Bern, 2504
Senevita Résidence Beaulieu Murten
Murten/Morat, Canton of Fribourg, 3280
About this study
Official title: 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.
Read the 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.
- Conditions
- Fear of Falling
- Being tested
- Multicomponent fear of falling intervention
- Keywords
- Older adults, Assisted living, Cognitive behavioral therapy, Exercise, Fall prevention, Mobility, Gait
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent fear of falling interventionBehavioural
Also called Aktiv Gegen Sturzangst (AGES)
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.
| Study group | Role | What they receive |
|---|---|---|
| AGES Intervention | Experimental | 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. Receives: Behavioral: Multicomponent fear of falling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course-leader deployment
Number and proportion of trained course leaders who subsequently delivered an AGES intervention group
Measured: During the 8-week intervention period
Participant retention
Number and proportion of enrolled participants retained through completion of the intervention
Measured: Baseline to approximately 8 weeks
Completion of clinical outcome measures
Number and proportion of participants providing paired FES-I, WHO-5 and TUG assessments
Measured: Baseline and approximately 8 weeks
Protocol adherence
Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations
Measured: Through approximately 8 weeks
Feasibility of LiDAR gait assessment
Proportion of participants in whom LiDAR measurement could be acquired and proportion of acquired measurements yielding usable processed gait data
Measured: At approximately Week 8, toward the end of the 8-week intervention period
Secondary outcomes (3)
Falls Efficacy Scale-International (FES-I)
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.
Measured: Baseline and approximately 8 weeks
World Health Organization-5 Well-Being Index (WHO-5)
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.
Measured: Baseline and approximately 8 weeks
Timed Up and Go (TUG) Test
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.
Measured: Baseline and approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fear of FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, non-randomized pilot study in which all participants received the AGES intervention. No comparator or control group was included.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Lenouvel
- Sponsor type
- University, hospital or other
- Collaborators
- Age-Stiftung, Public Health Switzerland
- Responsible party
- Sponsor-investigator, Eric Lenouvel, University of Bern
- Investigators
- Stefan Kloeppel, MD, Study director, Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787819
- Sponsor's protocol ID
- AGES-2021
- Other IDs
- 849 - Age-Stiftung Project ID
- Acronym
- AGES
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37965937Lenouvel 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.
PubMed 34590162
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Assisted Living Facilities: A Pilot Study
- ClinicalTrials.gov ID
- NCT07787819
- Acronym / sponsor ID
- AGES / AGES-2021
- Conditions
- Fear of Falling
- Keywords
- Older adults, Assisted living, Cognitive behavioral therapy, Exercise, Fall prevention, Mobility, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Eric LenouvelUniversity, hospital or other
- Collaborators
- Age-Stiftung, Public Health Switzerland
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, non-randomized pilot study in which all participants received the AGES intervention. No comparator or control group was included.
| Arm | Type | Receives |
|---|---|---|
| AGES Intervention | Experimental | Behavioral: Multicomponent fear of falling interventionParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent fear of falling interventionAlso: Aktiv Gegen Sturzangst (AGES)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. | Behavioural | AGES Intervention |
Primary outcome
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
Participant retention
Time frame: Baseline to approximately 8 weeks
Number and proportion of enrolled participants retained through completion of the intervention
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
Protocol adherence
Time frame: Through approximately 8 weeks
Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations
Feasibility of LiDAR gait assessment
Time frame: 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
3 secondary outcomes
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline and approximately 8 weeks
World Health Organization-5 Well-Being Index (WHO-5)
Time frame: Baseline and approximately 8 weeks
Timed Up and Go (TUG) Test
Time frame: Baseline and approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 37965937Lenouvel 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.
- Background: PubMed 34590162Lenouvel 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.
- Age-Stiftung project page for Aktiv Gegen Sturzangst (AGES), including project description and documentationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Kloeppel, MD study director
Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent fear of falling intervention in people with Fear of Falling, run by Eric Lenouvel at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course-leader deployment (time frame: During the 8-week intervention period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.