Clinical trial NCT06659484: Health Data from Well on My Legs Program
Official title: Evaluation and Changes of Disability Mobility Risk Factors in Older Adults Aged 70 and Over and Integrated in "Well on My Legs" Prevention Program.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sarcopenia
Frailty
Physical Inactivity
Fear
Falling
Keywords: Older Adults
Mobility disability
prevention program
exercise
nutrition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 1600
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling older adults aged 70 and over, living at home, presenting risk factors for loss of mobility and having been assessed in the "Well on my legs" program for, at least, initial assessment (T0).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: SPPB (Short Physical Performance Battery)
timeFrame: Change in the SPPB Score at 3 months of intervention and 1 year after
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de médecine du vieillissement - Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: DELAIRE Leo, Kinesiologist
role: PRINCIPAL_INVESTIGATOR
References: