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Unforseen problems recruiting patients
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| Name | Class |
|---|---|
| LHL-Klinikkene, Røros | OTHER |
| LHL-Klinikkene, Feiring | OTHER |
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The purpose of this study is to determine whether endurance exercise of either high or moderate intensity can reverse structural and functional changes of the heart in patients with diastolic heart failure, and to investigate which type of exercise is best in terms of aerobe capacity and quality of life.
The investigators expect that high intensity endurance exercise is superior to moderate intensity endurance exercise.
This study is a prospective randomized controlled intervention study comparing two active arms. Eligible patients are being sampled consecutively by cardiologists, and randomized to either high or moderate intensity endurance exercise. Endpoints are measured at baseline, 4 weeks and 7 months. The intervention is considered safe, and the study has been approved by the Regional Ethics Committee (REK-midt).
This project has been financially supported by the Norwegian ExtraFoundation for Health and Rehabilitation through EXTRA funds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity endurance exercise | Experimental | Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise |
|
| Moderate continuous endurance exercise | Active Comparator | Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity endurance exercise | Behavioral |
| ||
| Moderate continuous endurance exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aerobic capacity measured as oxygen consumption | Cardiopulmonary exercise test | Baseline and 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, measured as attrition rate and compliance with exercise | Baseline to 7 months | |
| Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP | Baseline to 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrik Wisløff, phd prof | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LHL Klinikkene | Røros | Norway |
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| ID | Term |
|---|---|
| D054144 | Heart Failure, Diastolic |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| Behavioral |
|
| Cardiac function measured as volume, size, efficacy | Ultrasound | Baseline to 7 months |
| Arterial function measured as blood-vessel elasticity | Ultrasound | Baseline to 7 months |
| Quality of life | Self-reported questionnaires | Baseline to 7 months |
| Changes in everyday activity level | Self-reported questionnaire, diary, activity monitoring device | Baseline to 7 months |
| Change in diastolic filling pressure measured as E/é | Ultrasound | Baseline to 7 months |