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CompletedNCT00176384Updated Aug 1, 2007

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

A Phase 2 interventional study of Aerobic endurance exercise training (ergometer) in Heart Failure, sponsored by University of Leipzig. Completed at 1 site in Germany. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-08-01.

Sponsored by University of Leipzig · Phase 2 and Interventional

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • chronic heart failure
  • exercise training
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 36 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Leipzig is the lead sponsor of 147 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants

Interventions

  • BehavioralAerobic endurance exercise training (ergometer)
06

What researchers measure

Primary outcomes

  1. Peak oxygen uptake

Secondary outcomes

  1. Endothelial function

  2. Skeletal muscle mass

  3. Markers of muscle anabolism / catabolism

07

Study locations

1 site
  • University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
    Leipzig, Saxony 04289, Germany
08

References and documents

Publications

  • Erbs S, Hollriegel R, Linke A, Beck EB, Adams V, Gielen S, Mobius-Winkler S, Sandri M, Krankel N, Hambrecht R, Schuler G. Exercise training in patients with advanced chronic heart failure (NYHA IIIb) promotes restoration of peripheral vasomotor function, induction of endogenous regeneration, and improvement of left ventricular function. Circ Heart Fail. 2010 Jul;3(4):486-94. doi: 10.1161/CIRCHEARTFAILURE.109.868992. Epub 2010 Apr 29. PubMed 20430934 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00176384
Lead sponsor
University of Leipzig
Collaborators
Deutsche Stiftung für Herzforschung
First posted
Sep 15, 2005
Start date
Mar 2003
Completion
Dec 2006
Last update
Aug 1, 2007

Study contacts

Rainer P Hambrecht, MD
principal investigator · University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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