Heart Failure, Diastolic, Ventricular Dysfunction, Left
Conditions
Keywords
exercise therapy
Brief summary
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
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.
Interventions
BEHAVIORALHigh intensity endurance exercise
BEHAVIORALModerate continuous endurance exercise
Sponsors
LHL-Klinikkene, Røros
LHL-Klinikkene, Feiring
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in aerobic capacity measured as oxygen consumption | Baseline and 7 months | Cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP | Baseline to 7 months | — |
| Cardiac function measured as volume, size, efficacy | Baseline to 7 months | Ultrasound |
| Arterial function measured as blood-vessel elasticity | Baseline to 7 months | Ultrasound |
| Feasibility, measured as attrition rate and compliance with exercise | Baseline to 7 months | — |
| Changes in everyday activity level | Baseline to 7 months | Self-reported questionnaire, diary, activity monitoring device |
| Change in diastolic filling pressure measured as E/é | Baseline to 7 months | Ultrasound |
| Quality of life | Baseline to 7 months | Self-reported questionnaires |
Countries
Norway
Outcome results
None listed