- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644861
Adapted Physical Activity Centre (in The) CITY for Elders Aged 70 and Over with At Least One Long Term Illness (CAPACITY70)
Evaluation of the Feasibility of a Physical Activity Program Adapted for Primary Care, for People Aged 70 and Over Who Have At Least One Long-term Illness
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The number of elders aged 70 and over and suffering of a chronic disease are increasing in our country. These patients are at risk of sarcopenia which can lead to an increasing risk of falls and hospitalization, loss of autonomy, and morbi-mortality. Twelve weeks adapted physical activity program can manage sarcopenia in elders. One of the difficulties to propose such a program to elders patients is the difficulty to reach the program center due to mobility deficiency. Our hypothesis is that proposing an adapted physical activity in a primary health care center, in the city of the patient, could help the participation.
Eligible patients addressed by their general practitioner will perform 4 months adapted physical activity program in the CAPA-CITY center (MSPU La Providence).
The inclusion will be realized by the sports doctor of CAPA-CITY. At M2, sport doctor and adapted physical activity teacher will meet the patient to readapt the program taking in count his particularity and wishes.
At M4 M6 and M12, an independent global evaluation will be realized by training nurse and clinical research associate.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31000
- CHU de Toulouse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Elders aged 70 and over, with a chronic disease recognize as an Long Term Affection by the French social insurance.
- Living at home in Toulouse
- With a general practitioner working in Toulouse and agreed to participate to the CAPA-CITY70 program research
Exclusion Criteria:
- Elders living in nursing home
- Elders dependent for daily activity (score < 5.5 Autonomy scale of Katz)
- Elders with dementia according to DSM V criteria
- Elders participating in another research project
- Contraindication for physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Elders aged 70
Program of adapted physical activity
|
3 workouts of one hour every week during 4 months.
Program will be conducted by adapted physical activity teachers and sports doctor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
feasibility of the adapted physical activity program (ratio 1)
Time Frame: Month 0
|
total number of patients included in the study
|
Month 0
|
|
feasibility of the adapted physical activity program (ratio 2)
Time Frame: Month 4
|
number of patients who complete the program of adapted physical activity in totality
|
Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
feasibility complementary criteria Month 0
Time Frame: Month 0
|
number of patients who start the program of adapted physical activity
|
Month 0
|
|
feasibility complementary criteria Month 4
Time Frame: Month 4
|
reasons to not complete the program of adapted physical activity
|
Month 4
|
|
organization feasibility
Time Frame: Month 4
|
number of canceled sessions
|
Month 4
|
|
program adhesion (sessions realised)
Time Frame: Month 4
|
numbers of realised session
|
Month 4
|
|
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time Frame: Month 0
|
patient's quality of life measured by Whoqol-bref.
Score from 0 to 100, higher score mean better outcome
|
Month 0
|
|
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time Frame: Month 4
|
patient's quality of life measured by Whoqol-bref.
Score from 0 to 100, higher score mean better outcome
|
Month 4
|
|
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Time Frame: Month 12
|
patient's quality of life measured by Whoqol-bref.
Score from 0 to 100, higher score mean better outcome
|
Month 12
|
|
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time Frame: Month 0
|
Global Physical Activity Questionnaire (GPAQ).
Score from 0 to 3000.
higher score mean better outcome
|
Month 0
|
|
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time Frame: Month 6
|
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
|
Month 6
|
|
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Time Frame: Month 12
|
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
|
Month 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emile ESCOURROU, CHU Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/19/0057
- 2020-A01164-35 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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