NCT Number: NCT07787819
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Domicil Spitalackerpark, Bern, Canton of Bern, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Aktiv Gegen Sturzangst (AGES)
Time frame: During the 8-week intervention period
Number and proportion of trained course leaders who subsequently delivered an AGES intervention group
Time frame: Baseline to approximately 8 weeks
Number and proportion of enrolled participants retained through completion of the intervention
Time frame: Baseline and approximately 8 weeks
Number and proportion of participants providing paired FES-I, WHO-5 and TUG assessments
Time frame: Through approximately 8 weeks
Number of delivering course leaders reporting delivery according to the standardized intervention manual without major deviations
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
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.
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.
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.
Eric Lenouvel
Other
A Cognitive-Behavioral and Exercise Intervention to Reduce Fear of Falling in Older Adults in Assisted Living Facilities: A Pilot Study
Acronym: AGES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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