Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of an extended behavioral
      intervention in exercise-based CR for improvement of physical capacity, adherence,
      psychological and physiological parameters, compared with usual care.
    

Detailed description: 
      Consecutive patients will be included at the coronary care unit (CCU), Linköping University
      Hospital, Sweden. Physiotherapists ask patients for informed consent at the CCU and book an
      appointment at the exercise-based CR 2-3 weeks after discharge for baseline tests. After
      baseline testing patients will be randomized to either extended intervention or routine care.
      Randomization will be stratified by submaximal exercise capacity. Patients randomized to the
      extended intervention group receive an additional appointment to a physiotherapist within a
      week. Thereafter patients in both groups start the exercise-based CR program, including
      aerobic exercise and resistance exercise, 3 times/week for 16 weeks, according to
      international guidelines for exercise-based CR.

      The extended intervention is based on components from behavioral medicine including: specific
      goal-setting, self-monitoring and feed-back.

      Changes in the endpoint variables will be measured from baseline to first (16 weeks at end of
      intervention) and second (12 months after index event) follow-up visits.

      Sample size calculations are based on previous clinical data from a similar exercise-based CR
      setting (n=50) on differences in aerobic exercise capacity measured by submaximal exercise
      test (watts) before vs after finished exercise-based CR. With a power of 80% and a two-sided
      significance level of p<0.05 and least mean difference at 10 watts (SD 20 watts) and a
      calculated loss of follow-up of 20%, the estimated sample size is 160 patients.
    

Intervention name(s): Extended behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): The exercise goal is set in liaison between the patient and the physiotherapist, based on activities and target behaviors that the patient thinks is relevant and important. The patients are asked to self-monitor the defined exercise goal by completing an exercise diary. The exercise diary includes specification of the performed exercise dose (frequency, intensity and duration). The exercise diary is followed up by a physiotherapist every third week by a phone call or a personal meeting. Visual feed-back on the performed dose of exercise is given once by accelerometry. At end of intervention (16 weeks) the patient is offered a follow-up meeting with the physiotherapist to discuss a long-term exercise goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise-based cardiac rehabilitation; Physical capacity; Adherence; Behavioral medicine