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Coronary Artery DiseaseECRANCT02895451

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

A study testing Extended behavioral intervention in people with Coronary Artery Disease, run by Linkoeping University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Extended behavioral intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
1 siteSweden
Study dates
15 Dec 2016to Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Linkoeping University

    Linköping, 58183

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Extended behavioral intervention
Keywords
Exercise-based cardiac rehabilitation, Physical capacity, Adherence, Behavioral medicine
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended behavioral interventionBehavioural

    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.

Study groups in NCT02895451
Study groupRoleWhat they receive
Extended behavioral interventionExperimentalSpecific goal-setting, self-monitoring and feed-back
Receives: Behavioral: Extended behavioral intervention
Usual careNo interventionHospital-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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 months

Secondary outcomes (24)

  1. Adherence to dose of exercise

    accelerometer

    Measured: 4 months

  2. Adherence to dose in exercise

    exercise diary

    Measured: 4 months

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

    Muscle endurance test

    Measured: 4 months

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

    Muscle endurance test

    Measured: 4 months

  5. Change from baseline anxiety score at 4 months

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 4 months

  6. Change from baseline depression score at 4 months

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 4 months

  7. Change from baseline self-efficacy score at 4 months

    Self Efficacy Exercise Scale (SEE-SV)

    Measured: 4 months

  8. Change from baseline health-related quality of life score at 4 months

    Short-Form-36 (SF-36)

    Measured: 4 months

  9. Change from baseline health-related quality of life score at 4 months

    EQ5D

    Measured: 4 months

  10. Change from baseline level of physical activity at 4 months

    Accelerometer

    Measured: 4 months

  11. Change from baseline level of physical activity at 4 months

    Bouchard questionnaire

    Measured: 4 months

  12. Change from baseline aerobic exercise capacity (watts) at 12 months

    Submaximal exercise test on bicycle ergometer

    Measured: 12 months

  13. Adherence to dose of exercise

    Accelerometer

    Measured: 12 months

  14. Adherence to dose of exercise

    Exercise diary

    Measured: 12 months

  15. Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months

    Muscle endurance test

    Measured: 12 months

  16. Change from baseline unilateral isotonic heel lift (repetitions) at 12 months

    Muscle endurance test

    Measured: 12 months

  17. Change from baseline anxiety score at 12 months

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 12 months

  18. Change from baseline depression score at 12 months

    Hospital Anxiety and Depression Scale (HADS)

    Measured: 12 months

  19. Change from baseline self-efficacy score at 12 months

    Self Efficacy Exercise Scale (SEE-SV)

    Measured: 12 months

  20. Change from baseline health-related quality of life score at 12 months

    Short-Form-36 (SF-36)

    Measured: 12 months

  21. Change from baseline health-related quality of life score at 12 months

    EQ5D

    Measured: 2 months

  22. Change from baseline level of physical activity at 12 months

    accelerometer

    Measured: 12 months

  23. Change from baseline level of physical activity at 12 months

    Bouchard questionnaire

    Measured: 12 months

  24. Patient Enablement (score)

    Patient Enablement Instrument (PEI)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2016 (estimated)
  2. Study start15 Dec 2016
  3. Primary completion15 Apr 2019
  4. Study completionJun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02895451
Sponsor's protocol ID
Dnr: 2015/209-31
Acronym
ECRA
Status last verified
Oct 2021
First submitted
16 Aug 2016
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36964593

  • 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.

    PubMed 32419950

  • 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.

    PubMed 28545400

Questions about this trial

What is this clinical trial studying?

A study testing Extended behavioral intervention in people with Coronary Artery Disease, run by Linkoeping University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline aerobic exercise capacity (watts) at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02895451, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.

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