RecruitingNot Applicable

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

Sweden33 participantsStarted 2025-02-17

Plain-language 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.

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment

Timeframe: Before intervention start

Adherence

Timeframe: Through the 3-month intervention

Exercise intervention content and delivery

Timeframe: Through the 3-month intervention

Retention

Timeframe: Through the 3-month intervention

Safety

Timeframe: Through the 3-month intervention period

Balance and gait capacity

Timeframe: Baseline, 3 months

Balance and gait capacity

Timeframe: Baseline, 3 months

Balance and gait capacity

Timeframe: Baseline, 3 months

Trial details

NCT IDNCT06774508

SponsorUmeå University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Annika Toots, PhD

0046 90 7866329 annika.toots@umu.se

View on ClinicalTrials.gov More Accidental Falls trials

Plain-language summary

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Recruitment

Timeframe: Before intervention start

Adherence

Timeframe: Through the 3-month intervention

Exercise intervention content and delivery

Timeframe: Through the 3-month intervention

Retention

Timeframe: Through the 3-month intervention

Safety

Timeframe: Through the 3-month intervention period

Balance and gait capacity

Timeframe: Baseline, 3 months

Balance and gait capacity

Timeframe: Baseline, 3 months

Balance and gait capacity

Timeframe: Baseline, 3 months