Myocardial InfarctionP-HEARTNERNCT05927363
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.
A study testing Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership, Teleconsultation at 2 months and Teleconsultation at 4 months in people with Myocardial Infarction, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership, Teleconsultation at 2 months and Teleconsultation at 4 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2024to 9 Dec 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on the Physical Activity Level of Coronary Patients in Phase 3 of a Therapeutic Educational Consolidation Program Involving a "Patient Partner" Associated With a Healthcare Professional. A Randomized Controlled Trial.
Following myocardial infarction, cardiac rehabilitation has undeniable benefits on criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:
- immediate post-acute, in a cardiology department,
- active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
- 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.
Read the 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:
- immediate post-acute, in a cardiology department,
- active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
- 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.
- Conditions
- Myocardial Infarction
- Being tested
- Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership, Teleconsultation at 2 months, Teleconsultation at 4 months, Remote group education workshop, Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.
- Keywords
- Cardiovascular Rehabilitation, Motivation, Physical Activity
- Medical subject headings
- Myocardial Infarction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnershipOther
In the experimental group, patients benefit from the usual management as part of the phase 2 post-CR follow-up, with the provision of an information booklet on the benefits of physical activity, and a telephone contact in the event of any questions. In addition, they benefit from the "Consolidation therapeutic education program in phase 3 of CR associating a patient \& caregiver partnership, which consists of two teleconsultation sessions at 2 and 4 months, followed by a remote group education workshop co-facilitated by the patient and caregiver partnership at 5 months.
Discussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions.
Teleconsultation at 2 monthsOther
Discussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions.
Teleconsultation at 4 monthsOther
Discussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions.
Remote group education workshopOther
This remote workshop will be co-facilitated by the patient and caregiver partnership at 5 months
Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.Other
Patients are then randomly assigned to either the control group (usual management) or the experimental group (management with Patient and Caregiver partnership).
6-minute walk test and administers the modified Borg scale at its conclusion.Diagnostic test
What is a modified Borg scale? The Modified Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered following a six-minute walking test, one of the most common and frequently used measures to assess disease severity in patients with pulmonary arterial hypertension. Upon conclusion of the 6-minute walking test, the modified Borg scale will be recorded.
Biological check-upDiagnostic test
This check-up includes total cholesterol, LDL, HDL, triglycerides, HbA1c.
AccelerometerDevice
An accelerometer is given to the patient, with instructions to wear it for 7 days following the visit (it will then be returned by post).Pre-stamped "bubble" envelopes are given to the patient to return their accelerometer to the measurement points specified in the follow-up.
Administration of a logbookOther
The patient is given a logbook for daily monitoring of non-measurable physical activities, treatments and medical procedures carried out, as well as any intercurrent events.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Patients in Phase 3 of cardiac rehabilitation, undergoing the usual care provided. |
| Experimental Group | Experimental | 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. Receives: 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; Other: Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.; 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate-to-sustained physical activity in the Experimental Group
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.
Measured: Month 6
Moderate-to-sustained physical activity in Controls
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.
Measured: Month 6
Secondary outcomes (104)
Moderate-to-sustained physical activity in the Experimental Group
The amount of moderate-to-sustained physical activity (> 3 METs) will be measured with the accelerometer in minutes per week.
Measured: Month 3
Moderate-to-sustained physical activity in Controls
The amount of moderate-to-sustained physical activity (> 3 METs) will be measured with the accelerometer in minutes per week.
Measured: Month 3
Number of steps taken per week in the Experimental Group
Number of steps taken per week recorded by the accelerometer
Measured: Month 0
Number of steps taken per week in the Experimental Group
Number of steps taken per week recorded by the accelerometer
Measured: Month 3
Number of steps taken per week in the Experimental Group
Number of steps taken per week recorded by the accelerometer
Measured: Month 6
Number of steps taken per week in Controls
Number of steps taken per week recorded by the accelerometer
Measured: Month 0
Number of steps taken per week in Controls
Number of steps taken per week recorded by the accelerometer
Measured: Month 3
Number of steps taken per week in Controls
Number of steps taken per week recorded by the accelerometer
Measured: Month 6
Time spent sitting/lying down per week in the Experimental Group
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 0
Time spent sitting/lying down per week in the Experimental Group
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 3
Time spent sitting/lying down per week in the Experimental Group
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 6
Time spent sitting/lying down per week in Controls
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 0
Time spent sitting/lying down per week in Controls
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 3
Time spent sitting/lying down per week in Controls
Time spent sitting/lying down per week recorded by the accelerometer
Measured: Month 6
International Physical Activity Questionnaire Score in the Experimental Group
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.
Measured: Month 0
International Physical Activity Questionnaire Score in the Experimental Group
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.
Measured: Month 3
International Physical Activity Questionnaire Score in the Experimental Group
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.
Measured: Month 6
International Physical Activity Questionnaire Score in Controls
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.
Measured: Month 0
International Physical Activity Questionnaire Score in Controls
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.
Measured: Month 3
International Physical Activity Questionnaire Score in Controls
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.
Measured: Month 6
Blood pressure in the Experimental Group
mm Hg
Measured: Month 0
Blood pressure in the Experimental Group
mm Hg
Measured: Month 3
Blood pressure in the Experimental Group
mm Hg
Measured: Month 6
Blood pressure in Controls
mm Hg
Measured: Month 0
Blood pressure in Controls
mm Hg
Measured: Month 3
Blood pressure in Controls
mm Hg
Measured: Month 6
Modified Borg score in the Experimental Group
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.
Measured: Month 0
Modified Borg score in the Experimental Group
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.
Measured: Month 3
Modified Borg score in the Experimental Group
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.
Measured: Month 6
Modified Borg score in Controls
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.
Measured: Month 0
Modified Borg score in Controls
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.
Measured: Month 3
Modified Borg score in Controls
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.
Measured: Month 6
Abdominal circumference in the Experimental Group
In cm
Measured: Month 0
Abdominal circumference in the Experimental Group
In cm
Measured: Month 3
Abdominal circumference in the Experimental Group
In cm
Measured: Month 6
Abdominal circumference in Controls
In cm
Measured: Month 0
Abdominal circumference in Controls
In cm
Measured: Month 3
Abdominal circumference in Controls
In cm
Measured: Month 6
Aerobic capacity in the Experimental Group
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 0
Aerobic capacity in the Experimental Group
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 3
Aerobic capacity in the Experimental Group
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 6
Aerobic capacity in Controls
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 0
Aerobic capacity in Controls
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 3
Aerobic capacity in Controls
Aerobic capacity clinically measured by the 6-minute walking test (number of metres covered).
Measured: Month 6
Cholesterol in the Experimental Group
mg/dL
Measured: Month 0
Cholesterol in the Experimental Group
mg/dL
Measured: Month 3
Cholesterol in the Experimental Group
mg/dL
Measured: Month 6
Cholesterol in Controls
mg/dL
Measured: Month 0
Cholesterol in Controls
mg/dL
Measured: Month 3
Cholesterol in Controls
mg/dL
Measured: Month 6
Low-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 0
Low-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 3
Low-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 6
Low-density lipoprotein in Controls
mg/dL
Measured: Month 0
Low-density lipoprotein in Controls
mg/dL
Measured: Month 3
Low-density lipoprotein in Controls
mg/dL
Measured: Month 6
High-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 0
High-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 3
High-density lipoprotein in the Experimental Group
mg/dL
Measured: Month 6
High-density lipoprotein in Controls
mg/dL
Measured: Month 0
High-density lipoprotein in Controls
mg/dL
Measured: Month 3
High-density lipoprotein in Controls
mg/dL
Measured: Month 6
Triglycerides in the Experimental Group
mg/dL
Measured: Month 0
Triglycerides in the Experimental Group
mg/dL
Measured: Month 3
Triglycerides in the Experimental Group
mg/dL
Measured: Month 6
Triglycerides in Controls
mg/dL
Measured: Month 0
Triglycerides in Controls
mg/dL
Measured: Month 3
Triglycerides in Controls
mg/dL
Measured: Month 6
Blood glucose levels in the Experimental Group
mg/dL
Measured: Month 0
Blood glucose levels in the Experimental Group
mg/dL
Measured: Month 3
Blood glucose levels in the Experimental Group
mg/dL
Measured: Month 6
Blood glucose levels in Controls
mg/dL
Measured: Month 0
Blood glucose levels in Controls
mg/dL
Measured: Month 3
Blood glucose levels in Controls
mg/dL
Measured: Month 6
Compliance with medication in the Experimental Group
YES/NO
Measured: Month 0
Compliance with medication in the Experimental Group
YES/NO
Measured: Month 3
Compliance with medication in the Experimental Group
YES/NO
Measured: Month 6
Compliance with medication in Controls
YES/NO
Measured: Month 0
Compliance with medication in Controls
YES/NO
Measured: Month 3
Compliance with medication in Controls
YES/NO
Measured: Month 6
Motivation for doing physical activity in the Experimental Group
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
Measured: Month 0
Motivation for doing physical activity in the Experimental Group
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
Measured: Month 3
Motivation for doing physical activity in the Experimental Group
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
Measured: Month 6
Motivation for doing physical activity in Controls
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
Measured: Month 0
Motivation for doing physical activity in Controls
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
Measured: Month 3
Motivation for doing physical activity in Controls
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
Measured: Month 6
Exercise Confidence Survey in the Experimental Group
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)
Measured: Month 0
Exercise Confidence Survey in the Experimental Group
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)
Measured: Month 3
Exercise Confidence Survey in the Experimental Group
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)
Measured: Month 6
Exercise Confidence Survey in Controls
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)
Measured: Month 0
Exercise Confidence Survey in Controls
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)
Measured: Month 3
Exercise Confidence Survey in Controls
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)
Measured: Month 6
Mediterranean diet adherence test in the Experimental Group
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.
Measured: Month 0
Mediterranean diet adherence test in the Experimental Group
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.
Measured: Month 3
Mediterranean diet adherence test in the Experimental Group
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.
Measured: Month 6
Mediterranean diet adherence test in Controls
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.
Measured: Month 0
Mediterranean diet adherence test in Controls
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.
Measured: Month 3
Mediterranean diet adherence test in Controls
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.
Measured: Month 6
Understanding barriers to motivation: Experimental group
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
Measured: Month 0
Understanding barriers to motivation: Experimental group
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
Measured: Month 3
Understanding barriers to motivation: Experimental group
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
Measured: Month 6
Understanding barriers to motivation in Controls
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
Measured: Month 0
Understanding barriers to motivation in Controls
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
Measured: Month 3
Understanding barriers to motivation in Controls
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
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Jan 2024
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie VALLAYER, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927363
- Sponsor's protocol ID
- APIRES-NIMAO/2022/VV-01
- Acronym
- P-HEARTNER
- Status last verified
- Jan 2026
- First submitted
- 22 Jun 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual-level data, including accelerometry recordings and questionnaire responses
Publications
Homs AF, Lachaux R, Vallayer V, Oulad Chrif K, Croizer M, Eglin I, Pionnier R, Chevallier T, Belvisi C, Dupeyron AF. Effects of a remote therapeutic education programme involving peers and health professionals on physical activity in patients with coronary heart disease undergoing phase 3 cardiac rehabilitation: protocol for a single-centre randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e095196. doi: 10.1136/bmjopen-2024-095196.
PubMed 40480674
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Physical Activity Level of Coronary Patients in Phase 3 of a Therapeutic Educational Consolidation Program Involving a "Patient Partner" Associated With a Healthcare Professional. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05927363
- Acronym / sponsor ID
- P-HEARTNER / APIRES-NIMAO/2022/VV-01
- Conditions
- Myocardial Infarction
- Keywords
- Cardiovascular Rehabilitation, Motivation, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 9 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 3 Jul 2023 (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.
Following myocardial infarction, cardiac rehabilitation has undeniable benefits on criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:
- immediate post-acute, in a cardiology department,
- active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
- 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:
- immediate post-acute, in a cardiology department,
- active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Patients in Phase 3 of cardiac rehabilitation, undergoing the usual care provided. |
| Experimental Group | Experimental | 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, Other: Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score., 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 logbookPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnershipIn the experimental group, patients benefit from the usual management as part of the phase 2 post-CR follow-up, with the provision of an information booklet on the benefits of physical activity, and a telephone contact in the event of any questions. In addition, they benefit from the "Consolidation therapeutic education program in phase 3 of CR associating a patient \& caregiver partnership, which consists of two teleconsultation sessions at 2 and 4 months, followed by a remote group education workshop co-facilitated by the patient and caregiver partnership at 5 months. Discussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions. | Other | Experimental Group |
| Teleconsultation at 2 monthsDiscussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions. | Other | Experimental Group |
| Teleconsultation at 4 monthsDiscussions during teleconsultations will be recorded to identify the main barriers to physical activity mentioned by patients, and the responses provided by the healthcare professional-peer helper pair during the therapeutic education sessions. | Other | Experimental Group |
| Remote group education workshopThis remote workshop will be co-facilitated by the patient and caregiver partnership at 5 months | Other | Experimental Group |
| Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.Patients are then randomly assigned to either the control group (usual management) or the experimental group (management with Patient and Caregiver partnership). | Other | Experimental Group |
| 6-minute walk test and administers the modified Borg scale at its conclusion.What is a modified Borg scale? The Modified Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered following a six-minute walking test, one of the most common and frequently used measures to assess disease severity in patients with pulmonary arterial hypertension. Upon conclusion of the 6-minute walking test, the modified Borg scale will be recorded. | Diagnostic test | Experimental Group |
| Biological check-upThis check-up includes total cholesterol, LDL, HDL, triglycerides, HbA1c. | Diagnostic test | Experimental Group |
| AccelerometerAn accelerometer is given to the patient, with instructions to wear it for 7 days following the visit (it will then be returned by post).Pre-stamped "bubble" envelopes are given to the patient to return their accelerometer to the measurement points specified in the follow-up. | Device | Experimental Group |
| Administration of a logbookThe patient is given a logbook for daily monitoring of non-measurable physical activities, treatments and medical procedures carried out, as well as any intercurrent events. | Other | Experimental Group |
Primary outcome
Moderate-to-sustained physical activity in the Experimental Group
Time frame: 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
Time frame: 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.
104 secondary outcomes
Moderate-to-sustained physical activity in the Experimental Group
Time frame: Month 3
Moderate-to-sustained physical activity in Controls
Time frame: Month 3
Number of steps taken per week in the Experimental Group
Time frame: Month 0
Number of steps taken per week in the Experimental Group
Time frame: Month 3
Number of steps taken per week in the Experimental Group
Time frame: Month 6
Number of steps taken per week in Controls
Time frame: Month 0
Number of steps taken per week in Controls
Time frame: Month 3
Number of steps taken per week in Controls
Time frame: Month 6
Time spent sitting/lying down per week in the Experimental Group
Time frame: Month 0
Time spent sitting/lying down per week in the Experimental Group
Time frame: Month 3
Time spent sitting/lying down per week in the Experimental Group
Time frame: Month 6
Time spent sitting/lying down per week in Controls
Time frame: Month 0
Time spent sitting/lying down per week in Controls
Time frame: Month 3
Time spent sitting/lying down per week in Controls
Time frame: Month 6
International Physical Activity Questionnaire Score in the Experimental Group
Time frame: Month 0
International Physical Activity Questionnaire Score in the Experimental Group
Time frame: Month 3
International Physical Activity Questionnaire Score in the Experimental Group
Time frame: Month 6
International Physical Activity Questionnaire Score in Controls
Time frame: Month 0
International Physical Activity Questionnaire Score in Controls
Time frame: Month 3
International Physical Activity Questionnaire Score in Controls
Time frame: Month 6
Blood pressure in the Experimental Group
Time frame: Month 0
Blood pressure in the Experimental Group
Time frame: Month 3
Blood pressure in the Experimental Group
Time frame: Month 6
Blood pressure in Controls
Time frame: Month 0
Blood pressure in Controls
Time frame: Month 3
Blood pressure in Controls
Time frame: Month 6
Modified Borg score in the Experimental Group
Time frame: Month 0
Modified Borg score in the Experimental Group
Time frame: Month 3
Modified Borg score in the Experimental Group
Time frame: Month 6
Modified Borg score in Controls
Time frame: Month 0
Modified Borg score in Controls
Time frame: Month 3
Modified Borg score in Controls
Time frame: Month 6
Abdominal circumference in the Experimental Group
Time frame: Month 0
Abdominal circumference in the Experimental Group
Time frame: Month 3
Abdominal circumference in the Experimental Group
Time frame: Month 6
Abdominal circumference in Controls
Time frame: Month 0
Abdominal circumference in Controls
Time frame: Month 3
Abdominal circumference in Controls
Time frame: Month 6
Aerobic capacity in the Experimental Group
Time frame: Month 0
Aerobic capacity in the Experimental Group
Time frame: Month 3
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 23 Jan 2026.
- Background: PubMed 40480674Homs AF, Lachaux R, Vallayer V, Oulad Chrif K, Croizer M, Eglin I, Pionnier R, Chevallier T, Belvisi C, Dupeyron AF. Effects of a remote therapeutic education programme involving peers and health professionals on physical activity in patients with coronary heart disease undergoing phase 3 cardiac rehabilitation: protocol for a single-centre randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e095196. doi: 10.1136/bmjopen-2024-095196.
- Individual participant dataSharing planned: Yes. Anonymized individual-level data, including accelerometry recordings and questionnaire responses
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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.
Virginie VALLAYER principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership, Teleconsultation at 2 months and Teleconsultation at 4 months in people with Myocardial Infarction, run by Centre Hospitalier Universitaire de Nīmes 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 6 inclusion and 6 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 23 Jan 2026. 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?
Moderate-to-sustained physical activity in the Experimental Group (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927363, which also lists 1 linked publication.
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 23 Jan 2026.