Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
- Conditions
- Coronary Artery Disease
- Interventions
- Behavioral: Extended behavioral intervention
- Registration Number
- NCT02895451
- Lead Sponsor
- Linkoeping University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- Primary care event due to coronary artery disease and/or percutaneous coronary intervention (PCI) at the coronary care unit, Linköping University hospital
- Age <75 years
- Serious physical or psychological disease interfering with participation in exercise-based CR
- Inability to understand the Swedish language
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended behavioral intervention Extended behavioral intervention Specific goal-setting, self-monitoring and feed-back
- Primary Outcome Measures
Name Time Method Change from baseline aerobic exercise capacity (watts) at 4 months 4 months The test is performed on a bicycle ergometer according to the WHO-protocol with an increased workload of 25W every 4.5 minutes.The exercise test is discontinued at Borg RPE 17 and/or dyspnea 7 at Borg´s CR-10 scale.
- Secondary Outcome Measures
Name Time Method Adherence to dose of exercise 12 months Exercise diary
Change from baseline level of physical activity at 12 months 12 months Bouchard questionnaire
Adherence to dose in exercise 4 months exercise diary
Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months 4 months Muscle endurance test
Change from baseline unilateral isotonic heel lift (repetitions) at 4 months 4 months Muscle endurance test
Change from baseline anxiety score at 4 months 4 months Hospital Anxiety and Depression Scale (HADS)
Change from baseline depression score at 4 months 4 months Hospital Anxiety and Depression Scale (HADS)
Change from baseline self-efficacy score at 4 months 4 months Self Efficacy Exercise Scale (SEE-SV)
Change from baseline health-related quality of life score at 4 months 4 months EQ5D
Change from baseline level of physical activity at 4 months 4 months Bouchard questionnaire
Change from baseline aerobic exercise capacity (watts) at 12 months 12 months Submaximal exercise test on bicycle ergometer
Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months 12 months Muscle endurance test
Change from baseline unilateral isotonic heel lift (repetitions) at 12 months 12 months Muscle endurance test
Change from baseline anxiety score at 12 months 12 months Hospital Anxiety and Depression Scale (HADS)
Change from baseline depression score at 12 months 12 months Hospital Anxiety and Depression Scale (HADS)
Change from baseline self-efficacy score at 12 months 12 months Self Efficacy Exercise Scale (SEE-SV)
Change from baseline health-related quality of life score at 12 months 2 months EQ5D
Patient Enablement (score) 12 months Patient Enablement Instrument (PEI)
Trial Locations
- Locations (1)
Linkoeping University
🇸🇪Linkoeping, Sweden