Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors (NCT05625828) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors
France176 participantsStarted 2022-09-13
Plain-language summary
The goal of this interventional study is to compare in community dwelling elderly people the effects of two physical activity programs to prevent accident falls : "SILVER XIII EQUILIBRE" program and "VIVIFRAIL" program, on several risks factors such as executive functions and functional capacities.
Participants will perform a 1 hour physical activity session during 10 weeks and effects will be measured using a multidimensional test battery. "SILVER XIII EQUILIBRE" program contains cognitive-motor exercises where participants have to perform two tasks simultaneously such as answering math questions while walking whereas "VIVIFRAIL" program contains multifactorial exercises such as walking, balance training and resistance training in single-task condition.
The main question it aims to answer is :
• Does physical activity enriched with simultaneous cognitive exercises enhances the effects ?
Who can participate
Age range
65 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:
* Older people living at home
* Able to walk without technical assistance
Exclusion Criteria:
* Presence of a proven major neurocognitive disorder (MOCA score \< 18)
* Patients with severe depression (Geriatric Depression Scale score \> 10)
* Body mass index (BMI) \> 35
* Diagnosed and known neurological or neurodegenerative pathology
* Having declared more than 3 falls in the pas year
* Presence of a motor disorder
* Contraindication to the practice of a physical or sporting activity
* Participation in another protocol for the prevention of falls or loss of autonomy in the last 6 months
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
1
Change of Trail Making Test part A and B scores at Week 12 after intervention
Timeframe: Week 1 and Week 12
2
Change of Stroop Test Victoria version scores at Week 12 after intervention
Timeframe: Week 1 and Week 12
3
Change of walking speed at Week 12 after intervention