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Sponsors and Collaborators: |
University of Leipzig German Research Foundation |
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Information provided by: | University of Leipzig |
ClinicalTrials.gov Identifier: | NCT00176319 |
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 |
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Heart Failure Ageing |
Behavioral: Aerobic endurance exercise training (ergometer) |
Phase II |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | May 2005 |
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Group 1: Healthy subjects
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Rainer P Hambrecht, MD | University of Leipzig, Heart Center, Dept. of Cardiology |
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 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
heart failure ageing |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |