Coronary Artery Disease Clinical Trial
— ECRAOfficial title:
Behavioral Interventions for Improvement of Adherence at Exercise-based Cardiac Rehabilitation (ECRA)
Verified date | October 2021 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | June 2021 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Linkoeping University | Linkoeping |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adherence to dose of exercise | accelerometer | 4 months | |
Secondary | Adherence to dose in exercise | exercise diary | 4 months | |
Secondary | Change from baseline unilateral isotonic shoulder flexion (repetitions) at 4 months | Muscle endurance test | 4 months | |
Secondary | Change from baseline unilateral isotonic heel lift (repetitions) at 4 months | Muscle endurance test | 4 months | |
Secondary | Change from baseline anxiety score at 4 months | Hospital Anxiety and Depression Scale (HADS) | 4 months | |
Secondary | Change from baseline depression score at 4 months | Hospital Anxiety and Depression Scale (HADS) | 4 months | |
Secondary | Change from baseline self-efficacy score at 4 months | Self Efficacy Exercise Scale (SEE-SV) | 4 months | |
Secondary | Change from baseline health-related quality of life score at 4 months | Short-Form-36 (SF-36) | 4 months | |
Secondary | Change from baseline health-related quality of life score at 4 months | EQ5D | 4 months | |
Secondary | Change from baseline level of physical activity at 4 months | Accelerometer | 4 months | |
Secondary | Change from baseline level of physical activity at 4 months | Bouchard questionnaire | 4 months | |
Secondary | Change from baseline aerobic exercise capacity (watts) at 12 months | Submaximal exercise test on bicycle ergometer | 12 months | |
Secondary | Adherence to dose of exercise | Accelerometer | 12 months | |
Secondary | Adherence to dose of exercise | Exercise diary | 12 months | |
Secondary | Change from baseline unilateral isotonic shoulder flexion (repetitions) at 12 months | Muscle endurance test | 12 months | |
Secondary | Change from baseline unilateral isotonic heel lift (repetitions) at 12 months | Muscle endurance test | 12 months | |
Secondary | Change from baseline anxiety score at 12 months | Hospital Anxiety and Depression Scale (HADS) | 12 months | |
Secondary | Change from baseline depression score at 12 months | Hospital Anxiety and Depression Scale (HADS) | 12 months | |
Secondary | Change from baseline self-efficacy score at 12 months | Self Efficacy Exercise Scale (SEE-SV) | 12 months | |
Secondary | Change from baseline health-related quality of life score at 12 months | Short-Form-36 (SF-36) | 12 months | |
Secondary | Change from baseline health-related quality of life score at 12 months | EQ5D | 2 months | |
Secondary | Change from baseline level of physical activity at 12 months | accelerometer | 12 months | |
Secondary | Change from baseline level of physical activity at 12 months | Bouchard questionnaire | 12 months | |
Secondary | Patient Enablement (score) | Patient Enablement Instrument (PEI) | 12 months |
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