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Abstract
Introduction Maintaining a satisfactory level of physical activity (PA) after cardiovascular rehabilitation in patients with coronary heart disease (CHD) is an important public health issue. However, more than half of patients do not maintain recommended levels of PA in the long term. There is growing interest in the use of cognitive-behavioural interventions that actively involve both health professionals and patients in education and research settings. We hypothesise that a personalised therapeutic education programme (PTEP) delivered by peers in collaboration with health professionals may help patients with CHD maintain appropriate levels of PA after participation in a cardiovascular rehabilitation programme (CRP).
Methods and analysis We designed a prospective randomised controlled trial (the P-HEART-NER study) conducted jointly by health professionals and patients as experts or peers. The primary objective is to assess the impact of PTEP on objective levels of moderate to vigorous PA—measured by accelerometers—6 months after cessation of CRP. The secondary objectives are (1) to assess the impact of the intervention on light PA and sedentary time (also measured by accelerometry), (2) to evaluate changes in cardiovascular health indicators, including blood pressure, waist circumference and lipid profile, (3) to assess changes in motivation towards PA (using the Motivation Scale Towards Health-Oriented Physical Activity), PA self-efficacy (measured by the Exercise Confidence Survey) and quality of life (EQ-5D-5L). Patients will be enrolled at the end of a 4-week phase 2 CRP after a myocardial infarction. The intervention will consist of two teleconsultations and a group workshop at 2, 4 and 5 months, respectively, each jointly delivered by a peer and a health professional. The peers who will deliver the intervention will be patients who have participated in a phase 2 CRP with good compliance and who will be trained in motivational enhancement and cognitive behavioural therapies by health professionals and expert patients. The control group will not complete the PTEP.
Ethics and dissemination Ethical approval was granted by the French regional ethics committee CPP Ile de France (Ref CPPIDF1-2023-DI36-Cat2). All participants will sign a written informed consent form. The results will be presented at conferences and published in peer-reviewed journals.
Trial registration number NCT05927363.
- Exercise
- Patient Participation
- Coronary heart disease
- REHABILITATION MEDICINE
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The level of physical activity will be measured objectively using accelerometers.
Patients have been involved since the conception and will enable the practical implementation of the study.
Peers will be trained by expert patients and health professionals to deliver motivational and cognitive–behavioural intervention.
Homogeneity of the intervention and feasibility will be the main challenges to be overcome.
The study is not blinded due to the nature of the intervention, which could introduce bias in the outcomes.
Introduction
Although there have been significant advances in the diagnosis and treatment of coronary heart disease (CHD) over the last 60 years, it remains one of the leading causes of death worldwide.1 People with a history of CHD have a higher risk of suffering a heart event in the future.2 To address this elevated risk, cardiac rehabilitation programmes (CRPs) have been developed as a secondary prevention strategy aimed at reducing the likelihood of recurrent cardiac events.3 CRP can be divided into three phases. Phase 1 focuses on early recovery while the patient is still hospitalised. Phase 2 is a secondary prevention programme that consists of increasing the patient’s physical fitness through structured exercise and modifying cardiovascular risk factors under medical supervision. Phase 2 of CRP has shown undeniable benefits in terms of serious outcomes such as cardiovascular mortality and a decrease in rehospitalisation rates, with a high level of scientific evidence demonstrated,3 and is now considered as the standard of care.4 Finally, phase 3 occurs when the patient returns to an active life after completing a CRP phase 2.5 One of the biggest challenges of CRP phase 3 is to achieve sustainable changes in physical activity (PA) practice, with a target of at least 150 min per week of moderate-intensity exercise.6 Moderate-to-vigorous PA has been consistently associated with improved cardiovascular outcomes in patients with CHD, including reduced morbidity, mortality and recurrence of events.7 8 These benefits support its relevance as a clinically meaningful and achievable target for post-MI populations.6
It has been reported that only 20–40% of patients with CHD remain physically active 6 months after completing a CRP.9 10 Patients often face physical and psychological barriers in daily life that make it difficult for them to maintain regular PA routines.11 Some patients have difficulty remembering discharge instructions, while others discontinue their prescribed exercise programmes due to factors such as comorbidities, lack of time, financial constraints or other personal challenges.11 12 It is important to recognise and systematically address these potential personal barriers but also to set clear goals for PA.11 To address the challenges in maintaining PA after CRP phase 2, several interventions have been assessed in the third phase, including support booklets, smartphone apps, written exercise plans, exercise diaries and supervised activity programmes.13 Most interventions reported notable improvements in PA based on self-reports, but these may be influenced by substantial assessment bias.9 Few studies used objective and validated measures of PA, such as accelerometry, and there was limited evidence of benefit in terms of maintenance of PA after 6 months, which is commonly used as a long-term assessment criterion.13
The lack of regular support and motivation could be a major reason for the decline in activity levels, but it also seems important to establish a positive, patient-centred relationship to adapt to each patient’s specific situation.14 15 To this end, the joint participation of a health professional and a former patient acting as a peer supporter for other patients seems to be of interest,16 as shared experiences and mutual support can foster motivation and provide a deeper understanding of the challenges associated with behaviour change in the context of each patient.17 18 Although peer involvement appears to be an interesting means of promoting health-enhancing PA,19 its effectiveness in patients with CHD remains to be fully characterised. Previous studies have shown encouraging results on rehabilitation adherence and self-reported outcomes,20 21 but none have evaluated structured peer interventions using objective PA measures such as accelerometry in a randomised controlled trial.
The aim of our study is to evaluate the impact of a personalised therapeutic education programme (PTEP) delivered by peers in collaboration with health professionals on objective levels of moderate to vigorous PA, at 6 months after CRP phase 2 cessation.
Methods and analysis
Study design
The P-HEART-NER study is a prospective, single-centre, randomised, controlled, open-label trial conducted by health professionals in collaboration with former patients acting as peer supporters, and involving new patients as participants. Recruitment commenced in January 2024, and the study is expected to conclude by March 2026. After signing an informed consent form, participants will be randomly assigned 1.1 to the intervention group with peers or the control group. All peers will also sign an informed consent form and a confidentiality agreement. This trial is registered on ClinicalTrials.gov (NCT05927363).
Patients
Adults with an established diagnosis of CHD, who fully participated in phase 2 of CRP at the University Hospital of Nimes, will be recruited. Inclusion and exclusion criteria are listed in table 1.
Inclusion and exclusion criteria
Interventions
Recruitment and training of peers
The peers will be recruited from patients who have completed phase 2 of the CRP at the University Hospital of Nimes and who continue to engage in PA, exercising at least 150 min per week at moderate intensity. In addition, they should agree to carry out three motivational sessions lasting 30–45 min by videoconference with at least four to six patients within 6 months of patient recruitment. Patients with psychiatric disorders, who are not computer literate or who lack suitable equipment, will not be recruited as peers.
The peers will be trained in three half-day interactive sessions organised by the cardiac rehabilitation department and the therapeutic patient education unit of the University Hospital of Nimes, based on a co-led training model previously developed and adapted to our local context.16 These sessions, jointly designed and led by expert patients (KOC and MC) and healthcare professionals (RL, CB, IE, AFH), will allow peers to engage in the research project, learn to interact with other patients and share their experiences, and recognise the boundary between knowledge sharing and medical advice. They will also be introduced to motivational enhancement and behaviour change techniques. Additionally, they will participate in periodic debriefings with the study team to address any challenges encountered, reinforce key principles and ensure consistent delivery of the intervention. If needed, they will have direct access to a designated member of the research team for support. Peers will be compensated for each teleconsultation conducted.
Description of the intervention
Participants in the experimental group will benefit from a PTEP, delivered by peers in collaboration with health professionals, consisting of three teleconsultations over a 6-month period, 2, 4 and 5 months after their discharge from the cardiac rehabilitation unit where they will complete their CRP. The intervention is informed by the principles of self-determination theory22 and social cognitive theory23 and employs a cognitive–behavioural approach incorporating motivational interviewing techniques (evocation, collaboration and promotion of autonomy) to enhance motivation, confidence and behavioural skills within a supportive, collaborative environment that fosters active patient engagement and peer-led role modelling. A summary of the session objectives, timing and delivery methods is presented in table 2.
Summary of the intervention: personalised therapeutic education programme, delivered jointly by peers and health professionals
In the control group, participants will follow the usual care and will not take part in the PTEP. The flow chart of the study is shown in figure 1.
Flow chart of the study design. CRP, cardiac rehabilitation programme; PTEP: personalised therapeutic education programme.
Objectives
Primary research aim
The primary aim is to evaluate the impact of a PTEP, conducted by peers in collaboration with health professionals, on objective moderate to vigorous PA, at 6 months after completion of CRP phase 2.
Primary research outcome
The primary outcome is the time spent in moderate to vigorous PA, expressed in minutes per week. PA intensity will be assessed using the ActiGraph GT3X+ accelerometer (ActiGraph, model GT3X+, Manufacturing Technology, Pensacola, Florida, USA), which is validated in the literature.24 25 Participants will wear the device on their hip for 7 consecutive days26 at baseline, 3 months and 6 months. This version of the accelerometer provides raw acceleration data expressed in units of gravity (1 g=9.81 m/s2) from the three measurement axes. This raw data will then be converted into a single measure of body acceleration, the magnitude vector. The latter is taken into account and subtracted by the gravity value (g) as 
– 1 referring to the ENMO (‘Euclidian Norm Minus One’) method.27 The result is then expressed in milligravity (mg), where 1000 mg=9.81 m/s². This signal can then be processed via an open-source programme using the R-package GGIR software.28 This software facilitates data processing, the detection of periods when the device is not worn, of activities that are not due to human activity, or the quantification of time spent in different intensities of PA.27 29 30
It is necessary to establish thresholds for the assessment of PA, defined according to the age of the patient and the attachment sites of the device.31–33 These thresholds are based on the acceleration measured in milligravity (mg) and allow the definition of inactivity (<1.5 Metabolic Equivalent Task (MET)), light intensity PA (between 1.5 and 3 METs), moderate intensity PA (between 3 and 6 METs) and vigorous PA (over 6 METs). The thresholds for hip localisation, based on the existing literature, are shown in table 3. The primary outcome will be calculated as the sum of time spent in both moderate and vigorous intensity zones.
Thresholds with ActiGraph GT3X+ and GGIR package to define levels of physical activity
Sample size estimation
To estimate the number of subjects needed, we relied on the results of a similarly designed pilot study,34 which evaluated a programme of motivational support for PA in coronary patients in phase 3 of the CRP compared with usual care. The main outcome measure was the same as the one we will use; however, it was only assessed at 8 weeks (short-term). The effect size of the difference in change between groups from this trial, with which we can compare, can be estimated with a Cohen’s d of 0.65. With an alpha risk of 0.05 and a power of 80%, the number of subjects required per group is 38. With an estimated dropout rate of around 10%, 42 patients per group would have to be included, that is, a total of 84 patients.
Secondary research aims and outcomes
To evaluate the effects of PTEP on moderate to vigorous PA levels at 3 months, on light PA levels at 3 and 6 months, on the number of daily steps and on sedentary behaviour: time spent at light and moderate and vigorous PA intensity during the week will be assessed using the accelerometers and the R-package GGIR at 3 and 6 months.28 The number of daily steps and the total sedentary time (hours per day) will be determined from the raw accelerometer signal (table 2).
To assess the impact of PTEP on subjective PA levels, measured with the International Physical Activity Questionnaire (IPAQ) at 3 and 6 months. This questionnaire measures PA in the previous week and assesses the type and intensity of PA, and sitting time to estimate total PA in MET-min/week and time spent sitting.35 Although accelerometry is the primary tool for quantifying PA, IPAQ provides additional insight into participants’ perceptions and subjective recall of their activity. It also allows comparison with self-reported data used in previous studies.
To measure the effect of PTEP on cardiovascular health indicators. Blood pressure, body weight and waist circumference will be measured at the 3- and 6-month consultations. Participants will complete a 6- minute walk test to clinically assess aerobic capacity and endurance,36 and at the end of the test will rate their degree of dyspnoea using the modified Borg dyspnoea score at the end of the test.37 Finally, after 6 months, blood tests will be performed to measure triglycerides, high- and low-density lipoproteins and total cholesterol.
To evaluate the effect of PTEP on motivation and perceived self-efficacy for PA. Motivation for doing PA will be assessed with the Motivation Scale Towards Health-Oriented Physical Activity.38 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. Perceived self-efficacy for PA will be evaluated with the French version of the ‘Exercise Confidence Survey’ for regular PA.39 It has two dimensions in the Exercise Confidence Survey: ‘sticking to it’ and ‘making time for exercise’. The survey has eight questions to be answered by ‘I Know I can’ (1 point), ‘Maybe I can’ (3 points) or ‘I Know I cannot’ (5 points).
To determine the impact of PTEP on quality of life, assessed with the EQ-5D-5L questionnaire. It is a standardised instrument consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each with five levels of severity, designed to provide a comprehensive assessment of a patient’s health status.40
To understand the main barriers to practising PA cited by patients: all teleconsultations conducted in the intervention group—between participants, peers and health professionals—will be audio recorded, subject to patient agreement. These recordings will serve as the basis for a qualitative study. The recordings will be fully transcribed and analysed using a thematic analysis with an inductive, grounded theory approach.41 The aim is to identify recurring themes such as barriers to PA and the nature of the support provided by peers and professionals. Codes and categories will be derived from the data, without applying a predefined analytical grid.
To evaluate the modification in the adherence to the Mediterranean diet, assessed as an exploratory secondary outcome using the Mediterranean diet Adherence Screener score,42 a 14-point self-administered questionnaire 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. Although dietary habits are not the primary focus of the intervention, peer-led support may indirectly influence broader health behaviours, including diet, in line with the holistic objectives of cardiac rehabilitation.
All participants will be evaluated at baseline, 3 months and 6 months, at a consultation by an investigator who is blinded to the group allocation.
Statistical analysis
Feasibility and recruitment
Around 250 patients are following a CRP in our department every year, most of them for CHD. In the run-up to the study, we estimated that more than 50% of the patients in our active file would meet the eligibility criteria (some patients are already participating in interventional cardiological studies, so they cannot be included in another interventional study). However, the actual inclusion rate will also depend on patient consent.
Randomisation
Participants will be randomised after eligibility confirmation and informed consent, using a centralised, secure web-based system developed for this study. The allocation sequence is generated by an independent methodologist using SAS software V. 9.4 (SAS Institute, Cary, North Carolina, USA). No stratification or variable block sizes are used. Randomisation is performed by a clinical research associate who is not involved in participant recruitment and is blinded to group allocation prior to assignment. Allocation concealment is ensured through system security and centralised control.
Statistical analysis plan
Descriptive analyses
An initial analysis will be carried out to describe the characteristics of the patients on admission. Quantitative variables will be described by their number, mean, SD, median, first and third quartiles, extreme values (minimum and maximum) and missing data. Qualitative variables will be described by their number and percentage. The comparability of the two randomisation groups will be checked for all initial characteristics that could influence the results. If one or more parameters are not comparable, an adjustment will be made for these parameters to compare the different results between the groups.
Primary outcome analysis
The duration of moderate to vigorous PA after 6 months will be compared between groups using a Student’s t-test or a Mann-Whitney U-test (depending on the distribution) on an intention-to-treat basis. If statistically significant baseline differences are found between groups after randomisation, a sensitivity analysis using multivariate linear regression will be performed to account for potential confounders (with transformation of the dependent variable, if necessary, to ensure normality of the distribution and homoscedasticity of the model residuals). Several potential confounders were identified a priori, including demographic variables (age, sex, Body Mass Index), socioeconomic status (educational level, annual household income, living environment), clinical characteristics (Charlson Comorbidity Index,43 presence of left ventricular dysfunction, clinical signs of heart failure, history of depressive episode) and baseline plans for PA after phase 2 of CRP.
Secondary outcomes analyses
The quantitative secondary outcomes at 3 and 6 months will be analysed using the same methods as described for the primary endpoint. The changes in quality of life at 3 and 6 months will be analysed using a linear mixed model with subject-specific random intercepts. The model’s dependent variable will be the value of the EQ-5D-5L score. The fixed effects entered into the model will be assessment time (D0, M3, M6), the randomisation arm and the interaction between the time of assessment and the randomisation arm.
Handling of missing data
If applicable, we will perform sensitivity analyses with multiple imputations. The imputations will be performed using a Markov chain Monte Carlo method, and 15 imputation cycles will be performed. Our outcome measures will be analysed independently for each of the imputed datasets. These results will be used to estimate the final parameters and their SD.
Ethics
The study will be conducted in accordance with the Declaration of Helsinki and the recommendations of good clinical practice. The study protocol was approved by the regional medical ethics committee (‘Comité de Protection des Personnes Ile-de-France I’, RCB reference: CPPIDF1-2023-DI36-Cat2). Written informed consent will be signed by all study participants prior to randomisation. An example of the consent form is provided as online supplemental material. All peers will also sign a consent form and a confidentiality agreement.
Supplemental material
Patient and public Involvement
Our two expert patients have contributed to the design of this study and will be involved in all phases, including training peer helpers and promoting research. Through the training of health professionals and expert patients, peer helpers will adopt an appropriate attitude that will enable patients to find their own resources to overcome barriers to returning to PA.
Dissemination
The dissemination plans for the results include presentations at conferences and publication in a peer-reviewed journal. Updates on the randomised trial will be available on ClinicalTrials.gov. All patients will be informed that the results will be accessible upon request.
Discussion
Insufficient PA after myocardial infarction in patients with CHD is associated with numerous negative consequences, including recurrence of the disease, the need for emergency hospitalisation and, in some cases, death.1 Despite these risks, failure to change lifestyle habits—particularly with regard to PA and sedentary behaviour—is common.11 Various interventions to improve PA have been tested, but results have been inconsistent.13 This may be due to a lack of personalised interventions and insufficient patient-centred approaches. In addition, few studies have objectively measured the duration and intensity of PA in these populations.
A key strength of this study is the inclusion of peers alongside health professionals in the delivery of the PTEP motivational enhancement intervention. The use of trained peers to increase motivation has been used successfully for other chronic conditions that require self-management.17 44 There is also evidence that patients perceive peers with similar conditions as more credible than healthcare professionals when receiving behavioural interventions.45 46 In our study, expert patients were actively involved from the design phase to the training of peers, which could provide an important evidence base for patient involvement in behavioural interventions for people with CHD. It can also serve as a model for the potential role of patients in research projects, while cardiovascular research seems to lag behind other areas in the level of patient involvement and awareness of clinical trials.47
There are several limitations to this study. First, for practical reasons, the peer training process is relatively short, which may lead to variation in the effectiveness of different peers and professionals in delivering the intervention. However, the use of structured targets for each teleconsultation and the involvement of two people in delivering the intervention should help to ensure a consistent quality of care. Another limitation is the absence of long-term follow-up beyond the 6-month postintervention period, which limits the ability to assess the sustainability of the intervention’s effects. In addition, the generalisability of the results may be limited as those who agree to participate in the study may already be at lower risk of reduced PA. Nevertheless, all patients participating in the cardiac rehabilitation programme will be informed in detail about the study to ensure transparency and will be proposed to participate.
In summary, this study will evaluate the effects of a motivational and cognitive-behavioural reinforcement intervention, designed and delivered jointly by patients and health professionals, aimed at encouraging patients to achieve the recommended levels of moderate to vigorous PA in their daily lives. The study also aims to shed light on the barriers to PA in this population and explore possible strategies to overcome them.
Ethics statements
Patient consent for publication
References
Footnotes
Contributors AFH, VV, RL, KOC, MC, IE and CB participated in the design of the study, will train peers. AFH, RL, KOC, MC and CB wrote the study protocol. RL and CB will collect data. RL and RP will analyse accelerometric data. TC set up a statistical analysis plan and determined sample size. RP and TC will help perform statistical analysis. RL, CB, KOC, MC and AFD critically revised the manuscript. AFH is the guarantor of this article.
Funding This research will be supported by Groupement Interrégional de Recherche Clinique et d’Innovation Sud-Ouest Outre-Mer Hospitalier (APIRES 2022) and by Nimes University Hospital (NIMAO). Funders will not influence the execution, analysis or publication of results.
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.