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

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ClinicalTrials.gov Identifier: NCT00176384
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 1, 2007
Sponsor:
Collaborator:
Deutsche Stiftung für Herzforschung
Information provided by:
University of Leipzig

Brief Summary:

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 or disease Intervention/treatment Phase
Heart Failure Behavioral: Aerobic endurance exercise training (ergometer) Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
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)
Study Start Date : March 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Peak oxygen uptake

Secondary Outcome Measures :
  1. Endothelial function
  2. Skeletal muscle mass
  3. Markers of muscle anabolism / catabolism


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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

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

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 Posted: September 15, 2005    Key Record Dates
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