FragilityNCT02690402
Fragility and Adapted Physical Activity
A study testing adapted physical activity in people with Fragility, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fragility
- What is being tested?
- adapted physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 970 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2016to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patient who signed the informed consent
- Older men and women ≥ 65 years
- Can walk without technical help
Who cannot join
- Patient with protective measures (guardianship, curatorship, and deprivation of liberty).
- Patient with a neurological problem
- No affiliation to a social security scheme (beneficiary or assignee)
- Knee and / or hip prosthesis
- Orthopedic complications with repercussions on walking activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fragility Multidisciplinary Evaluation and Adapted Physical Activity
Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Frailty is generally considered as a state that precedes dependent status and, unlike the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and quantify the indicators above the dependence of the elderly from a multidisciplinary approach to frailty, is a critical public health issue for developing non-drug therapeutic interventions adapted to delay the institutionalization. Through this study, it is to identify risk and protective factors of frailty and their relationships with physical activity, evaluate them and propose an appropriate care to the patient. This study should enable the production of new scientific knowledge to improve the health and quality of life of older people.
Read the detailed description
Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Frailty is generally considered as a state that precedes dependent status and, unlike the latter, is still reversible (Fried et al., 2001). These authors proposed criteria: physical inactivity (low levels of physical activity), unintentional weight loss (more than 5% of body weight over 6 months), perceived general fatigue, weakness of grip strength (handgrip) and slow speed walk. Nevertheless, at present, other more objective evaluation methods that include mobility, balance, muscle strength, endurance and cognition are necessary. Furthermore, psychological characteristics have not been studied with frailty indicators, except to walk speed. Now, these last are important levers of people adherence to physical activity programs (Baert et al., 2011). In this sense, better understand and quantify the indicators above the dependence of the elderly from a multidisciplinary approach to frailty, is a critical public health issue for developing non-drug therapeutic interventions adapted to delay the institutionalization.
The proposed study is to items (a) to characterize the functional dimensions of frailty from objective indicators and (b) putting them in relation to the cognitive and psychosocial characteristics of the elderly in order to define individual devices of care through physical activity.
To meet these objectives, it is necessary to include a large number of people in a comprehensive evaluation protocol physical, and their psycho-social and cognitive characteristics.
The research will begin with an inclusive visit by a medical doctor. Evaluation begins with a impedancemetric measurement, followed by posturographic evaluation. Then, in a first phase, patients will perform walk tests (e.g., 6 minutes, 10 m) during which spatiotemporal parameters of gait cycle, and the electromyographic activity of the different muscles of the lower limbs will be quantified. After the walk test, each subject will receive an evaluation of the strength of the ankle and knee muscles by an isokinetic dynamometer. During these contractions, the surface electromyographic activity of patients will also be recorded. In a second phase, subjects will perform a series of repetitions at 50% of maximum voluntary contraction (MVC) on the isokinetic dynamometer, to measure strength endurance. Thirdly, participants will be asked to complete cognitive tests and psychometric questionnaires. Finally, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.
Through this assessment, it is to identify risk and protective factors of frailty and their relationships with physical activity, evaluate them and propose an appropriate care to the patient. This study should enable the production of new scientific knowledge to improve the health and quality of life of older people.
- Conditions
- Fragility
- Being tested
- adapted physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adapted physical activityBehavioural
The study begins with an evaluation of physical strenght and cognitive and psychometric assessment.Then, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.
| Study group | Role | What they receive |
|---|---|---|
| adapted physical activity | Experimental | a personalized care will be offered in terms of adapted physical activity Receives: Behavioral: adapted physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait analysis
Measured: change from baseline physical activity at 3 months
Isocinetic evaluation
Measured: change from baseline physical activity at 3 months
Questionnaire : Physical activity, psychometric
Measured: change from baseline physical activity at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start12 Sep 2016
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FragilityStudies of the same condition, open and under way.
- 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
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690402
- Sponsor's protocol ID
- 15-PP-12
- Status last verified
- Mar 2026
- First submitted
- 5 Oct 2015
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Piche E, Gerus P, Chorin F, Jaafar A, Guerin O, Zory R. The effect of different dual tasks conditions on gait kinematics and spatio-temporal walking parameters in older adults. Gait Posture. 2022 Jun;95:63-69. doi: 10.1016/j.gaitpost.2022.04.006. Epub 2022 Apr 12.
PubMed 35453085Deshayes M, Corrion K, Zory R, Guerin O, Chorin F, d'Arripe-Longueville F. Relationship between personality and physical capacities in older adults: The mediating role of subjective age, aging attitudes and physical self-perceptions. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104417. doi: 10.1016/j.archger.2021.104417. Epub 2021 Apr 8.
PubMed 33882421Piche E, Chorin F, Gerus P, Jaafar A, Reneaud N, Guerin O, Zory R. Validity of a simple sit-to-stand method for assessing force-velocity profile in older adults. Exp Gerontol. 2021 Dec;156:111595. doi: 10.1016/j.exger.2021.111595. Epub 2021 Oct 19.
PubMed 34673170Roche N, Chorin F, Gerus P, Deshayes M, Guerin O, Zory R. Effects of age, gender, frailty and falls on spatiotemporal gait parameters: a retrospective cohort study. Eur J Phys Rehabil Med. 2021 Dec;57(6):923-930. doi: 10.23736/S1973-9087.21.06831-3. Epub 2021 May 18.
PubMed 34002975
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fragility Multidisciplinary Evaluation and Adapted Physical Activity
- ClinicalTrials.gov ID
- NCT02690402
- Acronym / sponsor ID
- 15-PP-12
- Conditions
- Fragility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Frailty is generally considered as a state that precedes dependent status and, unlike the latter, is still reversible (Fried et al., 2001). Now, it's necessary to understand and quantify the indicators above the dependence of the elderly from a multidisciplinary approach to frailty, is a critical public health issue for developing non-drug therapeutic interventions adapted to delay the institutionalization. Through this study, it is to identify risk and protective factors of frailty and their relationships with physical activity, evaluate them and propose an appropriate care to the patient. This study should enable the production of new scientific knowledge to improve the health and quality of life of older people.
Detailed description
Older people are a very heterogeneous population characterized by a high interindividual variability. Functional abilities (walking, transfers ...) used to classify individuals aged (Lalive d'épinay et al., 1999) in three categories: independent, frail and dependent (HAS, 2005). Frailty is generally considered as a state that precedes dependent status and, unlike the latter, is still reversible (Fried et al., 2001). These authors proposed criteria: physical inactivity (low levels of physical activity), unintentional weight loss (more than 5% of body weight over 6 months), perceived general fatigue, weakness of grip strength (handgrip) and slow speed walk. Nevertheless, at present, other more objective evaluation methods that include mobility, balance, muscle strength, endurance and cognition are necessary. Furthermore, psychological characteristics have not been studied with frailty indicators, except to walk speed. Now, these last are important levers of people adherence to physical activity programs (Baert et al., 2011). In this sense, better understand and quantify the indicators above the dependence of the elderly from a multidisciplinary approach to frailty, is a critical public health issue for developing non-drug therapeutic interventions adapted to delay the institutionalization.
The proposed study is to items (a) to characterize the functional dimensions of frailty from objective indicators and (b) putting them in relation to the cognitive and psychosocial characteristics of the elderly in order to define individual devices of care through physical activity.
To meet these objectives, it is necessary to include a large number of people in a comprehensive evaluation protocol physical, and their psycho-social and cognitive characteristics.
The research will begin with an inclusive visit by a medical doctor. Evaluation begins with a impedancemetric measurement, followed by posturographic evaluation. Then, in a first phase, patients will perform walk tests (e.g., 6 minutes, 10 m) during which spatiotemporal parameters of gait cycle, and the electromyographic activity of the different muscles of the lower limbs will be quantified. After the walk test, each subject will receive an evaluation of the strength of the ankle and knee muscles by an isokinetic dynamometer. During these contractions, the surface electromyographic activity of patients will also be recorded. In a second phase, subjects will perform a series of repetitions at 50% of maximum voluntary contraction (MVC) on the isokinetic dynamometer, to measure strength endurance. Thirdly, participants will be asked to complete cognitive tests and psychometric questionnaires. Finally, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.
Through this assessment, it is to identify risk and protective factors of frailty and their relationships with physical activity, evaluate them and propose an appropriate care to the patient. This study should enable the production of new scientific knowledge to improve the health and quality of life of older people.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adapted physical activity | Experimental | Behavioral: adapted physical activitya personalized care will be offered in terms of adapted physical activity |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patient who signed the informed consent
- Older men and women ≥ 65 years
- Can walk without technical help
Key exclusion criteria (5 listed)
- Patient with protective measures (guardianship, curatorship, and deprivation of liberty).
- Patient with a neurological problem
- No affiliation to a social security scheme (beneficiary or assignee)
- Knee and / or hip prosthesis
- Orthopedic complications with repercussions on walking activities
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 |
|---|---|---|
| adapted physical activityThe study begins with an evaluation of physical strenght and cognitive and psychometric assessment.Then, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment. | Behavioural | adapted physical activity |
Primary outcome
Gait analysis
Time frame: change from baseline physical activity at 3 months
Isocinetic evaluation
Time frame: change from baseline physical activity at 3 months
Questionnaire : Physical activity, psychometric
Time frame: change from baseline physical activity at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Background: PubMed 35453085Piche E, Gerus P, Chorin F, Jaafar A, Guerin O, Zory R. The effect of different dual tasks conditions on gait kinematics and spatio-temporal walking parameters in older adults. Gait Posture. 2022 Jun;95:63-69. doi: 10.1016/j.gaitpost.2022.04.006. Epub 2022 Apr 12.
- Background: PubMed 33882421Deshayes M, Corrion K, Zory R, Guerin O, Chorin F, d'Arripe-Longueville F. Relationship between personality and physical capacities in older adults: The mediating role of subjective age, aging attitudes and physical self-perceptions. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104417. doi: 10.1016/j.archger.2021.104417. Epub 2021 Apr 8.
- Background: PubMed 34673170Piche E, Chorin F, Gerus P, Jaafar A, Reneaud N, Guerin O, Zory R. Validity of a simple sit-to-stand method for assessing force-velocity profile in older adults. Exp Gerontol. 2021 Dec;156:111595. doi: 10.1016/j.exger.2021.111595. Epub 2021 Oct 19.
- Results publication: PubMed 34002975Roche N, Chorin F, Gerus P, Deshayes M, Guerin O, Zory R. Effects of age, gender, frailty and falls on spatiotemporal gait parameters: a retrospective cohort study. Eur J Phys Rehabil Med. 2021 Dec;57(6):923-930. doi: 10.23736/S1973-9087.21.06831-3. Epub 2021 May 18.
- Individual participant dataSharing planned: Undecided
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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.
Olivier GUERIN, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Fragility, run by Centre Hospitalier Universitaire de Nice 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 3 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: finished, as of the sponsor's last update on 24 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gait analysis (time frame: change from baseline physical activity at 3 months). The study lists 3 primary outcomes in all. 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 NCT02690402, which also lists 4 linked publications.
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 24 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.