Borg Sabina, Öberg Birgitta, Nilsson Lennart, Söderlund Anne, Bäck Maria
Department of Medical and Health Sciences, Division of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.
Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
BMC Cardiovasc Disord. 2017 May 25;17(1):134. doi: 10.1186/s12872-017-0557-7.
To help patients with coronary artery disease (CAD) benefit from the positive health effects attained by exercise-based cardiac rehabilitation (CR), adherence to these programmes according to international guidelines is important. Strategies to increase adherence to exercise-based CR are mainly an unexplored area. The objective of this study is to investigate the effects of a behavioural medicine intervention in physiotherapy, containing goal-setting, self-monitoring and feedback, with the aim of improving rehabilitation outcomes for exercise-based CR, compared with usual care.
This is a randomised, controlled trial. A total of 160 patients with CAD will be included consecutively at the Coronary Care Unit at a university hospital in Sweden. Patients are randomised 1:1 using sealed envelopes to usual care or a behavioural medicine intervention in physiotherapy, in addition to usual care for 4 months. Outcome assessment at baseline, 4 and 12 months includes submaximal aerobic capacity (primary outcome), exercise adherence, muscle endurance, level of physical activity, biomarkers, anxiety and depression, health-related quality of life, patient enablement and self-efficacy (secondary outcomes).
This is the first study to evaluate the role of an integrated behavioural medicine intervention in exercise-based CR in the effects of rehabilitation outcomes. The results of this study will provide valuable information about the effect of these interventions in exercise-based CR and it has the potential to inform and assist in further treatment in secondary prevention for patients with CAD.
The study include all items from the World Health Organization Trial Registration Data Set.
NCT02895451, 2016-08-16, retrospectively registered.
为帮助冠心病（CAD）患者从基于运动的心脏康复（CR）所带来的积极健康影响中获益，按照国际指南坚持这些计划非常重要。提高对基于运动的CR的依从性的策略主要是一个尚未探索的领域。本研究的目的是调查物理治疗中行为医学干预（包括目标设定、自我监测和反馈）的效果，旨在与常规护理相比，改善基于运动的CR的康复结果。
这是一项随机对照试验。瑞典一家大学医院的冠心病监护病房将连续纳入总共160例CAD患者。使用密封信封将患者按1:1随机分配至常规护理组或物理治疗中的行为医学干预组，此外还进行4个月的常规护理。在基线、4个月和12个月时进行结果评估，包括次极量有氧运动能力（主要结果）、运动依从性、肌肉耐力、身体活动水平、生物标志物、焦虑和抑郁、健康相关生活质量、患者赋能和自我效能感（次要结果）。
这是第一项评估综合行为医学干预在基于运动的CR中对康复结果影响的作用的研究。本研究结果将提供有关这些干预措施在基于运动的CR中的效果的有价值信息，并且有可能为CAD患者二级预防中的进一步治疗提供信息和帮助。
该研究包括世界卫生组织试验注册数据集的所有项目。
NCT02895451，2016年8月16日，追溯注册。
