Age-Related Effects of Exercise Training on Skeletal Muscle Metabolism in Health and Heart Failure - Full Text View

Sponsors and Collaborators:	University of Leipzig German Research Foundation
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00176319

Purpose

In both ageing and heart failure progressing exercise intolerance is observed. The hypothesis of the clinical trial is that inflammatory activation in the skeletal muscle with subsequent protein catabolism is a common pathway to both conditions.

Aim of the trial is therefore to compare the effects of aerobic exercise training on muscle inflammation and catabolism in young and old healthy subjects as well as in young and old heart failure patients.

Condition	Intervention	Phase
Heart Failure Ageing	Behavioral: Aerobic endurance exercise training (ergometer)	Phase II

MedlinePlus related topics: Exercise and Physical Fitness Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Interaction Between Myocardial Function and the Peripheral Skeletal Muscle in Ageing and Heart Failure - Importance of Inflammatory/Catabolic Factors and Effects of Physical Activity

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

Expression of proinflammatory cytokines
Markers of anabolism/catabolism

Secondary Outcome Measures:

VO2 max
Endothelial function
Change in muscle mass

Estimated Enrollment:	120
Study Start Date:	May 2005

Detailed Description:

A total of 60 healthy subjects and 60 heart failure patients (in each group 30 <55 years, 30 >65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or control group.

Before and after the intervention period maximal exercise tolerance is determined by ergospirometry, endothelial function is measured by high-resolution A-mode ultrasound, and thigh muscle mass is assessed by CT. Skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of catabolism/anabolism.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Group 1: Healthy subjects

normal left ventricular ejection fraction (EF) >55%
normal coronary artery disease (cardiac catheterization) Group 2: CHF patients
reduced left ventricular ejection fraction (EF) <40%
stable clinical condition (NYHA II-III)

Exclusion Criteria:

COLD
cardiac decompensation <3 months
ventricular arrhythmias >Lown IVb
myocardial infarction < 4 weeks
valvular heart disease >II°
insulin-dependent diabetes mellitus
arterial hypertension
orthopedic conditions prohibiting training participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176319

Contacts

Contact: Rainer P Hambrecht, MD	-49-341-865 ext 1428	hamr@medizin.uni-leipzig.de
Contact: Stephan Gielen, MD	-49-341-865 ext 1428	stephan.gielen@medizin.uni-leipzig.de

Locations

Germany, Saxony
Universität Leipzig, Herzzentrum, Klinik für Innere Medizin/Kardiologie	Recruiting
Leipzig, Saxony, Germany, 04289
Contact: Rainer P Hambrecht, MD +49-341-865 ext 1428 hamr@medizin.uni-leipzig.de
Contact: Stephan Gielen, MD +49-341-865 ext 1428 stephan.gielen@medizin.uni-leipzig.de
Sub-Investigator: Stephan Gielen, MD

Sponsors and Collaborators

University of Leipzig

German Research Foundation

Investigators

Principal Investigator:

Rainer P Hambrecht, MD

University of Leipzig, Heart Center, Dept. of Cardiology

More Information

Study ID Numbers:	GI 535/1-1, GI 535/1-1
Study First Received:	September 9, 2005
Last Updated:	April 25, 2006
ClinicalTrials.gov Identifier:	NCT00176319
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:

heart failure
ageing

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009