Impact on Physical Activity of Coronary Patients in Phase 3 of a Therapeutic Consolidation Educational Program Involving a "Patient Partner" Associated With a Healthcare Professional.

Not Applicable

Recruiting

• Conditions: Myocardial Infarction
• Interventions: Other: Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership; Other: Teleconsultation at 2 months; Other: Teleconsultation at 4 months; Other: Remote group education workshop; Diagnostic Test: 6-minute walk test and administers the modified Borg scale at its conclusion.; Diagnostic Test: Biological check-up; Device: Accelerometer; Other: Administration of a logbook

• Registration Number: NCT05927363
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

Following myocardial infarction, cardiac rehabilitation has undeniable benefits on criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:

1. immediate post-acute, in a cardiology department,

2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,

3. Resumption of active life by the patient. Indeed, one of the major aims of secondary prevention is long-term adherence to physical activity.However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, and the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after Phase 2 of CR is a major objective.

Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. This study aims to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on moderate-to-sustained physical activity (\> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

Detailed Description

Following myocardial infarction, cardiac rehabilitation has shown undeniable benefits on strong criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:

1. immediate post-acute, in a cardiology department,

2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,

3. Resumption of active life by the patient: one of the major aims of secondary prevention is long-term adherence to physical activity.

The importance of phase 2 of cardiac rehabilitation is particularly emphasized and is the subject of recommendations by learned societies. The aim is to re-train the patient under paramedical and medical supervision, and to induce behavioral changes through specific therapeutic education. Exercise re-training aims to increase the patient's cardiorespiratory functional capacity and their ability to do physical activity of moderate-to-sustained intensity. One of the most commonly used units to calculate the intensity of physical activity is the Metabolic Equivalent of Task (MET). The higher the intensity of the activity, the higher the number of METs. Physical activity of at least moderate intensity, as recommended in the long-term care of coronary patients corresponds to 3 METs. The therapeutic objective by international recommendations, and explained to patients during phase 2 CR, is to achieve 150 minutes a week of moderate-to-sustained physical activity (3 METs or more). However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, which means that the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after phase 2 of CR, is a major objective.

Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. Objective, validated measures of physical activity such as accelerometry have not proved their long-term efficacy (6 months being the classically explored endpoint). An intervention establishing a patient-centered relationship and cognitive-behavioral elements would seem to be a perspective of choice to be explored, therapeutic education having been little explored in phase 3 of cardiac rehabilitation and in the long term. To address some of the barriers identified in qualitative studies, the joint participation of a "patient partner" would seem to of interest. The PP is a patient who has acquired knowledge of their disease over time, through experience and experience and therapeutic education. They encourage dialogue between care teams and patients, facilitating patients' self-expression, and contributes to a better understanding of the discourse.

The hypothesis is that a therapeutic educational consolidation program, involving a "patient partner" associated with a health professional, will increase the level of physical activity of coronary patients in Phase 3 of cardiac rehabilitation.

The main objective of this study is to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on the level of moderate to sustained physical activity (\> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-22
• Study First Posted: 2023-07-03
• Study Start: 2024-01-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-10-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Patient of legal age (≥ 18 years).
• Patient having undergone phase 2 treatment in the cardiovascular rehabilitation department of the CHU for myocardial infarction.
• Patient with a means of communication that allows easy internet connection (i.e. a smartphone).
• Patient fluent in French.
• Patient who has given free informed consent.
• Patient affiliated or beneficiary of a health insurance scheme.

Exclusion Criteria

• Patient with severe or unstable comorbidity (respiratory insufficiency renal failure, decompensated heart failure). heart failure).
• Patient with unstable angina.
• Patient with contraindications to physical activity following physical activity following cardiovascular rehabilitation (according to medical discussion, based on the recommendations of the French Society of Cardiology).
• Patient with no suitable means of communication.
• Patient under court protection, guardianship or curatorship.
• Pregnant, parturient or breast-feeding patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Administration of a logbook	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Teleconsultation at 2 months	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Remote group education workshop	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	6-minute walk test and administers the modified Borg scale at its conclusion.	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Biological check-up	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Teleconsultation at 4 months	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Experimental Group	Accelerometer	Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.

Primary Outcome Measures

Name	Time	Method
Moderate-to-sustained physical activity in the Experimental Group	Month 6	The accelerometer will be used to evaluate the 6-month efficacy of the therapeutic educational program for consolidation in Phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver and its affect on the level of moderate-to-sustained physical activity (\> 3 METs) in coronary patients in Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.; The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured in minutes per week.
Moderate-to-sustained physical activity in Controls	Month 6	The accelerometer will be used to evaluate the 6-month efficacy of the therapeutic educational program for consolidation in Phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver and its affect on the level of moderate-to-sustained physical activity (\> 3 METs) in coronary patients in Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.; The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured in minutes per week.

Secondary Outcome Measures

Name	Time	Method
Cholesterol in the Experimental Group	Month 6	mg/dL
Cholesterol in Controls	Month 6	mg/dL
Triglycerides in the Experimental Group	Month 6	mg/dL
Blood pressure in the Experimental Group	Month 6	mm Hg
Number of steps taken per week in the Experimental Group	Month 6	Number of steps taken per week recorded by the accelerometer
Blood pressure in Controls	Month 6	mm Hg
Modified Borg score in Controls	Month 6	The modified Borg dyspnea score uses a scale from 0 to 10 in which 0 represents no dyspnea and 10 represents maximal dyspnea. Scores are obtained at the end of the 6-minute walking test and reflect the maximum degree of dyspnea at any time during the walk test.
Abdominal circumference in Controls	Month 6	In cm
Aerobic capacity in the Experimental Group	Month 6	Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Moderate-to-sustained physical activity in the Experimental Group	Month 3	The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured with the accelerometer in minutes per week.
Moderate-to-sustained physical activity in Controls	Month 3	The amount of moderate-to-sustained physical activity (\> 3 METs) will be measured with the accelerometer in minutes per week.
Number of steps taken per week in Controls	Month 6	Number of steps taken per week recorded by the accelerometer
Modified Borg score in the Experimental Group	Month 6	The modified Borg dyspnea score uses a scale from 0 to 10 in which 0 represents no dyspnea and 10 represents maximal dyspnea. Scores are obtained at the end of the 6-minute walking test and reflect the maximum degree of dyspnea at any time during the walk test.
Time spent sitting/lying down per week in Controls	Month 6	Time spent sitting/lying down per week recorded by the accelerometer
Aerobic capacity in Controls	Month 6	Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
International Physical Activity Questionnaire Score in the Experimental Group	Month 6	The short form of the International Physical Activity Questionnaire measures physical activity over the previous week and assesses the types of intensity of physical activity, and sitting time to estimate total physical activity in MET-min/week and time spent sitting. For each category of activity a maximum of 21 hours of activity are permitted a week (3 hours X 7 days).To calculate MET-minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) is multiplied by the number of minutes the activity was carried out, and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET-minutes for that activity are 3.3 X 30 X 5=495 MET-minutes a week. The MET minutes achieved in each category (walking, moderate activity and vigorous activity) are then added together to get the total MET-minutes of physical activity per week.
International Physical Activity Questionnaire Score in Controls	Month 6	The short form of the International Physical Activity Questionnaire measures physical activity over the previous week and assesses the types of intensity of physical activity, and sitting time to estimate total physical activity in MET-min/week and time spent sitting. For each category of activity a maximum of 21 hours of activity are permitted a week (3 hours X 7 days).To calculate MET-minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) is multiplied by the number of minutes the activity was carried out, and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET-minutes for that activity are 3.3 X 30 X 5=495 MET-minutes a week. The MET minutes achieved in each category (walking, moderate activity and vigorous activity) are then added together to get the total MET-minutes of physical activity per week.
Time spent sitting/lying down per week in the Experimental Group	Month 6	Time spent sitting/lying down per week recorded by the accelerometer
Low-density lipoprotein in Controls	Month 6	mg/dL
High-density lipoprotein in the Experimental Group	Month 6	mg/dL
Abdominal circumference in the Experimental Group	Month 6	In cm
Low-density lipoprotein in the Experimental Group	Month 6	mg/dL
High-density lipoprotein in Controls	Month 6	mg/dL
Compliance with medication in the Experimental Group	Month 6	YES/NO
Mediterranean diet adherence test in Controls	Month 6	The MEDAS (Mediterranean diet Adherence Screener) score is a 14-point self-administered questionnaire used to assess adherence to a Mediterranean diet, based on consumption thresholds for 11 food groups (olive oil, vegetables, fruit, red meat, butter or cream, sweetened beverages, wine, legumes, fish, pastries and nuts), plus an additional question on preferential consumption of red or white meat. A score of 9 or over proves adherence to the Mediterranean diet.
Understanding barriers to motivation: Experimental group	Month 6	The main barriers to physical activity cited by patients, and the responses provided by the healthcare professional - peer helper as part of therapeutic education sessions will be identified. Qualitative research
Understanding barriers to motivation in Controls	Month 6	The main barriers to physical activity cited by patients, and the responses provided by the healthcare professional - peer helper as part of therapeutic education sessions will be identified. Qualitative research
Blood glucose levels in the Experimental Group	Month 6	mg/dL
Motivation for doing physical activity in Controls	Month 6	The EMAPS scale (Echelle de Motivation envers l'Activité Physique en contexte de Santé = Scale for Motivation for Physical Activity in the Context of Health).This is an 18-item questionnaire with scores from 1 to 7. Depending on the patient's answers to the questions, the type and extent of motivation are defined. Score 18 - 126
Triglycerides in Controls	Month 6	mg/dL
Compliance with medication in Controls	Month 6	YES/NO
Exercise Confidence Survey in the Experimental Group	Month 6	French version of the "Exercise Confidence Survey" for regular physical activity) according to Eeckhout et al. 2012. The ECS questionnaire measures perceived self-efficacy for regular physical activity. It has two dimensions in the Exercise Confidence Survey: "sticking to it" and "making time for exercise". The survey has 8 questions to be answered by "I Know I can" (1 point) "Maybe I can" (3 points) or "I Know I cannot" (5 points). (Sallis et al., 1996)
Exercise Confidence Survey in Controls	Month 6	French version of the "Exercise Confidence Survey" for regular physical activity) according to Eeckhout et al. 2012. The ECS questionnaire measures perceived self-efficacy for regular physical activity. It has two dimensions in the Exercise Confidence Survey: "sticking to it" and "making time for exercise". The survey has 8 questions to be answered by "I Know I can" (1 point) "Maybe I can" (3 points) or "I Know I cannot" (5 points). (Sallis et al., 1996)
Blood glucose levels in Controls	Month 6	mg/dL
Motivation for doing physical activity in the Experimental Group	Month 6	The EMAPS scale (Echelle de Motivation envers l'Activité Physique en contexte de Santé = Scale for Motivation for Physical Activity in the Context of Health).This is an 18-item questionnaire with scores from 1 to 7. Depending on the patient's answers to the questions, the type and extent of motivation are defined. Score 18 - 126
Mediterranean diet adherence test in the Experimental Group	Month 6	The MEDAS (Mediterranean diet Adherence Screener) score is a 14-point self-administered questionnaire used to assess adherence to a Mediterranean diet, based on consumption thresholds for 11 food groups (olive oil, vegetables, fruit, red meat, butter or cream, sweetened beverages, wine, legumes, fish, pastries and nuts), plus an additional question on preferential consumption of red or white meat. A score of 9 or over proves adherence to the Mediterranean diet.

Trial Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nimes, France