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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03271112
Other study ID # 2017/CHU/00
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2017
Est. completion date July 4, 2019

Study information

Verified date March 2020
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date July 4, 2019
Est. primary completion date May 7, 2019
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
Measurement of physical performance before and after the 12 wks-exercice program

Locations

Country Name City State
Réunion Chu Reunion Island Saint-joseph

Sponsors (4)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion Centre National de la Recherche Scientifique, France, General Social Security Fund, Institut de Recherche pour le Developpement

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical performance improvement Physical performance is assessed as as balance, walk and strength improvement Physical performance improvement from baseline to 12 wks
Secondary Quality of life score Improvement of quality of life assessed by SF36 v1 questionnaire SF36 improvement from baseline to 12 wks
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