Homs Alexis F, Lachaux Robin, Vallayer Virginie, Oulad Chrif Karim, Croizer Marc, Eglin Isabelle, Pionnier Raphael, Chevallier Thierry, Belvisi Clarisse, Dupeyron Arnaud F
Department of Physical Medicine and Rehabilitation, CHU Nimes, University of Montpellier, Nimes, France
EuroMov Digital Health in Motion, University of Montpellier, IMT Mines Ales, Montpellier, France.
BMJ Open. 2025 Jun 6;15(6):e095196. doi: 10.1136/bmjopen-2024-095196.
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).
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.
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.
NCT05927363.
冠心病(CHD)患者在心血管康复后维持令人满意的身体活动(PA)水平是一个重要的公共卫生问题。然而,超过一半的患者长期无法维持推荐的PA水平。人们越来越关注在教育和研究环境中积极让健康专业人员和患者共同参与的认知行为干预措施。我们假设,由同伴与健康专业人员合作提供的个性化治疗教育计划(PTEP)可能有助于冠心病患者在参加心血管康复计划(CRP)后维持适当的PA水平。
我们设计了一项由健康专业人员和作为专家或同伴的患者联合开展的前瞻性随机对照试验(P-HEART-NER研究)。主要目标是评估PTEP对CRP结束6个月后通过加速度计测量的中度至剧烈PA客观水平的影响。次要目标包括:(1)评估干预对轻度PA和久坐时间(也通过加速度计测量)的影响;(2)评估心血管健康指标的变化,包括血压、腰围和血脂谱;(3)评估PA动机(使用面向健康的身体活动动机量表)、PA自我效能感(通过运动信心调查测量)和生活质量(EQ-5D-5L)的变化。患者将在心肌梗死后为期4周的2期CRP结束时入组。干预措施将分别在第2、4和5个月包括两次远程会诊和一次小组研讨会,每次均由一名同伴和一名健康专业人员共同提供。实施干预的同伴将是已参加2期CRP且依从性良好的患者,他们将接受健康专业人员和专家患者的动机增强和认知行为疗法培训。对照组将不完成PTEP。
法国地区伦理委员会法兰西岛CPP(参考编号CPPIDF1-2023-DI36-Cat2)已批准伦理许可。所有参与者将签署书面知情同意书。研究结果将在会议上公布并发表在同行评审期刊上。
NCT05927363。