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Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176384
First Posted: September 15, 2005
Last Update Posted: August 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Deutsche Stiftung für Herzforschung
Information provided by:
University of Leipzig
  Purpose

Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure.

Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.


Condition Intervention Phase
Heart Failure Behavioral: Aerobic endurance exercise training (ergometer) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Peak oxygen uptake

Secondary Outcome Measures:
  • Endothelial function
  • Skeletal muscle mass
  • Markers of muscle anabolism / catabolism

Estimated Enrollment: 36
Study Start Date: March 2003
Study Completion Date: December 2006
Detailed Description:

A total of 36 patients with severe chronic heart failure are prospectively randomized to either 3 months of aerobic ergometer training or a sedentary control group.

Before and after the intervention period maximal exercise capacity is assessed by ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3 months and are analyzed for markers of muscle catabolism/anabolism.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic heart failure (NYHA class III b)
  • peak oxygen uptake <20 mL/min/kg body weight
  • left ventricular ejection fraction <25 %
  • left ventricular end-diastolic diameter >60 mm

Exclusion Criteria:

  • exercise-induced myocardial ischemia
  • cardiac decompensation within the last 8 weeks
  • ventricular arrhythmias (>Lown 4b) in patients not protected by an ICD
  • insulin-dependent diabetes mellitus
  • uncontrolled arterial hypertension
  • orthopedic conditions excluding training participation
  • body mass index >30 kg/m2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00176384


Locations
Germany
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Deutsche Stiftung für Herzforschung
Investigators
Principal Investigator: Rainer P Hambrecht, MD University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00176384     History of Changes
Other Study ID Numbers: F21/02
First Submitted: September 10, 2005
First Posted: September 15, 2005
Last Update Posted: August 1, 2007
Last Verified: July 2007

Keywords provided by University of Leipzig:
chronic heart failure
exercise training

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases