Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)

Linköping University (LiU)

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Behavioral: Extended behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02895451

Dnr: 2015/209-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Serious physical or psychological disease interfering with participation in exercise-based CR
• Inability to understand the Swedish language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Extended behavioral intervention

Experimental group

Description:

Specific goal-setting, self-monitoring and feed-back

Treatment:

Behavioral: Extended behavioral intervention

Usual care

No Intervention group

Description:

Hospital-based or home-based aerobic exercise 3 times a week with a duration of 30-60 minutes and an intensity of 40-80 % of Vo2max and resistance exercise 2 times a week of 1-3 sets of 10-15 repetitions. The exercise period is 16 weeks.