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

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  2. 2 versions Re-verified since Jan 20, 2025, no change to tracked fieldsv3-v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 9, 2025 to Feb 17, 2025
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06774508
Lead Sponsor Umeå University
Collaborators: Region Västerbotten
Conditions
(from sponsor)
Accidental Falls, Postural Balance, Gait, Cognition
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov