Exercise Training in Treating Diastolic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High Versus Moderate Intensity Endurance Exercise Training in Treating Diastolic Heart Failure

Conditions
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Heart Failure, Diastolic, Ventricular Dysfunction, Left

Intervention / Treatment
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* Behavioral: High intensity endurance exercise
* Behavioral: Moderate continuous endurance exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary lifestyle Normal systolic function left ventricular ejection fraction (LVEF) < 50% New York Heart Association (NYHA) class II or III Diastolic dysfunction (E/é < 15 or E/é 8-15 and N-terminal proBNP > 220pg/ml) Medically stable the last 4 weeks Written informed consent Exclusion Criteria: Other causes of dyspnea than diastolic heart failure Personal preferences or characteristics prohibiting the person from attending inpatient cardiac rehabilitation Not able to perform physical exercise

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity endurance exercise<br>Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise | Behavioral: High intensity endurance exercise<br> <br> |
| Active Comparator: Moderate continuous endurance exercise<br>Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise | Behavioral: Moderate continuous endurance exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aerobic capacity measured as oxygen consumption | Cardiopulmonary exercise test | Baseline and 7 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise therapy