High-intensity functional exercise with cognitive challenges for older adults at risk of falls
The Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People with Intermediate Risk for Falls: a Randomized Controlled Pilot Trial
This study is testing a new exercise program that combines physical activity with brain challenges to see if it helps older adults at risk of falls stay safe and active.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 1 site (Umeå) |
| Trial ID | NCT06774508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a high-intensity functional exercise program combined with cognitive challenges for older adults who are at risk of falls. It aims to assess the acceptability and safety of the program, as well as the methods used in the study, by examining recruitment, compliance, adverse events, and participant experiences. Participants will be randomized into either the intervention group or an active control group, with tailored exercise supervised by a physiotherapist. Key outcome variables will include completion rates and statistical measures for between-group differences.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 75 years or older who are at moderate risk of falling but can walk independently indoors and outdoors.
Not a fit: Patients with a high risk of falls, significant cognitive impairment, or medical conditions that limit their ability to participate in exercise will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of falls among older adults, improving their overall safety and quality of life.
How similar studies have performed: Other studies have shown promise in using combined exercise and cognitive challenges for fall prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Umeå
- Umeå University — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Annika Toots, PhD — Umeå University
- Study coordinator: Annika Toots, PhD
- Email: annika.toots@umu.se
- Phone: 0046 90 7866329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.