NCT07787819

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 19, 2026

Last Update Submit

August 22, 2026

Conditions

Keywords

Older adultsAssisted livingCognitive behavioral therapyExerciseFall preventionMobilityGait

Outcome Measures

Primary Outcomes (5)

  • Course-leader deployment

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

    During the 8-week intervention period

  • Participant retention

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

    Baseline to approximately 8 weeks

  • Completion of clinical outcome measures

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

    Baseline and approximately 8 weeks

  • Protocol adherence

    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

    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

Secondary Outcomes (3)

  • Falls Efficacy Scale-International (FES-I)

    Baseline and approximately 8 weeks

  • World Health Organization-5 Well-Being Index (WHO-5)

    Baseline and approximately 8 weeks

  • Timed Up and Go (TUG) Test

    Baseline and approximately 8 weeks

Study Arms (1)

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.

Behavioral: Multicomponent fear of falling intervention

Interventions

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)
AGES Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Domicil Spitalackerpark

Bern, Canton of Bern, 3013, Switzerland

Location

Alterswohnheim Büttenberg Biel

Biel/Bienne, Canton of Bern, 2504, Switzerland

Location

Senevita Résidence Beaulieu Murten

Murten/Morat, Canton of Fribourg, 3280, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 37965937BACKGROUND
  • 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.

    PMID: 34590162BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stefan Kloeppel, MD

    Department of Old Age Psychiatry and Psychotherapy, University Hospital of Psychiatry (UPZ), Bern

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking was used. Participants, course leaders, and investigators were aware that all participants received the AGES intervention.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single-group, non-randomized pilot study in which all participants received the AGES intervention. No comparator or control group was included.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Physician and Privatdozent, Department of Old Age Psychiatry and Psychotherapy

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 26, 2026

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations