Adapted Physical Activity Centre (in the) CITY for Elders Aged 70 and Over With at Least One Long Term Illness (CAPACITY70)
Primary Purpose
Chronic Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Program of adapted physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Disease focused on measuring Chronic Disease, adapted physical activity, primary care, Motor Activity, Elders
Eligibility Criteria
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
Sites / Locations
- CHU de TOULOUSERecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Elders aged 70
Arm Description
Program of adapted physical activity
Outcomes
Primary Outcome Measures
feasibility of the adapted physical activity program (ratio 1)
total number of patients included in the study
feasibility of the adapted physical activity program (ratio 2)
number of patients who complete the program of adapted physical activity in totality
Secondary Outcome Measures
feasibility complementary criteria Month 0
number of patients who start the program of adapted physical activity
feasibility complementary criteria Month 4
reasons to not complete the program of adapted physical activity
organization feasibility
number of canceled sessions
program adhesion (sessions realised)
numbers of realised session
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ). Score from 0 to 3000. higher score mean better outcome
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
Full Information
NCT ID
NCT04644861
First Posted
November 3, 2020
Last Updated
June 8, 2022
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT04644861
Brief Title
Adapted Physical Activity Centre (in the) CITY for Elders Aged 70 and Over With at Least One Long Term Illness
Acronym
CAPACITY70
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Elders aged 70 and over, living in Toulouse, with a chronic disease identified by the French social insurance as an Affection Longue Durée will be eligible to a 4 months physical activity program in a primary health center. This program will be proposed by their general practitioner. The aim of the study is to establish the feasibility of such program conduced exclusively in primary care.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Chronic Disease, adapted physical activity, primary care, Motor Activity, Elders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Elders aged 70
Arm Type
Other
Arm Description
Program of adapted physical activity
Intervention Type
Other
Intervention Name(s)
Program of adapted physical activity
Intervention Description
3 workouts of one hour every week during 4 months. Program will be conducted by adapted physical activity teachers and sports doctor.
Primary Outcome Measure Information:
Title
feasibility of the adapted physical activity program (ratio 1)
Description
total number of patients included in the study
Time Frame
Month 0
Title
feasibility of the adapted physical activity program (ratio 2)
Description
number of patients who complete the program of adapted physical activity in totality
Time Frame
Month 4
Secondary Outcome Measure Information:
Title
feasibility complementary criteria Month 0
Description
number of patients who start the program of adapted physical activity
Time Frame
Month 0
Title
feasibility complementary criteria Month 4
Description
reasons to not complete the program of adapted physical activity
Time Frame
Month 4
Title
organization feasibility
Description
number of canceled sessions
Time Frame
Month 4
Title
program adhesion (sessions realised)
Description
numbers of realised session
Time Frame
Month 4
Title
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Description
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Time Frame
Month 0
Title
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Description
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Time Frame
Month 4
Title
patient's quality of life measured by Whoqol-bref (World Health Organization Quality Of Life - Bref)
Description
patient's quality of life measured by Whoqol-bref. Score from 0 to 100, higher score mean better outcome
Time Frame
Month 12
Title
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Description
Global Physical Activity Questionnaire (GPAQ). Score from 0 to 3000. higher score mean better outcome
Time Frame
Month 0
Title
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Description
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
Time Frame
Month 6
Title
patient's physical activity measured by GPAQ Global Physical Activity Questionnaire
Description
Global Physical Activity Questionnaire (GPAQ), Score from 0 to 3000, higher score mean better outcome
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emile ESCOURROU
Phone
5 61 80 01 23
Ext
33
Email
emile.escourrou@dumg-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emile ESCOURROU
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de TOULOUSE
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey BELLOC
Email
belloc.a@chu-toulouse.fr
12. IPD Sharing Statement
Learn more about this trial
Adapted Physical Activity Centre (in the) CITY for Elders Aged 70 and Over With at Least One Long Term Illness
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