Frail Elderly Syndrome5P-PILOTENCT03271112
Frailty Prevention in Elders From Reunion Island
A study testing Exercise program in people with Frail Elderly Syndrome and Physical Activity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Physical Activity
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteReunion
- Study dates
- 4 Sep 2017to 4 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Retired
- with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
- informed consent
Who cannot join
- physical activity prohibited
- under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Frail Elderly Syndrome, Physical Activity
- Being tested
- Exercise program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Measurement of physical performance before and after the 12 wks-exercice program
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Other | Participation to the 12-wks exercise program Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance improvement
Physical performance is assessed as as balance, walk and strength improvement
Measured: 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
Measured: SF36 improvement from baseline to 12 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start4 Sep 2017
- Primary completion7 May 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilote study
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, General Social Security Fund
- Responsible party
- Sponsor
- Investigators
- Jean-Marc EYCHENE, MD, Principal investigator, Centre Hpospitalier Universitaire de La REUNION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271112
- Sponsor's protocol ID
- 2017/CHU/00
- Acronym
- 5P-PILOTE
- Status last verified
- Mar 2020
- First submitted
- 31 Aug 2017
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Prevention in Elderly People From Reunion Island: Effects of Adaptated Exercises on Physical Performance
- ClinicalTrials.gov ID
- NCT03271112
- Acronym / sponsor ID
- 5P-PILOTE / 2017/CHU/00
- Conditions
- Frail Elderly Syndrome, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut de Recherche pour le Developpement, General Social Security Fund
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilote study
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Other | Other: Exercise programParticipation to the 12-wks exercise program |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Retired
- with an autonomy level corresponding to the "GIR 5-6" level of the French "AGIRR scale"
- informed consent
Key exclusion criteria (2 listed)
- physical activity prohibited
- under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programMeasurement of physical performance before and after the 12 wks-exercice program | Other | Exercise program |
Primary outcome
Physical performance improvement
Time frame: Physical performance improvement from baseline to 12 wks
Physical performance is assessed as as balance, walk and strength improvement
1 secondary outcome
Quality of life score
Time frame: SF36 improvement from baseline to 12 wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Frail Elderly Syndrome
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Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
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Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
Diabetes Type 2, Frail Elderly Syndrome
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Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
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The Impact of Geriatric Assessment on the Treatment Plan of Elderly Patients With T2DM
Type2diabetes, Frail Elderly Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc EYCHENE, MD principal investigator
Centre Hpospitalier Universitaire de La REUNION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Frail Elderly Syndrome and Physical Activity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance improvement (time frame: Physical performance improvement from baseline to 12 wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.