Active, Not Recruiting

NCT Number: NCT06659484

Health Data from Well on My Legs Program

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Sarcopenia Atrophy Behavior Falling Fear Frailty Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Inactivity Sedentary Behavior Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de médecine du vieillissement - Hôpital Edouard Herriot

Lyon, France, 69003

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assessment

Diagnostic Test

Evaluation carried out during a day hospital at T0 (initial assessment) and T3 (after the exercise program at around 3 months) including:

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,
Nutritional assessment :

nutritional status will also be asses

Multicomponent exercise program

Other

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.

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

Other

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.

Primary outcomes

SPPB (Short Physical Performance Battery)

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

Functional status is assessed by the overall Short Physical Performance Battery (SPPB) score, based on three components: gait speed, chair raising and balance tests.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: DS-BSSJ

Important dates

Study start: 2016
Primary completion: 2025
Study completion: 2025
First posted: Oct 26, 2024
Registry last updated: Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting