ClinicalTrials.gg
CompletedNCT07787819AGESUpdated Aug 26, 2026

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

An interventional study of Multicomponent fear of falling intervention in Fear of Falling, sponsored by Eric Lenouvel. Completed at 3 sites in Switzerland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Eric Lenouvel · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 11 months after the study started (first participant enrolled Sep 2022, registered Aug 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 143 studies in Motor Activity with a site in Switzerland — 24 open to participants now, 25 under way, none of them phase 3. Motor Activity · Switzerland.

Enrollment
98th of 110
19 · median 60
Started
2022
with 13 others
No phase
102 of 143
17 open now
Registered
142nd of 143
by date

Among the 143 studies in Motor Activity with a site in Switzerland, this one is the 98th largest by enrollment of the 110 interventional ones that give a count, is one of 14 that started in 2022, is one of 102 with no phase, and was the 142nd registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

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Open to participants now

24 of the 143 studies in Motor Activity with a site in Switzerland are open now. Recruiting first, the newest first:

19 more — sign in →

All 24 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 65 Years and older · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • Fear of Falling

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Keywords

  • Older adults
  • Assisted living
  • Cognitive behavioral therapy
  • Exercise
  • Fall prevention
  • Mobility
  • Gait
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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.

    Behavioral: Multicomponent fear of falling intervention

Interventions

  • BehavioralMulticomponent fear of falling intervention

    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.

    Also known as: Aktiv Gegen Sturzangst (AGES)

06

What researchers measure

Primary outcomes

  1. Course-leader deployment

    Number and proportion of trained course leaders who subsequently delivered an AGES intervention group

    Time frame: During the 8-week intervention period

  2. Participant retention

    Number and proportion of enrolled participants retained through completion of the intervention

    Time frame: Baseline to approximately 8 weeks

  3. Completion of clinical outcome measures

    Number and proportion of participants providing paired FES-I, WHO-5 and TUG assessments

    Time frame: Baseline and approximately 8 weeks

  4. Protocol adherence

    Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations

    Time frame: Through approximately 8 weeks

  5. 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

    Time frame: At approximately Week 8, toward the end of the 8-week intervention period

Secondary outcomes

  1. 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.

    Time frame: Baseline and approximately 8 weeks

  2. 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.

    Time frame: Baseline and approximately 8 weeks

  3. 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.

    Time frame: Baseline and approximately 8 weeks

07

Study locations

3 sites
  • Domicil Spitalackerpark
    Bern, Canton of Bern 3013, Switzerland
  • Alterswohnheim Büttenberg Biel
    Biel/Bienne, Canton of Bern 2504, Switzerland
  • Senevita Résidence Beaulieu Murten
    Murten/Morat, Canton of Fribourg 3280, Switzerland
08

References and documents

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 37965937 ↗
  • 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. PubMed 34590162 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

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

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Dec 2022, 3 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 3 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 26, 2026
StartActual
Sep 1, 2022
Primary completionActual
Dec 31, 2022
CompletionActual
Dec 31, 2022
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07787819
Lead sponsor
Eric Lenouvel
Collaborators
Age-Stiftung, Public Health Switzerland
Responsible party
Eric Lenouvel (Senior Physician and Privatdozent, Department of Old Age Psychiatry and Psychotherapy, University of Bern) — Sponsor-investigator
First posted
Aug 26, 2026
Start date
Sep 1, 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Aug 26, 2026

Study contacts

Stefan Kloeppel, MD
study director · Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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