Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk

This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims: 1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences. 2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences. The study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.

NCT Number	NCT06774508
Lead Sponsor	Umeå University Collaborators: Region Västerbotten
Conditions	Accidental Falls, Postural Balance, Gait, Cognition
Enrollment	33 participants
Start Date	2025-02-17
Primary Completion	2025-09-01 (estimated)
Study Completion	2025-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-02-25