Clinical trial NCT02895451: Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Official title: Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Exercise-based cardiac rehabilitation
Physical capacity
Adherence
Behavioral medicine
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2016-09-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline aerobic exercise capacity (watts) at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Adherence to dose of exercise
timeFrame: 4 months
measure: Adherence to dose in exercise
timeFrame: 4 months
measure: Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months
timeFrame: 4 months
measure: Change from baseline unilateral isotonic heel lift (repetitions) at 4 months
timeFrame: 4 months
measure: Change from baseline anxiety score at 4 months
timeFrame: 4 months
measure: Change from baseline depression score at 4 months
timeFrame: 4 months
measure: Change from baseline self-efficacy score at 4 months
timeFrame: 4 months
measure: Change from baseline health-related quality of life score at 4 months
timeFrame: 4 months
measure: Change from baseline health-related quality of life score at 4 months
timeFrame: 4 months
measure: Change from baseline level of physical activity at 4 months
timeFrame: 4 months
measure: Change from baseline level of physical activity at 4 months
timeFrame: 4 months
measure: Change from baseline aerobic exercise capacity (watts) at 12 months
timeFrame: 12 months
measure: Adherence to dose of exercise
timeFrame: 12 months
measure: Adherence to dose of exercise
timeFrame: 12 months
measure: Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months
timeFrame: 12 months
measure: Change from baseline unilateral isotonic heel lift (repetitions) at 12 months
timeFrame: 12 months
measure: Change from baseline anxiety score at 12 months
timeFrame: 12 months
measure: Change from baseline depression score at 12 months
timeFrame: 12 months
measure: Change from baseline self-efficacy score at 12 months
timeFrame: 12 months
measure: Change from baseline health-related quality of life score at 12 months
timeFrame: 12 months
measure: Change from baseline health-related quality of life score at 12 months
timeFrame: 2 months
measure: Change from baseline level of physical activity at 12 months
timeFrame: 12 months
measure: Change from baseline level of physical activity at 12 months
timeFrame: 12 months
measure: Patient Enablement (score)
timeFrame: 12 months
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: Linkoeping University
Study officials:
affiliation: Linkoeping University, Department of Medical and Health Sciences, Division of Physiotherapy
name: Maria Bäck, PhD
role: STUDY_CHAIR
References:
citation: Freene N, Borg S, McManus M, Mair T, Tan R, Davey R, Oberg B, Back M. Comparison of device-based physical activity and sedentary behaviour following percutaneous coronary intervention in a cohort from Sweden and Australia: a harmonised, exploratory study. BMC Sports Sci Med Rehabil. 2020 May 9;12:17. doi: 10.1186/s13102-020-00164-1. eCollection 2020.
citation: Borg S, Oberg B, Nilsson L, Soderlund A, Back M. 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. BMC Cardiovasc Disord. 2017 May 25;17(1):134. doi: 10.1186/s12872-017-0557-7.