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

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ClinicalTrials.gov Identifier: NCT03271112
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : September 7, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Frail Elderly Syndrome Physical Activity Other: Exercise program

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 115 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilote study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Exercise program
Participation to the 12-wks exercise program
Other: Exercise program
Measurement of physical performance before and after the 12 wks-exercice program

Outcome Measures

Primary Outcome Measures :
  1. Physical performance improvement [ Time Frame: Physical performance improvement from baseline to 12 wks ]
    Physical performance is assessed as as balance, walk and strength improvement

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: SF36 improvement from baseline to 12 wks ]
    Improvement of quality of life assessed by SF36 v1 questionnaire

Eligibility Criteria

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271112

Contact: Christine JUHEL, PHD +262262359949 christine.juhel@chu-reunion.fr

Chu Reunion Island Recruiting
Saint-joseph, Réunion
Contact: JUHEL CHRISTINE, PHD    +262262359949    christine.juhel@chu-reunion.fr   
Contact: EYCHENE JEAN-MARC, MD    +262262359949    jean-marc.eychene@chu-reunion.fr   
Principal Investigator: EYCHENE JEAN-MARC, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Centre National de la Recherche Scientifique, France
Institut de Recherche pour le Developpement
Caisse générale de sécurité sociale
Principal Investigator: Jean-Marc EYCHENE, MD Centre Hpospitalier Universitaire de La REUNION
More Information

Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT03271112     History of Changes
Other Study ID Numbers: 2017/CHU/00
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No