Exercise Training in Patients With Cardioverter-Defibrillators (BETA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00754663
First received: August 4, 2008
Last updated: September 17, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Arrhythmia
Behavioral: exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Reduction of arrhythmia burden, heart rate trend, increase in patients activity. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
exercise training
Behavioral: exercise training
walking training at least 3 times a week
Placebo Comparator: 2
control arm: normal behavior, no additional exercise will be advised
Behavioral: exercise training
walking training at least 3 times a week

Detailed Description:

Detailed anamnesis and a clinical examination will be performed in order to determine the patient's eligibility for the study. The randomisation either to the exercise- or to the control-arm will be performed at baseline. Follow-up visits are planned after four weeks and after three months same for both arms. The close-up visit is planned after 6 months.

The exercise-arm starts off with an introduction into physical training at the Department of Sports Medicine at the University in Tübingen. Ergospirometry and 6-min walk test will be performed to determine the patients' performance. Then the patients will be encouraged to exercise at home. The scales and intensities of physical training will vary interpersonally depending on patients individual performance. Pedometers and the ICD-integrated "Cardiac Compass" function will be used to verify work load, intensity and duration of the physical strain. The patients will be consulted by telephone regularly to affirm the study compliance. The physical activity in the control-arm will be monitored using the ICD-integrated "Cardiac Compass" function.

ICD-programming

  • VT/SVT discrimination "on",
  • "Cardiac Compass" feature "on"
  • VT/VF detection and pacing-programming remain adjusted to clinical situation of the patient

Baseline- and follow-up visits

  • Anamnesis, NYHA-stadium, patients' demographic data: sex, age, weight, hight, concomitant diseases and current medication
  • Clinical examination: weight, inflow-congestion, edema, pulmonary signs of cardiac decompensation
  • Chest- x-ray (baseline, 6 moths FU)
  • 6-min walk test (baseline, 6 moths FU)
  • Blood take (baseline, 6 moths FU) standard examinations including blood morphology, troponin, renal retention parameters, transaminases)
  • Determination of the BNP plasma level
  • Echocardiography (baseline, 6 moths FU): left-ventricular function (EF) and diameter, valvular function, estimating of systolic pulmonary arterial pressure (PAP sys.).
  • Ergospirometry (baseline, 6 moths FU):peak-oxygen-uptake-volume, starting at 10 Watt with increase of the work load 12 Watts per minute until the work load capacity has been reached. The achieved VO2 value is defined as the 100 % oxygen-uptake. At home the patients are supposed to exercise at about 70 % of their VO2 peak.
  • Measurement/Recording of the peripheral oxygen-uptake of the muscle with near-infrared-spectroscopy simultaneously with the bicycle-ergometric exposure.
  • Complete interrogation of the ICD-memory, acquisition of the "Cardiac-Compass"-data, sensing- and threshold-test, recording of electrical impedance and checking of the battery-status, impedance and checking of the battery-status
  • Acquisition of the standardized questionnaires concerning quality-of-life, personality, depression and anxiety: PHQ-D, DS14, FSGV 1.0 and GAD-7.

Definition of adverse event

  • Adverse event (AE): Any decrease of existential orientation, unwanted incidence, subjective or objective symptom of any kind of disease, impairment or any accident, that may or may not be connected to the study is defined as an (AE).
  • Severe adverse event (SAE): A SAE is an event which is life-threatening or deadly, causes significant or chronic damage, requires hospitalization or threatens the patient's physical inviolability in any other way.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754663

Contacts
Contact: Slawomir Weretka, MD +49 7071 29 83196 weretka@hotmail.com
Contact: Jurgen Schreieck, MD +49 7071 2982711 ext 8781 juergen.schreieck@med.uni-tuebingen.de

Locations
Germany
University Clinic, Dept. of Cardiology Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Slawomir Weretka, MD    +49 7071 29 83196    weretka@hotmail.com   
Contact: Jürgen Schreieck, MD    +49 7071 29 82711 ext 8781    juergen.schreieck@med.uni-tuebingen.de   
Principal Investigator: Slawomir Weretka, MD         
Sub-Investigator: Juergen Schreieck, MD         
Sub-Investigator: Jochen Hansel, MD         
Sub-Investigator: Konstantinos Stellos, MD         
Sub-Investigator: Martin Teufel, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Slawomir Weretka, MD University Hospital Tuebingen
Study Chair: Juergen Schreieck, MD University Hospital Tuebingen
  More Information

Additional Information:
Publications:
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. Epub 2005 Sep 13. No abstract available.

Responsible Party: Dr. med. Slawomir Weretka, University Hospital Tübingen, Germany
ClinicalTrials.gov Identifier: NCT00754663     History of Changes
Other Study ID Numbers: 01
Study First Received: August 4, 2008
Last Updated: September 17, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
exercise
implantable cardioverter-defibrillator
arrhythmia

ClinicalTrials.gov processed this record on September 22, 2014