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.

NCT05927363 | Completed

• 1 other identifier: APIRES-NIMAO/2022/VV-01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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. 1.immediate post-acute, in a cardiology department,
2. 2.active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
3. 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.

Conditions

Myocardial Infarction

Keywords

Cardiovascular Rehabilitation; Motivation; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Month 6

Secondary Outcomes (104)

• Moderate-to-sustained physical activity in the Experimental Group

  Month 3

• Moderate-to-sustained physical activity in Controls

  Month 3

• Number of steps taken per week in the Experimental Group

  Month 0

• Number of steps taken per week in the Experimental Group

  Month 3

• Number of steps taken per week in the Experimental Group

  Month 6

Study Arms (2)

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.

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

Interventions

Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership OTHER

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.

Experimental Group

Teleconsultation at 2 months OTHER

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.

Experimental Group

Accelerometer DEVICE

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.

Experimental Group

Teleconsultation at 4 months OTHER

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.

Experimental Group

Remote group education workshop OTHER

This remote workshop will be co-facilitated by the patient and caregiver partnership at 5 months

Experimental Group

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.

Experimental Group

Biological check-up DIAGNOSTIC_TEST

This check-up includes total cholesterol, LDL, HDL, triglycerides, HbA1c.

Experimental Group

Administration of a logbook OTHER

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.

Experimental Group

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).

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30900, France

Location

Related Publications (1)

• 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.

  PMID: 40480674 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Motor Activity

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Intervention Hierarchy (Ancestors)

Exercise Test; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Virginie VALLAYER

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know whether they have been randomized to the group receiving the usual, standard rehabilitation or the group following the Therapeutic Consolidation Educational Program Involving a "Patient Partner" Associated With a Healthcare Professional.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 3, 2023
• Study Start: January 12, 2024
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After completion of the primary analysis
• Access Criteria: Upon reasonable request. Requests should be directed to the study's principal investigator and will require a data access agreement, in accordance with applicable ethical and data protection regulations

Locations

FR (1)