Exercise Training in Patients With Cardioverter-Defibrillators (BETA)

September 17, 2008 updated by: University Hospital Tuebingen

BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Recruiting
        • University Clinic, Dept. of Cardiology
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of arrhythmia burden, heart rate trend, increase in patients activity.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Slawomir Weretka, MD, University Hospital Tuebingen
  • Study Chair: Juergen Schreieck, MD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2008

Last Update Submitted That Met QC Criteria

September 17, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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