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Clinical Trials/NCT00176384
NCT00176384
Completed
Phase 2

Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)

University of Leipzig1 site in 1 country36 target enrollmentMarch 2003
ConditionsHeart Failure

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Leipzig
Enrollment
36
Locations
1
Primary Endpoint
Peak oxygen uptake
Status
Completed
Last Updated
18 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
December 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
University of Leipzig

Eligibility 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

Outcomes

Primary Outcomes

Peak oxygen uptake

Secondary Outcomes

  • Skeletal muscle mass
  • Endothelial function
  • Markers of muscle anabolism / catabolism

Study Sites (1)

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