NCT03271112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

August 31, 2017

Last Update Submit

March 3, 2020

Conditions

Frail Elderly SyndromePhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical performance improvement

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

    Physical performance improvement from baseline to 12 wks

Secondary Outcomes (1)

  • Quality of life score

    SF36 improvement from baseline to 12 wks

Study Arms (1)

Exercise program

OTHER

Participation to the 12-wks exercise program

Other: Exercise program

Interventions

Exercise programOTHER

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

Exercise program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Retired
  • with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
  • informed consent

You may not qualify if:

  • physical activity prohibited
  • under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reunion Island

Saint-Joseph, Reunion

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jean-Marc EYCHENE, MD

    Centre Hpospitalier Universitaire de La REUNION

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilote study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 1, 2017

Study Start

September 4, 2017

Primary Completion

May 7, 2019

Study Completion

July 4, 2019

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

RE(1)