High-intensity Interval Versus Combined Exercise Training in CHF

March 12, 2015 updated by: Serafim Nanas, University of Athens

High-intensity Interval Versus Combined High-intensity Interval and Strength Exercise Training in Chronic Heart Failure

Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major component of rehabilitation / secondary prevention interventions, inducing significant beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity and quality of life, while a positive impact on hospitalization and mortality reduction should not be also excluded. There has been growing interest in the characteristics and modalities of exercise training able to induce optimal benefits. High intensity and interval mode have been shown to induce greater benefits than moderate intensity and continuous mode regimes. Additionally, there has been sound rationale for the inclusion of strength training, which has been also shown able to yield benefits in terms of exercise capacity and quality of life. However, there haven't been much data on the so called combined regimes, which include both aerobic exercise and strength training. This study aims at investigating the effects of combined high-intensity interval and strength training compared to high-intensity interval exercise alone in CHF.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

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

      • Athens, Greece, 10675
        • Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stable heart failure
  • ejection fraction <=45%
  • optimal medical treatment
  • NYHA class <=III

Exclusion Criteria:

  • contraindications for maximal cardiopulmonary exercise testing (CPET)
  • moderate to severe COPD
  • inability to follow exercise programs due to orthopaedic problems

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interval group
high-intensity interval exercise training
High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]
Active Comparator: Combined group
combined exercise training
High intensity [2 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)] and strength exercise training (2-4 sets, 10-12 reps, 60-65% 1RM, for quadriceps and hamstrings, 14 min in total)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
aerobic exercise capacity (assessed by cardiopulmonary exercise testing)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
strength exercise capacity (assessed by 1-repetition maximum test)
Time Frame: 3 months
3 months
quality of life (assessed by MLWHF questionnaire)
Time Frame: 3 months
3 months
quadriceps local adaptations (assessed by muscle biopsies)
Time Frame: 3 months
3 months
quadriceps cross sectional area (assessed by CT)
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Investigators

  • Study Chair: Serafim Nanas, MD, Prof., Cardiopulmonary Exercise Testing & Rehabilitation Laboratory, 1st Critical Care Dpt, School of Medicine, University of Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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

May 1, 2010

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

March 12, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Estimate)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

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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