Active — Not RecruitingNot Applicable

Health Data from Well on My Legs Program

France1,600 participantsStarted 2016-09-20

Plain-language summary

The percentage of people aged over 80 will double in 25 years, reaching 10% of the population. This means that care practices for older adults will have to be adapted. Furthermore, disability-free life expectancy at 65 years old is 10.4 years, well below the overall life expectancy of 24.4 years for women and 19.1 years for men. Beneficiaries of the personalized autonomy allowance would increase by 60%, representing a major cost. Among the various factors predictive of loss of autonomy, loss of mobility and muscle weakness are major components (OR = 3.28 at 3 years) according to data from the latest meta-analyses. These two disability-causing factors are also responsible for multiple adverse events (falls, fractures, etc.), impaired quality of life and increased mortality. The only components accessible to preventive action and with a proven track record are exercise and nutrition. Despite a high level of evidence on the improvement of physical abilities and muscle strength, these programs are still not sufficiently implemented in practice. Indeed, neither the identification of seniors at risk of mobility disability, nor preventive actions are usually carried out in primary care. Setting up a care path, with personalized intervention combining, after identification, learning of good physical activity practices by a specialized kinesiologist and nutritional advice, followed by supervised exercise, for subjects at risk, is a public health imperative. The "Well on my legs" prevention program, supported by Hospices Civils de Lyon and present since 2014 in the Rhône region, is a concrete solution to this major public health challenge. Analyses will be based on data collected through participant assessments during the "Well on my legs" prevention program. The analyses will make it possible to assess the risk factors of mobility disability in older adults at the start (T0) and at the end of the program (T3+12months), with the aim of improving the program's efficiency and evaluating its effectiveness.

Who can participate

Age range

70 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: * Patient covered by the "Well on my legs" program for primary and secondary prevention of mobility disability. At least 1 of the following signs: * Difficulty carrying a loaded shopping basket (load approx. 4.5 kg) * Difficulty getting up from a chair without using arms * Difficulty climbing a flight of stairs (10 steps) * Difficulty moving around * Slow gait speed * Difficulty walking more than 400 meters without stopping * Walking time \< 30 min/d * Fatigue during modest physical effort: shopping, housework, * Fear of falling and/or at least one fall in the past year * Recent involuntary weight loss: weight loss ≥ 5% in 1 month or BMI \< 22kg/m2 Exclusion Criteria: * \- Patient who has not given consent to participate * Patient under guardianship or legal protection in retrospective phase * Patient with a locomotor handicap or SPPB \<5 * Patient with a life expectancy of less than 12 months * Patient with severe cognitive impairment * Patient with exercise contraindications

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

SPPB (Short Physical Performance Battery)

Timeframe: Change in the SPPB Score at 3 months of intervention and 1 year after

Trial details

NCT IDNCT06659484

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Sarcopenia trials