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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Behavioral: Extended behavioral intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linkoeping, Sweden, 58183
    • Linkoeping University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended behavioral intervention; Specific goal-setting, self-monitoring and feed-back	Behavioral: Extended behavioral intervention; 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.
No Intervention: Usual care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline aerobic exercise capacity (watts) at 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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to dose of exercise	accelerometer	4 months
Adherence to dose in exercise	exercise diary	4 months
Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months	Muscle endurance test	4 months
Change from baseline unilateral isotonic heel lift (repetitions) at 4 months	Muscle endurance test	4 months
Change from baseline anxiety score at 4 months	Hospital Anxiety and Depression Scale (HADS)	4 months
Change from baseline depression score at 4 months	Hospital Anxiety and Depression Scale (HADS)	4 months
Change from baseline self-efficacy score at 4 months	Self Efficacy Exercise Scale (SEE-SV)	4 months
Change from baseline health-related quality of life score at 4 months	Short-Form-36 (SF-36)	4 months
Change from baseline health-related quality of life score at 4 months	EQ5D	4 months
Change from baseline level of physical activity at 4 months	Accelerometer	4 months
Change from baseline level of physical activity at 4 months	Bouchard questionnaire	4 months
Change from baseline aerobic exercise capacity (watts) at 12 months	Submaximal exercise test on bicycle ergometer	12 months
Adherence to dose of exercise	Accelerometer	12 months
Adherence to dose of exercise	Exercise diary	12 months
Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months	Muscle endurance test	12 months
Change from baseline unilateral isotonic heel lift (repetitions) at 12 months	Muscle endurance test	12 months
Change from baseline anxiety score at 12 months	Hospital Anxiety and Depression Scale (HADS)	12 months
Change from baseline depression score at 12 months	Hospital Anxiety and Depression Scale (HADS)	12 months
Change from baseline self-efficacy score at 12 months	Self Efficacy Exercise Scale (SEE-SV)	12 months
Change from baseline health-related quality of life score at 12 months	Short-Form-36 (SF-36)	12 months
Change from baseline health-related quality of life score at 12 months	EQ5D	2 months
Change from baseline level of physical activity at 12 months	accelerometer	12 months
Change from baseline level of physical activity at 12 months	Bouchard questionnaire	12 months
Patient Enablement (score)	Patient Enablement Instrument (PEI)	12 months

Collaborators and Investigators

• Sponsor: Linkoeping University
• Investigators: Study Chair: Maria Bäck, PhD, Linkoeping University, Department of Medical and Health Sciences, Division of Physiotherapy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 15, 2016
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: September 5, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Adherence; Physical capacity; Behavioral medicine; Exercise-based cardiac rehabilitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Dnr: 2015/209-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO