ClinicalTrials.gg
CompletedNCT032711125P-PILOTEUpdated Mar 4, 2020

Frailty Prevention in Elders From Reunion Island

An interventional study of Exercise program in Frail Elderly Syndrome and Physical Activity, sponsored by Centre Hospitalier Universitaire de la Réunion. Completed at 1 site in Réunion. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2020-03-04.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
97
Allocation
Not applicable
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Frail Elderly Syndrome
  • Physical Activity

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03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 97 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • physical activity prohibited
  • under guardianship
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
97 participants (actual)

Study arms

  • Other
    Exercise program

    Participation to the 12-wks exercise program

    Other: Exercise program

Interventions

  • OtherExercise program

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

06

What researchers measure

Primary outcomes

  1. Physical performance improvement

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

    Time frame: Physical performance improvement from baseline to 12 wks

Secondary outcomes

  1. Quality of life score

    Improvement of quality of life assessed by SF36 v1 questionnaire

    Time frame: SF36 improvement from baseline to 12 wks

07

Study locations

1 site
  • Chu Reunion Island
    Saint-joseph, Réunion
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in May 2019, 20 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 20 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2017
First posted
Sep 1, 2017
StartActual
Sep 4, 2017
Primary completionActual
May 7, 2019
CompletionActual
Jul 4, 2019
Last update
Mar 4, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03271112
Collaborators
Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, General Social Security Fund
Responsible party
Sponsor
First posted
Sep 1, 2017
Start date
Sep 4, 2017
Primary completion
May 7, 2019
Completion
Jul 4, 2019
Last update
Mar 4, 2020

Study contacts

Jean-Marc EYCHENE, MD
principal investigator · Centre Hpospitalier Universitaire de La REUNION

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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