Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program (APA&Co)
Primary Purpose
Coronary Disease, Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assigned intervention - procedure
Sponsored by
About this trial
This is an interventional other trial for Coronary Disease focused on measuring physical condition, physical activity, cardiac rehabilitation
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier de CHOLET
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
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
Outcomes
Primary Outcome Measures
to study the maintenance of physical condition after cardiac rehabilitation program
6-minutes walk test
Secondary Outcome Measures
to study the maintenance of physical condition after cardiac rehabilitation program
6-minutes walk test
to study physical activity during the monitoring
questionnaire IPAQ
to study the motivation for physical activity during the monitoring
questionnaire EMAPS
to study obstacles to maintaining physical activity
nurse interview
Full Information
NCT ID
NCT04732923
First Posted
January 15, 2021
Last Updated
March 27, 2023
Sponsor
Centre Hospitalier de Cholet
1. Study Identification
Unique Protocol Identification Number
NCT04732923
Brief Title
Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program
Acronym
APA&Co
Official Title
Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Cholet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The objective of this study is to examine the maintenance of physical condition at one year after cardiac rehabilitation program by the 6-minutes walk test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Acute Coronary Syndrome
Keywords
physical condition, physical activity, cardiac rehabilitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Assigned intervention - procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
to study the maintenance of physical condition after cardiac rehabilitation program
Description
6-minutes walk test
Time Frame
at one year
Secondary Outcome Measure Information:
Title
to study the maintenance of physical condition after cardiac rehabilitation program
Description
6-minutes walk test
Time Frame
at 6 months
Title
to study physical activity during the monitoring
Description
questionnaire IPAQ
Time Frame
at 6 months and one year
Title
to study the motivation for physical activity during the monitoring
Description
questionnaire EMAPS
Time Frame
at 6 months and one year
Title
to study obstacles to maintaining physical activity
Description
nurse interview
Time Frame
at one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Vollot
Organizational Affiliation
Centre Hospitalier de Cholet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Da Ros Vettoretto
Organizational Affiliation
Centre Hospitalier de Cholet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de CHOLET
City
Cholet
ZIP/Postal Code
49300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Maintenance of Physical Condition and Physical Activity at One Year After Cardiac Rehabilitation Program
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