Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02895451
Recruitment Status : Active, not recruiting
First Posted : September 9, 2016
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Bäck, Linkoeping University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Extended behavioral intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Study Start Date : December 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change from baseline aerobic exercise capacity (watts) at 4 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Adherence to dose of exercise [ Time Frame: 4 months ]
    accelerometer

  2. Adherence to dose in exercise [ Time Frame: 4 months ]
    exercise diary

  3. Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months [ Time Frame: 4 months ]
    Muscle endurance test

  4. Change from baseline unilateral isotonic heel lift (repetitions) at 4 months [ Time Frame: 4 months ]
    Muscle endurance test

  5. Change from baseline anxiety score at 4 months [ Time Frame: 4 months ]
    Hospital Anxiety and Depression Scale (HADS)

  6. Change from baseline depression score at 4 months [ Time Frame: 4 months ]
    Hospital Anxiety and Depression Scale (HADS)

  7. Change from baseline self-efficacy score at 4 months [ Time Frame: 4 months ]
    Self Efficacy Exercise Scale (SEE-SV)

  8. Change from baseline health-related quality of life score at 4 months [ Time Frame: 4 months ]
    Short-Form-36 (SF-36)

  9. Change from baseline health-related quality of life score at 4 months [ Time Frame: 4 months ]
    EQ5D

  10. Change from baseline level of physical activity at 4 months [ Time Frame: 4 months ]
    Accelerometer

  11. Change from baseline level of physical activity at 4 months [ Time Frame: 4 months ]
    Bouchard questionnaire

  12. Change from baseline aerobic exercise capacity (watts) at 12 months [ Time Frame: 12 months ]
    Submaximal exercise test on bicycle ergometer

  13. Adherence to dose of exercise [ Time Frame: 12 months ]
    Accelerometer

  14. Adherence to dose of exercise [ Time Frame: 12 months ]
    Exercise diary

  15. Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months [ Time Frame: 12 months ]
    Muscle endurance test

  16. Change from baseline unilateral isotonic heel lift (repetitions) at 12 months [ Time Frame: 12 months ]
    Muscle endurance test

  17. Change from baseline anxiety score at 12 months [ Time Frame: 12 months ]
    Hospital Anxiety and Depression Scale (HADS)

  18. Change from baseline depression score at 12 months [ Time Frame: 12 months ]
    Hospital Anxiety and Depression Scale (HADS)

  19. Change from baseline self-efficacy score at 12 months [ Time Frame: 12 months ]
    Self Efficacy Exercise Scale (SEE-SV)

  20. Change from baseline health-related quality of life score at 12 months [ Time Frame: 12 months ]
    Short-Form-36 (SF-36)

  21. Change from baseline health-related quality of life score at 12 months [ Time Frame: 2 months ]
    EQ5D

  22. Change from baseline level of physical activity at 12 months [ Time Frame: 12 months ]
    accelerometer

  23. Change from baseline level of physical activity at 12 months [ Time Frame: 12 months ]
    Bouchard questionnaire

  24. Patient Enablement (score) [ Time Frame: 12 months ]
    Patient Enablement Instrument (PEI)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895451


Locations
Layout table for location information
Sweden
Linkoeping University
Linkoeping, Sweden, 58183
Sponsors and Collaborators
Linkoeping University
Investigators
Layout table for investigator information
Study Chair: Maria Bäck, PhD Linkoeping University, Department of Medical and Health Sciences, Division of Physiotherapy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maria Bäck, PhD, RPT, Linkoeping University
ClinicalTrials.gov Identifier: NCT02895451    
Other Study ID Numbers: Dnr: 2015/209-31
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maria Bäck, Linkoeping University:
Exercise-based cardiac rehabilitation
Physical capacity
Adherence
Behavioral medicine
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases