- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732923
Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program (APA&Co)
Maintaining physical activity post-cardiac rehabilitation (CR) has a major role in disease progression and patient prognosis, especially given its potential impact on physical condition. Unfortunately, during a nursing interview carried out 6 months after the CR at the Center Hospitalier de Cholet, we find that 40% do not maintain regular physical activity. This observation is in line with the literature since it emerges respectively at 2 months and 1 year post-CR that between 47% and 59% of patients do not comply with the recommendations in terms of physical activity (Guiraud et al, 2012).
However, data suggest that during the post-CR follow-up phase at 6 months, there could be a maintenance of the physical condition assessed via the distance at the 6-minutes walk test (Pavy et al, 2012; Racodon et al, 2019). There is a lack of data on the maintenance of physical condition beyond 6 months since no study has evaluated the maintenance of physical condition at 1 year post-CR by 6-minutes walk test.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cholet, France, 49300
- Centre Hospitalier de CHOLET
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- Patient participating in cardiac rehabilitation
- Patient who presented an acute coronary syndrome
- Patient having signed the written consent to participate
- Patient able to comply with the constraints of the protocol
Exclusion Criteria :
- Patient with heart failure
- Patient reluctant or unable to comply with the protocol
- Pregnant, parturient and nursing mothers
- Persons deprived of their liberty or under guardianship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental arm
This study is defined in 3 stages : STEP 1 : during the cardiac rehabilitation program over 4 weeks STEP 2 : monitoring at 6 months after cardiac rehabilitation program STEP 3 : monitoring at one year after cardiac rehabilitation program |
This study is defined in 3 stages : STEP 1 : during the cardiac rehabilitation program over 4 weeks 6 minute walk test, questionnaires STEP 2 : monitoring at 6 months after cardiac rehabilitation program Nurse interview, 6 minute walk test, questionnaires STEP 3 : monitoring at one year after cardiac rehabilitation program Nurse interview, 6 minute walk test, questionnaires |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
to study the maintenance of physical condition after cardiac rehabilitation program
Time Frame: at one year
|
6-minutes walk test
|
at one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
to study physical activity during the monitoring
Time Frame: at 6 months and one year
|
questionnaire IPAQ
|
at 6 months and one year
|
|
to study the motivation for physical activity during the monitoring
Time Frame: at 6 months and one year
|
questionnaire EMAPS
|
at 6 months and one year
|
|
to study obstacles to maintaining physical activity
Time Frame: at one year
|
nurse interview
|
at one year
|
|
to study the maintenance of physical condition after cardiac rehabilitation program
Time Frame: at 6 months
|
6-minutes walk test
|
at 6 months
|
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
- RC_2020_0001
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
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