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Randomized Controlled Trial
. 2017 May 25;17(1):134.
doi: 10.1186/s12872-017-0557-7.

The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial

Sabina Borg  1   2 , Birgitta Öberg  1 , Lennart Nilsson  3 , Anne Söderlund  4 , Maria Bäck  5
Affiliations
Randomized Controlled Trial

The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial

Sabina Borg et al. BMC Cardiovasc Disord. .

Abstract

Background: 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.

Methods: 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).

Discussion: 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.

Trial registration: The study include all items from the World Health Organization Trial Registration Data Set.

Trial registration number: NCT02895451, 2016-08-16, retrospectively registered.

Keywords: Coronary artery disease; Feedback; Goal-setting; Physical fitness; Physiotherapy; Self-efficacy; Self-monitoring.

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Figures

Fig. 1
Fig. 1
Overview of enrolment, interventions, and assessments
See this image and copyright information in PMC

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