Exercise Training in Patients With Cardioverter-Defibrillators

NCT00754663 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available. This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.

Conditions

Arrhythmia

Keywords

exercise; implantable cardioverter-defibrillator; arrhythmia

Outcome Measures

Primary Outcomes (1)

• Reduction of arrhythmia burden, heart rate trend, increase in patients activity.

  6 months

Secondary Outcomes (1)

• Ineffective ICD-interventions, injury risk due to syncope, hospitalization, death. LVEF (echocardiography), VO2max, anaerobic threshold (AT), respiratory compensation point (RCP) and equivalents for O2 and CO2 (ergospirometry) BNP plasma level

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

exercise training

Behavioral: exercise training

2

PLACEBO COMPARATOR

control arm: normal behavior, no additional exercise will be advised

Behavioral: exercise training

Interventions

exercise training BEHAVIORAL

walking training at least 3 times a week

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both gender at a minimum age of 18 years
• ICD-systems with "Cardiac-Compass" (Medtronic)-diagnostic feature
• ICD system implanted for at least three months
• congestive heart failure, NYHA II and III
• LVEF ≤ 40 %
• compensated state, optimized and stable pharmacological therapy at least for the last three months
• load capacity of at least 50 watt at baseline.

You may not qualify if:

• unable or unwilling to give informed consent
• acute coronary syndrome during the past thirty days
• hemodynamically relevant valvular defect
• instable arterial hypertension
• severe COPD
• reduced work load capacity caused by instable angina pectoris, peripheral vascular, neurological or orthopaedic concomitant disease
• hypertrophic obstructive cardiomyopathy (HOCM)
• pulmonary-arterial hypertension (PAP systolic ≥ 60 mmHg).

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Clinic, Dept. of Cardiology

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Related Publications (12)

• Lakka TA, Venalainen JM, Rauramaa R, Salonen R, Tuomilehto J, Salonen JT. Relation of leisure-time physical activity and cardiorespiratory fitness to the risk of acute myocardial infarction. N Engl J Med. 1994 Jun 2;330(22):1549-54. doi: 10.1056/NEJM199406023302201.

  PMID: 8177243 BACKGROUND

• Schuler G. [Physical activity]. Z Kardiol. 2005;94 Suppl 3:III/11-4. doi: 10.1007/s00392-005-1303-1. German.

  PMID: 16258787 BACKGROUND

• Dursch M, Schulz O. [Restructuring cardiovascular exercise therapy in Germany with reference to current international guidelines]. Herz. 2003 Aug;28(5):349-58. doi: 10.1007/s00059-003-2438-3. German.

  PMID: 12928734 BACKGROUND

• Schulz O, Dursch M. [From bench to bicycle. Risk assessment in connection with sports activities and exercise programs in the primary and secondary prevention of cardiovascular diseases]. Herz. 2003 Aug;28(5):359-73. doi: 10.1007/s00059-003-2463-9. German.

  PMID: 12928735 BACKGROUND

• Erbs S, Linke A, Gielen S, Fiehn E, Walther C, Yu J, Adams V, Schuler G, Hambrecht R. Exercise training in patients with severe chronic heart failure: impact on left ventricular performance and cardiac size. A retrospective analysis of the Leipzig Heart Failure Training Trial. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):336-44. doi: 10.1097/01.hjr.0000099031.38268.27.

  PMID: 14663295 BACKGROUND

• Hambrecht R, Gielen S, Linke A, Fiehn E, Yu J, Walther C, Schoene N, Schuler G. Effects of exercise training on left ventricular function and peripheral resistance in patients with chronic heart failure: A randomized trial. JAMA. 2000 Jun 21;283(23):3095-101. doi: 10.1001/jama.283.23.3095.

  PMID: 10865304 BACKGROUND

• Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82. doi: 10.1161/01.cir.99.9.1173.

  PMID: 10069785 BACKGROUND

• Kamke W, Dovifat C, Schranz M, Behrens S, Moesenthin J, Voller H. Cardiac rehabilitation in patients with implantable defibrillators. Feasibility and complications. Z Kardiol. 2003 Oct;92(10):869-75. doi: 10.1007/s00392-003-0997-1.

  PMID: 14579052 BACKGROUND

• Vanhees L, Schepers D, Heidbuchel H, Defoor J, Fagard R. Exercise performance and training in patients with implantable cardioverter-defibrillators and coronary heart disease. Am J Cardiol. 2001 Mar 15;87(6):712-5. doi: 10.1016/s0002-9149(00)01488-0.

  PMID: 11249888 BACKGROUND

• Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbuchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. doi: 10.1016/j.ehj.2004.04.034.

  PMID: 15231370 BACKGROUND

• Lampert R, Cannom D, Olshansky B. Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members. J Cardiovasc Electrophysiol. 2006 Jan;17(1):11-5. doi: 10.1111/j.1540-8167.2005.00331.x.

  PMID: 16426392 BACKGROUND

• Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.

  PMID: 16160202 BACKGROUND

Related Links

• Study projects/ Dept. of Cardiology Electrophysiology, Univ. Clinic Tübingen

MeSH Terms

Conditions

Arrhythmias, Cardiac; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Slawomir Weretka, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

• Juergen Schreieck, MD

  University Hospital Tuebingen

  STUDY CHAIR

Central Study Contacts

Slawomir Weretka, MD

CONTACT

+49 7071 29 83196; weretka@hotmail.com

Jurgen Schreieck, MD

CONTACT

+49 7071 2982711; juergen.schreieck@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: September 18, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 18, 2008

Record last verified: 2008-09

Locations

DE (1)