PrescriptionSSOCaenNCT04919889
Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases
An observational study of Prescription and Physical Activity, run by University Hospital, Caen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prescription, Physical Activity, Chronic Disease
- What is being tested?
- Exercise prescription
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 10 Sep 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the individuals who were addressed to the municipally-based exercise on prescription program "Sport sur Ordonnance"
Who may be able to join
- All participant referred to the Exercise on Prescription Program (Caen)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Prescription, Physical Activity, Chronic Disease
- Being tested
- Exercise prescription
- Medical subject headings
- Motor Activity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise prescriptionOther
All individuals referred to the community-based Exercise on Prescription program
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT
The six minute walking test (distance in meters)
Measured: Change from Baseline 6MWT at the end of the program (4 months)
TUG
The Timed up and Go (time in seconds)
Measured: Change from Baseline TUG at the end of the program (4 months)
30s Stand Up Chair
number of times the patient comes to a full standing position in 30 seconds (n)
Measured: Change from Baseline 30s Stand Up Chair at the end of the program (4 months)
single leg stance test
length of time standing on one foot, right and left
Measured: Change from Baseline single leg stance test at the end of the program (4 months)
left back scratch
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)
Measured: Change from Baseline left back scratch at the end of the program (4 months)
toe-touch test
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
Measured: Change from Baseline toe-touch test at the end of the program (4 months)
Ricci & Gagnon
self-administered Ricci and Gagnon questionnaire about physical activity profile (score over 45, greater for higher levels of physical activity)
Measured: Change from Baseline Ricci & Gagnon at the end of the program (4 months)
SF12
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
Measured: Change from Baseline SF12 at the end of the program (4 months)
Personal Goal
Personal goal from the participants were collected
Measured: Achievement of personal goal at the end of the program (4 months)
Medical objective
Medical objective from the participants' doctors were collected
Measured: Achievement of medical goal at the end of the program (4 months)
Secondary outcomes (5)
Address
Individuals were asked whether or not they lived in priority areas
Measured: One assessment at the beginning, At enrollment
Age
Individuals were asked about their age
Measured: One assessment at the beginning, At enrollment
Body mass
Body mass (kg) was measured
Measured: One assessment at the beginning, At enrollment
Height
Height (cm) was measured
Measured: One assessment at the beginning, At enrollment
Chronic condition
The chronic condition for which individuals had been referred to the exercise program was collected.
Measured: One assessment at the beginning, At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Sep 2017
- Primary completion20 Jan 2018
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrescriptionStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919889
- Sponsor's protocol ID
- SSOCaen
- Acronym
- SSOCaen
- Status last verified
- Jun 2021
- First submitted
- 8 May 2021
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases
- ClinicalTrials.gov ID
- NCT04919889
- Acronym / sponsor ID
- SSOCaen / SSOCaen
- Conditions
- Prescription, Physical Activity, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 9 Jun 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the individuals who were addressed to the municipally-based exercise on prescription program "Sport sur Ordonnance"
Key inclusion criteria (1 listed)
- All participant referred to the Exercise on Prescription Program (Caen)
Key exclusion criteria (3 listed)
- 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.
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 prescriptionAll individuals referred to the community-based Exercise on Prescription program | Other | – |
Primary outcome
6MWT
Time frame: Change from Baseline 6MWT at the end of the program (4 months)
The six minute walking test (distance in meters)
TUG
Time frame: Change from Baseline TUG at the end of the program (4 months)
The Timed up and Go (time in seconds)
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)
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
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)
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
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)
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
Personal Goal
Time frame: Achievement of personal goal at the end of the program (4 months)
Personal goal from the participants were collected
Medical objective
Time frame: Achievement of medical goal at the end of the program (4 months)
Medical objective from the participants' doctors were collected
5 secondary outcomes
Address
Time frame: One assessment at the beginning, At enrollment
Age
Time frame: One assessment at the beginning, At enrollment
Body mass
Time frame: One assessment at the beginning, At enrollment
Height
Time frame: One assessment at the beginning, At enrollment
Chronic condition
Time frame: One assessment at the beginning, At enrollment
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 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Threshold-Based Versus Range-Based Exercise Intensity Prescription in Cardiac Rehabilitation
Cardiovascular Diseases, Cardiac Rehabilitation
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruitingObservational study
High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department
Acute Disease
Not yet recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prescription and Physical Activity, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 3 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 26 Mar 2025. 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 France. 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?
6MWT (time frame: Change from Baseline 6MWT at the end of the program (4 months)). The study lists 10 primary outcomes in all. 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 26 Mar 2025.