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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Virginie VALLAYER · Nîmes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2025-12-09
Completion
2025-12-09

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05927363 on ClinicalTrials.gov