NCT06774508 Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk
| NCT ID | NCT06774508 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umeå University |
| Condition | Accidental Falls |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2025-02-17 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * aged 75 years or older * moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m/s or TUG \>15 s without walking aid) * can walk independently indoors, without a walking aid * can walk 500m independently outdoors, with or without a walking aid Exclusion Criteria: * a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall) * Mini-Mental State Examination (MMSE) score \<24 or dementia diagnosis * a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)
Contact & Investigator
Annika Toots, PhD
PRINCIPAL INVESTIGATOR
Umeå University
Frequently Asked Questions
Who can join the NCT06774508 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Accidental Falls. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774508 currently recruiting?
Yes, NCT06774508 is actively recruiting participants. Contact the research team at annika.toots@umu.se for enrollment information.
Where is the NCT06774508 trial being conducted?
This trial is being conducted at Umeå, Sweden.
Who is sponsoring the NCT06774508 clinical trial?
NCT06774508 is sponsored by Umeå University. The principal investigator is Annika Toots, PhD at Umeå University. The trial plans to enroll 33 participants.