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

This study has been completed.
Sponsor:
Collaborator:
Deutsche Stiftung für Herzforschung
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176384
First received: September 10, 2005
Last updated: July 31, 2007
Last verified: July 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Leipzig

Additional 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
Study First Received: September 10, 2005
Last Updated: July 31, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013