Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06659484

Health Data from Well on My Legs Program

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1600

Start Date

2016-09-20

Completion Date

2025-05-01

Last Updated

2024-10-26

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Assessment

Evaluation carried out during a day hospital at T0 (initial assessment) and T3 (after the exercise program at around 3 months) including: 1. Clinical assessment by a geriatrician * Medical history; systematic search for symptomatic elements (asthenia, anorexia, weight loss); research into antecedents (chronic pathologies, etc.), treatments, lifestyle, eating habits, sedentary lifestyle, * Complete clinical examination: particularly of the musculoskeletal system, morphological data (weight and height, calf circumference), analysis of risk of falls, * Current medical treatments * Autonomy for basic activities (ADL), instrumental activities of daily living (IADL), visual disorders, hearing impairment, etc. * Assessment of comorbidities (Charlson score) * Screening for sarcopenia (using the SARC-F questionnaire), * An inventory of falls and their traumatic consequences, * Assessment of frailty status using FRIED criteria, 2. Nutritional assessment : * nutritional status will also be asses

OTHER

Multicomponent exercise program

After inclusion in the protocol, participants with mobility disability risk factors are assigned to specialized and experienced kinesiologists at the end of the medical consultation. Patients will be invited to take part in group-based exercise sessions, in small groups of no more than 10 patients, under the supervision of a kinesiologist. There will be 20 sessions over 10 weeks, at a rate of 2 sessions per week, each lasting one hour. The Multicomponent exercise program included progressive resistance and balance training.

OTHER

Follow-up at T3 + 6 months and T3 + 12 months

Follow-up at T3 + 6 months : \- After the T3 visit, patients will either be redirected to independent practice (booklet) or to relay structures. At T3 + 6 months (6 months after the 3-month visit), the kinesiologists will call each patient to assess their compliance with the program, any difficulties encountered, any falls (and their severity and consequences), fear of falling, their level of ADL/IADL autonomy, level of PA practice (RAPA), presence of frailty appreciation (FRIED), whether or not they have entered an institution. Follow-up at T3 + 12 months : At T3+12 months (12 months after the 3-month visit), patients will be seen again by the kinesiologists to make a final assessment of their physical and functional conditions, with measurements (Handgrip, SPPB, TUG, gait parameters, leg strength) and questionnaires (SarQol and FES-I). Patients will only be seen again by the kinesilogists, as this is mainly a check-up and final advice visit, to continue the exercises performed since.

Locations (1)

Service de médecine du vieillissement - Hôpital Edouard Herriot

Lyon, France, France