- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04774276
Protocol in Reeducation Occupational Therapist in Coronary Patients
Study Overview
Status
Conditions
Detailed Description
The occupational therapy goals are in line with the theoretical objectives of coronary rehabilitation. At present, there is a lack of data on the benefits of coronary occupational therapy rehabilitation.
Goals : Evaluation of the quality of life of coronary heart patients who have benefited from cardiac rehabilitation optimized by secondary occupational therapy sessions:
Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.
Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Saint-Étienne, France, 42055
- CHU de Saint-Etienne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Coronary artery disease
- Included in the cardiac rehabilitation protocol in Saint Etienne university hospital
Exclusion Criteria:
- Patients who not perform all sessions of the cardiac rehabilitation protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group with occupational therapist
Patient with Coronary Artery Disease (CAD) will be included.
They will have the cardiac rehabilitation protocol (4 weeks) with occupational therapist as usual practice.
The inclusion in this group will be prospective, from January 2021.
|
This intervention (occupational therapist) have been added since 2021 for all patients who need a cardiac rehabilitation protocol. Occupational therapy is scheduled with sessions 3 times a week for 1 month. |
|
Group without occupational therapist
Patient with Coronary Artery Disease (CAD) will be included.
They have done the cardiac rehabilitation protocol (4 weeks) without occupational therapist until december 2020.
The inclusion in this group will be retrospective,
|
cardiac rehabilitation protocol without occupational therapist will be performed (usual practice before January 2021).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form (SF-36) questionnaire score
Time Frame: week 5
|
The SF-36 is a self-questionnaire to assess the quality of life and contains 36 items with minimum score 0 (bad quality life) and maximum score at 100 (good quality life). Done one week after the end of cardiac rehabilitation protocol |
week 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strength of biceps muscle (Kg)
Time Frame: week 5
|
Measured by handgrip Done one week after the end of cardiac rehabilitation protocol |
week 5
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 minutes walk test (TM6)
Time Frame: week 5
|
Measured by the distance in metres at the walking time of 6 minutes. Done one week after the end of cardiac rehabilitation protocol |
week 5
|
Collaborators and Investigators
Investigators
- Principal Investigator: DAVID HUPIN, MD, CHU St Etienne
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN022021/CHUSTE
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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