Clinical trial NCT05927363: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Cardiovascular Rehabilitation
Motivation
Physical Activity
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Moderate-to-sustained physical activity in the Experimental Group
timeFrame: Month 6
measure: Moderate-to-sustained physical activity in Controls
timeFrame: Month 6
Secondary outcomes:
measure: Moderate-to-sustained physical activity in the Experimental Group
timeFrame: Month 3
measure: Moderate-to-sustained physical activity in Controls
timeFrame: Month 3
measure: Number of steps taken per week in the Experimental Group
timeFrame: Month 0
measure: Number of steps taken per week in the Experimental Group
timeFrame: Month 3
measure: Number of steps taken per week in the Experimental Group
timeFrame: Month 6
measure: Number of steps taken per week in Controls
timeFrame: Month 0
measure: Number of steps taken per week in Controls
timeFrame: Month 3
measure: Number of steps taken per week in Controls
timeFrame: Month 6
measure: Time spent sitting/lying down per week in the Experimental Group
timeFrame: Month 0
measure: Time spent sitting/lying down per week in the Experimental Group
timeFrame: Month 3
measure: Time spent sitting/lying down per week in the Experimental Group
timeFrame: Month 6
measure: Time spent sitting/lying down per week in Controls
timeFrame: Month 0
measure: Time spent sitting/lying down per week in Controls
timeFrame: Month 3
measure: Time spent sitting/lying down per week in Controls
timeFrame: Month 6
measure: International Physical Activity Questionnaire Score in the Experimental Group
timeFrame: Month 0
measure: International Physical Activity Questionnaire Score in the Experimental Group
timeFrame: Month 3
measure: International Physical Activity Questionnaire Score in the Experimental Group
timeFrame: Month 6
measure: International Physical Activity Questionnaire Score in Controls
timeFrame: Month 0
measure: International Physical Activity Questionnaire Score in Controls
timeFrame: Month 3
measure: International Physical Activity Questionnaire Score in Controls
timeFrame: Month 6
measure: Blood pressure in the Experimental Group
timeFrame: Month 0
measure: Blood pressure in the Experimental Group
timeFrame: Month 3
measure: Blood pressure in the Experimental Group
timeFrame: Month 6
measure: Blood pressure in Controls
timeFrame: Month 0
measure: Blood pressure in Controls
timeFrame: Month 3
measure: Blood pressure in Controls
timeFrame: Month 6
measure: Modified Borg score in the Experimental Group
timeFrame: Month 0
measure: Modified Borg score in the Experimental Group
timeFrame: Month 3
measure: Modified Borg score in the Experimental Group
timeFrame: Month 6
measure: Modified Borg score in Controls
timeFrame: Month 0
measure: Modified Borg score in Controls
timeFrame: Month 3
measure: Modified Borg score in Controls
timeFrame: Month 6
measure: Abdominal circumference in the Experimental Group
timeFrame: Month 0
measure: Abdominal circumference in the Experimental Group
timeFrame: Month 3
measure: Abdominal circumference in the Experimental Group
timeFrame: Month 6
measure: Abdominal circumference in Controls
timeFrame: Month 0
measure: Abdominal circumference in Controls
timeFrame: Month 3
measure: Abdominal circumference in Controls
timeFrame: Month 6
measure: Aerobic capacity in the Experimental Group
timeFrame: Month 0
measure: Aerobic capacity in the Experimental Group
timeFrame: Month 3
measure: Aerobic capacity in the Experimental Group
timeFrame: Month 6
measure: Aerobic capacity in Controls
timeFrame: Month 0
measure: Aerobic capacity in Controls
timeFrame: Month 3
measure: Aerobic capacity in Controls
timeFrame: Month 6
measure: Cholesterol in the Experimental Group
timeFrame: Month 0
measure: Cholesterol in the Experimental Group
timeFrame: Month 3
measure: Cholesterol in the Experimental Group
timeFrame: Month 6
measure: Cholesterol in Controls
timeFrame: Month 0
measure: Cholesterol in Controls
timeFrame: Month 3
measure: Cholesterol in Controls
timeFrame: Month 6
measure: Low-density lipoprotein in the Experimental Group
timeFrame: Month 0
measure: Low-density lipoprotein in the Experimental Group
timeFrame: Month 3
measure: Low-density lipoprotein in the Experimental Group
timeFrame: Month 6
measure: Low-density lipoprotein in Controls
timeFrame: Month 0
measure: Low-density lipoprotein in Controls
timeFrame: Month 3
measure: Low-density lipoprotein in Controls
timeFrame: Month 6
measure: High-density lipoprotein in the Experimental Group
timeFrame: Month 0
measure: High-density lipoprotein in the Experimental Group
timeFrame: Month 3
measure: High-density lipoprotein in the Experimental Group
timeFrame: Month 6
measure: High-density lipoprotein in Controls
timeFrame: Month 0
measure: High-density lipoprotein in Controls
timeFrame: Month 3
measure: High-density lipoprotein in Controls
timeFrame: Month 6
measure: Triglycerides in the Experimental Group
timeFrame: Month 0
measure: Triglycerides in the Experimental Group
timeFrame: Month 3
measure: Triglycerides in the Experimental Group
timeFrame: Month 6
measure: Triglycerides in Controls
timeFrame: Month 0
measure: Triglycerides in Controls
timeFrame: Month 3
measure: Triglycerides in Controls
timeFrame: Month 6
measure: Blood glucose levels in the Experimental Group
timeFrame: Month 0
measure: Blood glucose levels in the Experimental Group
timeFrame: Month 3
measure: Blood glucose levels in the Experimental Group
timeFrame: Month 6
measure: Blood glucose levels in Controls
timeFrame: Month 0
measure: Blood glucose levels in Controls
timeFrame: Month 3
measure: Blood glucose levels in Controls
timeFrame: Month 6
measure: Compliance with medication in the Experimental Group
timeFrame: Month 0
measure: Compliance with medication in the Experimental Group
timeFrame: Month 3
measure: Compliance with medication in the Experimental Group
timeFrame: Month 6
measure: Compliance with medication in Controls
timeFrame: Month 0
measure: Compliance with medication in Controls
timeFrame: Month 3
measure: Compliance with medication in Controls
timeFrame: Month 6
measure: Motivation for doing physical activity in the Experimental Group
timeFrame: Month 0
measure: Motivation for doing physical activity in the Experimental Group
timeFrame: Month 3
measure: Motivation for doing physical activity in the Experimental Group
timeFrame: Month 6
measure: Motivation for doing physical activity in Controls
timeFrame: Month 0
measure: Motivation for doing physical activity in Controls
timeFrame: Month 3
measure: Motivation for doing physical activity in Controls
timeFrame: Month 6
measure: Exercise Confidence Survey in the Experimental Group
timeFrame: Month 0
measure: Exercise Confidence Survey in the Experimental Group
timeFrame: Month 3
measure: Exercise Confidence Survey in the Experimental Group
timeFrame: Month 6
measure: Exercise Confidence Survey in Controls
timeFrame: Month 0
measure: Exercise Confidence Survey in Controls
timeFrame: Month 3
measure: Exercise Confidence Survey in Controls
timeFrame: Month 6
measure: Mediterranean diet adherence test in the Experimental Group
timeFrame: Month 0
measure: Mediterranean diet adherence test in the Experimental Group
timeFrame: Month 3
measure: Mediterranean diet adherence test in the Experimental Group
timeFrame: Month 6
measure: Mediterranean diet adherence test in Controls
timeFrame: Month 0
measure: Mediterranean diet adherence test in Controls
timeFrame: Month 3
measure: Mediterranean diet adherence test in Controls
timeFrame: Month 6
measure: Understanding barriers to motivation: Experimental group
timeFrame: Month 0
measure: Understanding barriers to motivation: Experimental group
timeFrame: Month 3
measure: Understanding barriers to motivation: Experimental group
timeFrame: Month 6
measure: Understanding barriers to motivation in Controls
timeFrame: Month 0
measure: Understanding barriers to motivation in Controls
timeFrame: Month 3
measure: Understanding barriers to motivation in Controls
timeFrame: Month 6
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Nîmes University Hospital
name: Virginie VALLAYER
role: PRINCIPAL_INVESTIGATOR
References: