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

March 3, 2020 updated by: Centre Hospitalier Universitaire de la Réunion

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

Completed

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

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Réunion
      • Saint-joseph, Réunion
        • CHU Reunion Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Collaborators

Institut de Recherche pour le Developpement
Centre National de la Recherche Scientifique, France
General Social Security Fund

Investigators

  • Principal Investigator: Jean-Marc EYCHENE, MD, Centre Hpospitalier Universitaire de La REUNION

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

May 7, 2019

Study Completion (Actual)

July 4, 2019

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

August 31, 2017

First Posted (Actual)

September 1, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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