- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271112
Frailty Prevention in Elders From Reunion Island (5P-PILOTE)
Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance
In Reunion Island, people encounter environmental and social conditions leading to premature ageing and subsequent frailty. Social welfare has developped exercise programs to promote physical activity especially for elderly with higher risk factors of frailty, including low incomes.
The study evaluates the potent benefit effect of such exercise program on physical performance and frailty improvement in seniors from Reunion Island. All seniors participate to a 12-weeks exercise program especially dedicated to this targeted population needs and ability.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Regular physical activity has been shown to slow down sarcopenia, and increase strengh in elders. Nevertheless, senior with low incomes do not usually have access to physical activity areas.
Social partners are in close relationship with these elders and could promote free exercise programs dedicated to elders classified as "GIR5-6" according to the French scale "AGIRR". The AGIRR scale takes into account several criteria allowing the evaluation of the level of autonomy. The level of autonomy is closely related to frailty and could be reversed since elders have not reach a dependant-state. The "GIR5-6" level means that elderly people are still not dependant but exhibit several frailty risk factors.
The level of frailty and the physical performance of the participants is assessed by standard geriatric evaluation before the 12-wks exercice program. The improvement of the physical performance is assessed after he 12-wks exercice program.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-joseph, Réunion
- CHU Reunion Island
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Retired
- with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
- informed consent
Exclusion Criteria:
- physical activity prohibited
- under guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Exercise program
Participation to the 12-wks exercise program
|
Measurement of physical performance before and after the 12 wks-exercice program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical performance improvement
Time Frame: Physical performance improvement from baseline to 12 wks
|
Physical performance is assessed as as balance, walk and strength improvement
|
Physical performance improvement from baseline to 12 wks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life score
Time Frame: SF36 improvement from baseline to 12 wks
|
Improvement of quality of life assessed by SF36 v1 questionnaire
|
SF36 improvement from baseline to 12 wks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean-Marc EYCHENE, MD, Centre Hpospitalier Universitaire de La REUNION
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/CHU/00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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