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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04644861
Other study ID # RC31/19/0057
Secondary ID 2020-A01164-35
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2020
Est. completion date December 1, 2022

Study information

Verified date June 2022
Source University Hospital, Toulouse
Contact Emile ESCOURROU
Phone 5 61 80 01 23
Email emile.escourrou@dumg-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
France CHU de TOULOUSE Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility of the adapted physical activity program (ratio 1) total number of patients included in the study Month 0
Primary feasibility of the adapted physical activity program (ratio 2) number of patients who complete the program of adapted physical activity in totality Month 4
Secondary feasibility complementary criteria Month 0 number of patients who start the program of adapted physical activity Month 0
Secondary feasibility complementary criteria Month 4 reasons to not complete the program of adapted physical activity Month 4
Secondary organization feasibility number of canceled sessions Month 4
Secondary program adhesion (sessions realised) numbers of realised session Month 4
Secondary 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 Month 0
Secondary 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 Month 4
Secondary 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 Month 12
Secondary 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 Month 0
Secondary 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 Month 6
Secondary 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 Month 12
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