Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure
Impact of Three Months of Aerobic Exercise Training on Exercise Capacity and Peripheral Maladaptations in Patients With Severe Chronic Heart Failure (NYHA III b)
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Mar 2003
Typical duration for phase_2 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedAugust 1, 2007
July 1, 2007
September 10, 2005
July 31, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak oxygen uptake
Secondary Outcomes (3)
Endothelial function
Skeletal muscle mass
Markers of muscle anabolism / catabolism
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- Deutsche Stiftung für Herzforschungcollaborator
Study Sites (1)
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology
Leipzig, Saxony, 04289, Germany
Related Publications (1)
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.
PMID: 20430934DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rainer P Hambrecht, MD
University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
March 1, 2003
Study Completion
December 1, 2006
Last Updated
August 1, 2007
Record last verified: 2007-07