Clinical trial NCT00176384: Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: chronic heart failure
exercise training
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2005-09-15
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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.

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

Primary outcomes:
measure: Peak oxygen uptake
Secondary outcomes:
measure: Endothelial function
measure: Skeletal muscle mass
measure: Markers of muscle anabolism / catabolism
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
state: Saxony
Study officials:
affiliation: University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
name: Rainer P Hambrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.