NCT06659484: DS-BSSJ

Health Data from Well on My Legs Program

Active, enrolled Last updated 26 October 2024

What this trial tests

trial testing Assessment in Sarcopenia in 1,600 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 September 2016

Primary endpoint
1 May 2025

1 May 2025

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,600
Start date	20 September 2016
Primary completion	1 May 2025
Estimated completion	1 May 2025
Sites	1 location across France

Drugs / interventions tested

• Assessment
• Multicomponent exercise program
• Follow-up at T3 + 6 months and T3 + 12 months

Conditions studied

• Sarcopenia — all drugs for Sarcopenia →
• Frailty — all drugs for Frailty →
• Physical Inactivity — all drugs for Physical Inactivity →
• Fear — all drugs for Fear →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

70 and older, any sex, with Sarcopenia or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Influence of a multicomponent exercise intervention on fear of falling and gait parameters in community-dwelling older adults: a prospective study.
   Courtay-Breuil A, Delaire L, Humblot J, Gilbert T, et al · · 2025 · PMID 40877763 · DOI 10.1186/s12877-025-06257-1