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.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership	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.
OTHER	Teleconsultation at 2 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	Teleconsultation at 4 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	Remote group education workshop	This remote workshop will be co-facilitated by the patient and caregiver partnership at 5 months
OTHER	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).
DIAGNOSTIC_TEST	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	Biological check-up	This check-up includes total cholesterol, LDL, HDL, triglycerides, HbA1c.
DEVICE	Accelerometer	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.
OTHER	Administration of a logbook	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.

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2023-07-03
• Last updated: 2026-01-23

Locations

1 site across 1 country: France