Mobility LimitationPREPANCT03667664
PREPA PREvention of Loss of Autonomy
A study testing Multidimensional assessments, Multicomponent group-based and supervised exercise program and Follow-up at T3 + 6 months and T3 + 12 months in people with Mobility Limitation and Physical Activity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
According to several reports, the proportion of people aged 80yrs or older will be doubled within the next 25y, reaching 10% of the global population. Furthermore, the health life expectancy at 65y is 10.4y which remains much lower than the general life expectancy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mobility Limitation, Physical Activity
- What is being tested?
- Multidimensional assessments, Multicomponent group-based and supervised exercise program and Follow-up at T3 + 6 months and T3 + 12 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2018to Oct 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient eligible for the "mobility loss prevention" program
- At least one of the following signs:
- Difficulty carrying a loaded shopping basket (about 4.5 kg)
- Difficulty rising from a chair without using the arms
- Difficulty climbing one flight of stairs (10 steps)
- Difficulty moving around
Show all 11Show fewer
- Slowed walking
- Difficulty walking more than 400 meters without stopping
- Walking time < 30 minutes/day
- Fatigue during mild physical efforts: running errands, household chores; fear of falling and/or at least one fall in the past year
- Recent unintentional weight loss: weight loss ≥ 5% in 6 months or BMI < 22 kg/m²
Who cannot join
- Patient who has not given consent to participate
- Patient under guardianship in retrospective phase
- Locomotor disability
- expectancy of life being under 12 months
- BMI ≥ 35 Kg/m2
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Gériatrique Groupement Hospitalier Sud
Pierre-Bénite, 69495
About this study
Official title: Prevention Study on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to Old People.
According to several reports, the proportion of people aged 80yrs or older will be doubled within the next 25y, reaching 10% of the global population. Furthermore, the health life expectancy at 65y is 10.4y which remains much lower than the general life expectancy. As a result, there is a constant need of developing preventive strategies through multimodal programs.
Among the predictive factors of mobility disability with age, muscular weakness and decreased physical function are major components. These two factors are known of being responsible for falls and fractures that lead to decrease the quality of life and an increase in mortality.
Read more
Exercise and nutrition are the only components that have proven their efficacy to struggle mobility disability risk. It is important to integrate these two components in a sustained intervention within a multidimensional prevention program. However, there is a lack of implementation of these programs in primary care.
Indeed, neither the screening of older adults at risk of mobility disability, nor the preventive actions are usually implemented for this population. The implementation of a prevention care pathway, with personalized intervention and a sustained follow-up, along with supervised exercise training combined with nutritional counselling, is the public health imperatives.
Based on prevention care pathway that designed for community-dwelling older adults screened at risk of mobility disability. The purpose of this open cohort study was to highlight the efficacy and the feasibility of a multimodal program implemented on real-life setting specifically on the physical function and risk of mobility loss, along with their maintenance at 6-months and 1-year follow-up.
- Conditions
- Mobility Limitation, Physical Activity
- Being tested
- Multidimensional assessments, Multicomponent group-based and supervised exercise program, Follow-up at T3 + 6 months and T3 + 12 months
- Keywords
- Autonomy, Elderly, Physical exercise, Nutrition, Prevention
- Medical subject headings
- Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional assessmentsDiagnostic test
Evaluation carried out during a day hospital at T0 (initial assessment) and T3 following the exercise program including:
- Clinical assessment by a geriatrician
- Nutritional assessment
- Physical capacity assessment
Following initial assessment (T0), older adults are included in the multicomponent exercise program if they present mobility disability risk factors including :
- At least pre-frailty regarding Fried frailty criteria AND/OR
- At least probable sarcopenia regarding EWGSOP2 algorithm AND/OR
- The presence of at least an intermediate fall risk AND/OR
- The presence of a fear of falling Following the exercise program (T3), all participants are re-assessed in the same way as T0. Investigators then set goals in physical activity with participants to maintain benefits and foster self-engagement in an healthy lifestyle. Additionnally, participants are orientated to exercise facilities and received an individualized booklet of exercises for home-based training.
Multicomponent group-based and supervised exercise programOther
The intervention consists in a progressive multicomponent exercise training protocol. There are 2 sessions per week of 1 hour each for a total of 12 weeks. Sessions involve functional, resistance and balance exercises. Intensity is based on rating perceived effort (Borg's scale CR1-10) and volume towards 1 to 3 sets of 6 to 15 repetitions. Progressiveness in intensity and volume was based on effort tolerance, contraction regimen, velocity and load. Training schedule is described elsewhere (Delaire et al, 2023 ; doi.org/10.3390/nu15194100). Participants are allocated to an homogenous group based on functional status and cardiorespiratory comorbidities. Trained kinesiologists supervised the exercise program. Participants used free weights and elastic bands.
Follow-up at T3 + 6 months and T3 + 12 monthsOther
Follow-up at T3+6 months:
Investigators interviewed participants for 30 minutes. During the interview, data collection include:record of undesirable events in the interval T3 / T3+6 (falls, unscheduled hospitalization, illness, institutionalization), medication changes, ADL, IADL, FES-I, and RAPA. Goal-settings at T3 are adjusted if not reach. Finally, investigators stimulate intrinsic motivation for PA.
Follow-up at T3 + 12 months:
Investigators re-assessed physical capacity, physical activity level, quality of life, fall risk and frailty for the last visit. Data collection include:
- SPPB
- Handgrip test and maximal isometric strength of the quadriceps
- Questionnaires : SarQoL©, FES-I, RAPA
- Gait quality analysis using inertial sensors
- Undesirable events in the interval T3+6 / T3+12 (falls, unscheduled hospitalization, illness, institutionalization)
- Medication changes
- Body mass index
- ADL and IADL At last, goals in physical activity are adjusted if they are still not reach
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent group-based supervised exercise program | Other | 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 (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program. Receives: Diagnostic Test: Multidimensional assessments; Other: Multicomponent group-based and supervised exercise program; Other: Follow-up at T3 + 6 months and T3 + 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status
Functional status is assessed using the overall SPPB (Short Physical Performance Battery) score based on three components: 6 meters usual walking speed, 5 repetitions chair stand test, and static balance tests. (composite score /12). The SPPB score is calculate from the results in 3 subtests. It ranges from 1 to 12 points. Clinically meaningful change is 1 point.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Secondary outcomes (27)
Evaluation of effectiveness on muscle strength : Handgrip test (kg)
The subject has to perform 3 maximum isometric contractions on a dynamometer which records the force developed. The average of these 3 values will be retained. A value lower than <16kg for women and <27kg for men are considered abnormal and indicate the presence of probable sarcopenia.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on muscle strength : Maximal isometric strength of the quadriceps (kg)
The subject has to perform 3 maximum isometric muscular contractions separately against a dynamometer. The best performance (i.e. greatest strength measure) is collected.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : 5 repetitions chair stand test (s)
The subject has to stand with knee extended and sit from a chair 5 times without stopping
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : Time in TUG (s)
The subject must get up from a chair, walk at usual speed 3 meters, turn around, and sit down again. A value greater than or equal to 20 seconds will be considered abnormal.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : Lower body muscle power measured by a one sit-to-stand test perform at maximum speed (Neurocom Balance Master, Medimex®, France)
Estimation of lower limb muscle power based on the mean of the 3 repetitions of a sit-to-stand test perform separately. For each transfer, the lifting index (as a % of body weight), reaction time (s), the oscillation limit of the center of gravity, and the symmetry of the supports are measured
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of effectiveness on functional status : Gait quality analysis using inertial sensors (GaitUp, MindMaze®, Switzerland)
A 50 meters walking test perform at usual speed is realized. Data collection include : gait speed, gait variability, gait asymmetry, % flight time, % support time, % double support time, angle of attack, push-off angle, step height, step length, number of cycles in the U-turn, angles in the U-turn
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of muscle mass : SMI measured by bio-impedance analysis (kg.m2)
SMI is a relative index which is computed from the Sergi equation. Cut-off points are <7,0 and <5,5 for men and women respectively and are considered abnormal. These are the reference values for sarcopenia diagnosis.
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Data collection of muscle density (cm)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Data collection include of pennation angle (degree)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Data collection include of fiber length (cm)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of dependencies : Katz scale (Activities of Daily Living - ADL)
Katz scale (ADL) consists of 6 questions. Score varies from 0 to 6. The lower the score, the more dependant is the patient
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of dependencies : Lawton scale (Instrumental Activities of Daily Living-IADL)
Lawton scale (IADL) consists of 8 questions. Score varies from 0 to 8. The lower the score, the more dependant is the patient.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Record of undesirable events : Falls, unscheduled hospitalization, illness, institutionalization
Data are collected between intervals :
T3/T3+6 and T3+6/T3+12
Measured: initial assessment (baseline), following the exercise program (month 3), 6 months following the exercise program (month 9), last visit (month 15)
Evaluation of fear of falling : FES-I questionnaire (/64)
The validated French translated form is used. Questionnaire is self-administrated.
FES-I questionnaire (Falls Efficacy Scale-International) consists of 16 questions. Score varies from 16 to 64.
A fear of falling is considered to be present with score >23.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evolution of the level of physical activity : RAPA questionnaire (/10)
The RAPA is validated physical activity questionnaire in older adults. The score is calculated from the reported information of each visit.
Score varies from 0 to 10. The higher the score, the more physically active is the patient.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evolution of quality of life : SarQoL© questionnaire
The SarQoL© is a validated questionnaire in sarcopenic older adults. French validated translated form were used. The questionnaire is self-administrated. An overall change of 7,35 points in the questionnaire is considered to be clinically meaningful.
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of biomarkers : risk of fractures - Calcemia (mmol/L)
initial assessment (baseline), following the exercise program (month 3)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : risk of fractures - Vitamin D (nmol/L).
initial assessment (baseline), following the exercise program (month 3)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : exploratory Fibroblast Growth Factor 19 (FGF-19) (pg/L)
FGF-19 is analysed in plasma samples by ELISA method. Blood sample is collected in routine care.
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : nutritional status - Albumin (g/L)
Albumin (g/L)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : nutritional status - Pre-albumin (g/L)
Pre-albumin (g/L)
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : inflammation C-reactive protein
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of physical frailty : Fried criteria
Fried criteria include : unvolontary weight loss >5% during the last 12 months, self-reported exhaustion, low gait speed, low grip strength and poor physical activity level. 0 criterion = non frail ; 1-2 criteria = pre-frail ; ≥3 criteria = frail
Measured: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of sarcopenia : EWGSOP2
No sarcopenia = muscle strength and mass normal Probable sarcopenia = low muscle strength, normal muscle mass Sarcopenia = low muscle strength and mass Severe sarcopenia = low muscle strength and mass + poor physical performances
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : Mini Nutritional Assessment
This self-administrated questionnaire consists of 18 questions. Score varies from 0 to 30. From 17 to 24 points : risk of malnutrition Less than 17 points : poor nutritional status
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : caloric (kcal) needs and intakes from the dietary survey
Survey is self-administrated. Needs/Intake are calculated based on the survey.
Measured: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : protein (g/J) needs and intakes from the dietary survey
Survey is self-administrated. Needs/Intake are calculated based on the survey.
Measured: initial assessment (baseline), following the exercise program (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start10 Jul 2018
- Primary completionOct 2025 (estimated)
- Study completionOct 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 Mobility LimitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667664
- Sponsor's protocol ID
- 69HCL16_0324
- Acronym
- PREPA
- Status last verified
- Jun 2025
- First submitted
- 29 Jan 2018
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Study on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to Old People.
- ClinicalTrials.gov ID
- NCT03667664
- Acronym / sponsor ID
- PREPA / 69HCL16_0324
- Conditions
- Mobility Limitation, Physical Activity
- Keywords
- Autonomy, Elderly, Physical exercise, Nutrition, Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Sep 2018 (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.
According to several reports, the proportion of people aged 80yrs or older will be doubled within the next 25y, reaching 10% of the global population. Furthermore, the health life expectancy at 65y is 10.4y which remains much lower than the general life expectancy. As a result, there is a constant need of developing preventive strategies through multimodal programs.
Among the predictive factors of mobility disability with age, muscular weakness and decreased physical function are major components. These two factors are known of being responsible for falls and fractures that lead to decrease the quality of life and an increase in mortality.
Exercise and nutrition are the only components that have proven their efficacy to struggle mobility disability risk. It is important to integrate these two components in a sustained intervention within a multidimensional prevention program. However, there is a lack of implementation of these programs in primary care.
Indeed, neither the screening of older adults at risk of mobility disability, nor the preventive actions are usually implemented for this population. The implementation of a prevention care pathway, with personalized intervention and a sustained follow-up, along with supervised exercise training combined with nutritional counselling, is the public health imperatives.
Based on prevention care pathway that designed for community-dwelling older adults screened at risk of mobility disability. The purpose of this open cohort study was to highlight the efficacy and the feasibility of a multimodal program implemented on real-life setting specifically on the physical function and risk of mobility loss, along with their maintenance at 6-months and 1-year follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicomponent group-based supervised exercise program | Other | Diagnostic Test: Multidimensional assessments, Other: Multicomponent group-based and supervised 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 with at least 1 mobility disability risk factor (see intervention 1). These subjects are included in the protocol and participate in a multicomponent exercise program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patient eligible for the "mobility loss prevention" program
- At least one of the following signs:
Key exclusion criteria (5 listed)
- Patient who has not given consent to participate
- Patient under guardianship in retrospective phase
- Locomotor disability
- expectancy of life being under 12 months
- BMI ≥ 35 Kg/m2
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 |
|---|---|---|
| Multidimensional assessmentsEvaluation carried out during a day hospital at T0 (initial assessment) and T3 following the exercise program including: 1. Clinical assessment by a geriatrician 2. Nutritional assessment 3. Physical capacity assessment Following initial assessment (T0), older adults are included in the multicomponent exercise program if they present mobility disability risk factors including : * At least pre-frailty regarding Fried frailty criteria AND/OR * At least probable sarcopenia regarding EWGSOP2 algorithm AND/OR * The presence of at least an intermediate fall risk AND/OR * The presence of a fear of falling Following the exercise program (T3), all participants are re-assessed in the same way as T0. Investigators then set goals in physical activity with participants to maintain benefits and foster self-engagement in an healthy lifestyle. Additionnally, participants are orientated to exercise facilities and received an individualized booklet of exercises for home-based training. | Diagnostic test | Multicomponent group-based supervised exercise program |
| Multicomponent group-based and supervised exercise programThe intervention consists in a progressive multicomponent exercise training protocol. There are 2 sessions per week of 1 hour each for a total of 12 weeks. Sessions involve functional, resistance and balance exercises. Intensity is based on rating perceived effort (Borg's scale CR1-10) and volume towards 1 to 3 sets of 6 to 15 repetitions. Progressiveness in intensity and volume was based on effort tolerance, contraction regimen, velocity and load. Training schedule is described elsewhere (Delaire et al, 2023 ; doi.org/10.3390/nu15194100). Participants are allocated to an homogenous group based on functional status and cardiorespiratory comorbidities. Trained kinesiologists supervised the exercise program. Participants used free weights and elastic bands. | Other | Multicomponent group-based supervised exercise program |
| Follow-up at T3 + 6 months and T3 + 12 monthsFollow-up at T3+6 months: Investigators interviewed participants for 30 minutes. During the interview, data collection include:record of undesirable events in the interval T3 / T3+6 (falls, unscheduled hospitalization, illness, institutionalization), medication changes, ADL, IADL, FES-I, and RAPA. Goal-settings at T3 are adjusted if not reach. Finally, investigators stimulate intrinsic motivation for PA. Follow-up at T3 + 12 months: Investigators re-assessed physical capacity, physical activity level, quality of life, fall risk and frailty for the last visit. Data collection include: * SPPB * Handgrip test and maximal isometric strength of the quadriceps * Questionnaires : SarQoL©, FES-I, RAPA * Gait quality analysis using inertial sensors * Undesirable events in the interval T3+6 / T3+12 (falls, unscheduled hospitalization, illness, institutionalization) * Medication changes * Body mass index * ADL and IADL At last, goals in physical activity are adjusted if they are still not reach | Other | Multicomponent group-based supervised exercise program |
Primary outcome
Functional status
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Functional status is assessed using the overall SPPB (Short Physical Performance Battery) score based on three components: 6 meters usual walking speed, 5 repetitions chair stand test, and static balance tests. (composite score /12). The SPPB score is calculate from the results in 3 subtests. It ranges from 1 to 12 points. Clinically meaningful change is 1 point.
27 secondary outcomes
Evaluation of effectiveness on muscle strength : Handgrip test (kg)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on muscle strength : Maximal isometric strength of the quadriceps (kg)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : 5 repetitions chair stand test (s)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : Time in TUG (s)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of effectiveness on functional status : Lower body muscle power measured by a one sit-to-stand test perform at maximum speed (Neurocom Balance Master, Medimex®, France)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of effectiveness on functional status : Gait quality analysis using inertial sensors (GaitUp, MindMaze®, Switzerland)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of muscle mass : SMI measured by bio-impedance analysis (kg.m2)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of muscle mass : Ultrasonography of the vastus lateralis
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of dependencies : Katz scale (Activities of Daily Living - ADL)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of dependencies : Lawton scale (Instrumental Activities of Daily Living-IADL)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Record of undesirable events : Falls, unscheduled hospitalization, illness, institutionalization
Time frame: initial assessment (baseline), following the exercise program (month 3), 6 months following the exercise program (month 9), last visit (month 15)
Evaluation of fear of falling : FES-I questionnaire (/64)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evolution of the level of physical activity : RAPA questionnaire (/10)
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evolution of quality of life : SarQoL© questionnaire
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of biomarkers : risk of fractures - Calcemia (mmol/L)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : risk of fractures - Vitamin D (nmol/L).
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : exploratory Fibroblast Growth Factor 19 (FGF-19) (pg/L)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : nutritional status - Albumin (g/L)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : nutritional status - Pre-albumin (g/L)
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of biomarkers : inflammation C-reactive protein
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of physical frailty : Fried criteria
Time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)
Evaluation of sarcopenia : EWGSOP2
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : Mini Nutritional Assessment
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : caloric (kcal) needs and intakes from the dietary survey
Time frame: initial assessment (baseline), following the exercise program (month 3)
Evaluation of nutritional status : protein (g/J) needs and intakes from the dietary survey
Time frame: initial assessment (baseline), following the exercise program (month 3)
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 9 Sep 2025.
- 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional assessments, Multicomponent group-based and supervised exercise program and Follow-up at T3 + 6 months and T3 + 12 months in people with Mobility Limitation and Physical Activity, 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 11 inclusion and 5 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 9 Sep 2025. 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?
Functional status (time frame: initial assessment (baseline), following the exercise program (month 3), last visit (month 15)). 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 NCT03667664, 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 9 Sep 2025.