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

NCT02895451 | Completed DMC

• 1 other identifier: Dnr: 2015/209-31
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Exercise-based cardiac rehabilitation; Physical capacity; Adherence; Behavioral medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Adherence to dose of exercise

  4 months

• Adherence to dose in exercise

  4 months

• Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months

  4 months

• Change from baseline unilateral isotonic heel lift (repetitions) at 4 months

  4 months

• Change from baseline anxiety score at 4 months

  4 months

Study Arms (2)

Extended behavioral intervention

EXPERIMENTAL

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

Behavioral: Extended behavioral intervention

Usual care

NO INTERVENTION

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.

Interventions

Extended behavioral intervention BEHAVIORAL

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.

Extended behavioral intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Linkoeping University

Linköping, 58183, Sweden

Location

Related Publications (3)

• Borg S, Oberg B, Nilsson L, Alfredsson J, Soderlund A, Back M. Effectiveness of a behavioral medicine intervention in physical therapy on secondary psychological outcomes and health-related quality of life in exercise-based cardiac rehabilitation: a randomized, controlled trial. BMC Sports Sci Med Rehabil. 2023 Mar 24;15(1):42. doi: 10.1186/s13102-023-00647-x.

  PMID: 36964593 DERIVED

• 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.

  PMID: 32419950 DERIVED

• 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.

  PMID: 28545400 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Maria Bäck, PhD

  Linkoeping University, Department of Medical and Health Sciences, Division of Physiotherapy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RPT

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: September 9, 2016
• Study Start: December 15, 2016
• Primary Completion: April 15, 2019
• Study Completion: June 1, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)