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Frailty Prevention in Elders From Reunion Island (5P-PILOTE)

Primary Purpose

Frail Elderly Syndrome, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Exercise program
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly Syndrome

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Reunion Island

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise program

Arm Description

Participation to the 12-wks exercise program

Outcomes

Primary Outcome Measures

Physical performance improvement
Physical performance is assessed as as balance, walk and strength improvement

Secondary Outcome Measures

Quality of life score
Improvement of quality of life assessed by SF36 v1 questionnaire

Full Information

First Posted
August 31, 2017
Last Updated
March 3, 2020
Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, General Social Security Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03271112
Brief Title
Frailty Prevention in Elders From Reunion Island
Acronym
5P-PILOTE
Official Title
Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
July 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
Collaborators
Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, General Social Security Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilote study
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise program
Arm Type
Other
Arm Description
Participation to the 12-wks exercise program
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Measurement of physical performance before and after the 12 wks-exercice program
Primary Outcome Measure Information:
Title
Physical performance improvement
Description
Physical performance is assessed as as balance, walk and strength improvement
Time Frame
Physical performance improvement from baseline to 12 wks
Secondary Outcome Measure Information:
Title
Quality of life score
Description
Improvement of quality of life assessed by SF36 v1 questionnaire
Time Frame
SF36 improvement from baseline to 12 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc EYCHENE, MD
Organizational Affiliation
Centre Hpospitalier Universitaire de La REUNION
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Reunion Island
City
Saint-joseph
Country
Réunion

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Frailty Prevention in Elders From Reunion Island

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