SarcopeniaDS-BSSJNCT06659484
Health Data from Well on My Legs Program
An observational study of Sarcopenia and Frailty, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Physical Inactivity
- What is being tested?
- Assessment, Multicomponent exercise program and Follow-up at T3 + 6 months and T3 + 12 months
- How many people
- 1,600 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2016to 1 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine du vieillissement - Hôpital Edouard Herriot
Lyon, France, 69003
About this study
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.
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.
- Conditions
- Sarcopenia, Frailty, Physical Inactivity, Fear, Falling
- Being tested
- Assessment, Multicomponent exercise program, Follow-up at T3 + 6 months and T3 + 12 months
- Keywords
- Older Adults, Mobility disability, prevention program, exercise, nutrition
- Medical subject headings
- Sarcopenia, Frailty, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentDiagnostic 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 programOther
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 monthsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Community-dwelling older adults assessed without mobility disability risk factors following initial | Community-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed without any mobility disability risk factors. This group is not included for intervention and received lifestyle counselling to maintain habits. No follow-up is conducted in this group.
Or community-dwelling older adults aged of >70y, screened with medical contraindication. This group is not included for intervention and oriented to other medical practitioners. No follow-up is conducted in this group. Receives: Diagnostic Test: Assessment; Other: Multicomponent exercise program; Other: Follow-up at T3 + 6 months and T3 + 12 months | |
| Community-dwelling older adults assessed with mobility disability risk factors following initial ass | Community-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor. This group is included for 3 months exercise intervention. Follow-up is conducted at 3 months (T3) and from T3 at 6 months (phone call) and 12 months. Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPPB (Short Physical Performance Battery)
Functional status is assessed by the overall Short Physical Performance Battery (SPPB) score, based on three components: gait speed, chair raising and balance tests.
Measured: Change in the SPPB Score at 3 months of intervention and 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start20 Sep 2016
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DELAIRE Leo, Kinesiologist, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659484
- Sponsor's protocol ID
- 1791
- Acronym
- DS-BSSJ
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Courtay-Breuil A, Delaire L, Humblot J, Gilbert T, Aubertin-Leheudre M, Bonnefoy M. Influence of a multicomponent exercise intervention on fear of falling and gait parameters in community-dwelling older adults: a prospective study. BMC Geriatr. 2025 Aug 28;25(1):668. doi: 10.1186/s12877-025-06257-1.
PubMed 40877763
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06659484
- Acronym / sponsor ID
- DS-BSSJ / 1791
- Conditions
- Sarcopenia, Frailty, Physical Inactivity, Fear, Falling
- Keywords
- Older Adults, Mobility disability, prevention program, exercise, nutrition
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-dwelling older adults assessed without mobility disability risk factors following initial | – | Diagnostic Test: Assessment, Other: Multicomponent exercise program, Other: Follow-up at T3 + 6 months and T3 + 12 monthsCommunity-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed without any mobility disability risk factors. This group is not included for intervention and received lifestyle counselling to maintain habits. No follow-up is conducted in this group. Or community-dwelling older adults aged of >70y, screened with medical contraindication. This group is not included for intervention and oriented to other medical practitioners. No follow-up is conducted in this group. |
| Community-dwelling older adults assessed with mobility disability risk factors following initial ass | – | Diagnostic Test: AssessmentCommunity-dwelling older adults aged of >70y, screened at risk of mobility disability risk factors and assessed with at least 1 mobility disability risk factor. This group is included for 3 months exercise intervention. Follow-up is conducted at 3 months (T3) and from T3 at 6 months (phone call) and 12 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (12 listed)
- Patient covered by the "Well on my legs" program for primary and secondary prevention of mobility disability.
- 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
Key exclusion criteria (6 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentEvaluation 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 | Diagnostic test | Community-dwelling older adults assessed with mobility disability risk factors following initial ass, Community-dwelling older adults assessed without mobility disability risk factors following initial |
| Multicomponent exercise programAfter 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 | Community-dwelling older adults assessed without mobility disability risk factors following initial |
| Follow-up at T3 + 6 months and T3 + 12 monthsFollow-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. | Other | Community-dwelling older adults assessed without mobility disability risk factors following initial |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 40877763Courtay-Breuil A, Delaire L, Humblot J, Gilbert T, Aubertin-Leheudre M, Bonnefoy M. Influence of a multicomponent exercise intervention on fear of falling and gait parameters in community-dwelling older adults: a prospective study. BMC Geriatr. 2025 Aug 28;25(1):668. doi: 10.1186/s12877-025-06257-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DELAIRE Leo, Kinesiologist principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Frailty, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPPB (Short Physical Performance Battery) (time frame: Change in the SPPB Score at 3 months of intervention and 1 year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06659484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.