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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Aerobic endurance exercise training (ergometer)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Rainer P Hambrecht, MD

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology, Leipzig, Germany

Locations

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University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 20430934 (View on PubMed)

Other Identifiers

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F21/02

Identifier Type: -

Identifier Source: org_study_id