- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919889
Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases (SSOCaen)
The objectives were (1) to evaluate the characteristics of the patients referred, and (2) the effect of a community-based Exercise on Prescription program on their physical capacities and their quality of life.
The program consisted in 30 supervised physical activity (PA) group sessions (75 min) over a 4-month period and participant were prescribed the program by their doctors.
The participants had chronic diseases among type 2 diabetes, mental disorders, musculoskeletal disorders, childhood and adult obesity and stabilized cardiovascular diseases.
Tests and questionnaires were completed before and after the program. Physical tests were the 6-minute walk test, the timed up & go, the 30-s stand up chair, the single leg support test and the back scratch and toe-touch tests. Questionnaires were the self-administered Ricci and Gagnon questionnaire about PA level and the 12-Item Short Form Survey for measuring quality of life.
Personal goal from the participants and medical objective from their doctors were collected before the program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Caen, France, 14000
- CHU Caen Normandie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All participant referred to the Exercise on Prescription Program (Caen)
Exclusion Criteria:
- French language not sufficiently read and/or spoken
- Lack of clear information on the study
- Alteration of higher functions or sensory disturbance making understanding and adherence to the research protocol impossible.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6MWT
Time Frame: Change from Baseline 6MWT at the end of the program (4 months)
|
The six minute walking test (distance in meters)
|
Change from Baseline 6MWT at the end of the program (4 months)
|
TUG
Time Frame: Change from Baseline TUG at the end of the program (4 months)
|
The Timed up and Go (time in seconds)
|
Change from Baseline TUG at the end of the program (4 months)
|
30s Stand Up Chair
Time Frame: Change from Baseline 30s Stand Up Chair at the end of the program (4 months)
|
number of times the patient comes to a full standing position in 30 seconds (n)
|
Change from Baseline 30s Stand Up Chair at the end of the program (4 months)
|
single leg stance test
Time Frame: Change from Baseline single leg stance test at the end of the program (4 months)
|
length of time standing on one foot, right and left
|
Change from Baseline single leg stance test at the end of the program (4 months)
|
left back scratch
Time Frame: Change from Baseline left back scratch at the end of the program (4 months)
|
Distance between one hand over the shoulder with the palm touching the back down and the other hand up the back from the waist with the palm facing outwards (in centimeters)
|
Change from Baseline left back scratch at the end of the program (4 months)
|
toe-touch test
Time Frame: Change from Baseline toe-touch test at the end of the program (4 months)
|
Distance from the fingers to the floor whil the participant is bending from the hips forward and try to touch the ends of the fingers to the tips of the toes
|
Change from Baseline toe-touch test at the end of the program (4 months)
|
Ricci & Gagnon
Time Frame: Change from Baseline Ricci & Gagnon at the end of the program (4 months)
|
self-administered Ricci and Gagnon questionnaire about physical activity profile (score over 45, greater for higher levels of physical activity)
|
Change from Baseline Ricci & Gagnon at the end of the program (4 months)
|
SF12
Time Frame: Change from Baseline SF12 at the end of the program (4 months)
|
the 12-Item Short Form Survey (SF-12) for measuring quality of life, population mean 50; range 0-100, greater scores for better quality of life
|
Change from Baseline SF12 at the end of the program (4 months)
|
Personal Goal
Time Frame: Achievement of personal goal at the end of the program (4 months)
|
Personal goal from the participants were collected
|
Achievement of personal goal at the end of the program (4 months)
|
Medical objective
Time Frame: Achievement of medical goal at the end of the program (4 months)
|
Medical objective from the participants' doctors were collected
|
Achievement of medical goal at the end of the program (4 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Address
Time Frame: One assessment at the beginning, At enrollment
|
Individuals were asked whether or not they lived in priority areas
|
One assessment at the beginning, At enrollment
|
Age
Time Frame: One assessment at the beginning, At enrollment
|
Individuals were asked about their age
|
One assessment at the beginning, At enrollment
|
Body mass
Time Frame: One assessment at the beginning, At enrollment
|
Body mass (kg) was measured
|
One assessment at the beginning, At enrollment
|
Height
Time Frame: One assessment at the beginning, At enrollment
|
Height (cm) was measured
|
One assessment at the beginning, At enrollment
|
Chronic condition
Time Frame: One assessment at the beginning, At enrollment
|
The chronic condition for which individuals had been referred to the exercise program was collected.
|
One assessment at the beginning, At enrollment
|
Collaborators and Investigators
Sponsor
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
- SSOCaen
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
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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