Exercise Training in Treating Diastolic Heart Failure

Not Applicable

Withdrawn

• Conditions: Heart Failure, Diastolic; Ventricular Dysfunction, Left
• Interventions: Behavioral: High intensity endurance exercise; Behavioral: Moderate continuous endurance exercise

• Registration Number: NCT02155842
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study First Submitted: 2014-05-27
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity endurance exercise	High intensity endurance exercise	Four weeks comprehensive cardiac rehabilitation with moderate volume high intensity endurance exercise, followed by 6 months non-supervised endurance exercise
Moderate continuous endurance exercise	Moderate continuous endurance exercise	Four weeks comprehensive cardiac rehabilitation with moderate volume moderate intensity endurance exercise, followed by 6 months non-supervised endurance exercise

Primary Outcome Measures

Name	Time	Method
Change in aerobic capacity measured as oxygen consumption	Baseline and 7 months	Cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Arterial function measured as blood-vessel elasticity	Baseline to 7 months	Ultrasound
Cardiac function measured as volume, size, efficacy	Baseline to 7 months	Ultrasound
Quality of life	Baseline to 7 months	Self-reported questionnaires
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
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

Trial Locations

Locations (1)

LHL Klinikkene; 🇳🇴 Røros, Norway