Exercise Training in Treating Diastolic Heart Failure (TREND-HF)

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

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.

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Røros, Norway
        • LHL Klinikkene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in aerobic capacity measured as oxygen consumption
Time Frame: Baseline and 7 months
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
Time Frame: Baseline to 7 months
Baseline to 7 months
Blood-risk profile, measured as changes in cholesterol, hemoglobin, N terminal-proBNP
Time Frame: Baseline to 7 months
Baseline to 7 months
Cardiac function measured as volume, size, efficacy
Time Frame: Baseline to 7 months
Ultrasound
Baseline to 7 months
Arterial function measured as blood-vessel elasticity
Time Frame: Baseline to 7 months
Ultrasound
Baseline to 7 months
Quality of life
Time Frame: Baseline to 7 months
Self-reported questionnaires
Baseline to 7 months
Changes in everyday activity level
Time Frame: Baseline to 7 months
Self-reported questionnaire, diary, activity monitoring device
Baseline to 7 months
Change in diastolic filling pressure measured as E/é
Time Frame: Baseline to 7 months
Ultrasound
Baseline to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 2, 2014

First Posted (Estimate)

June 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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