deltatrials
Unknown NA INTERVENTIONAL 2-arm NCT00754663

Exercise Training in Patients With Cardioverter-Defibrillators (BETA)

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

Sponsor: University Hospital Tuebingen

Conditions Arrhythmia
Interventions exercise training
Updated 6 times since 2017 Last updated: Sep 17, 2008 Started: May 31, 2008 Primary completion: Sep 30, 2009 Completion: Nov 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Arrhythmia, this trial is ongoing. The trial is conducted by University Hospital Tuebingen and has accumulated 6 data snapshots since 2008. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Study Description(click to expand)

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,...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotUnknown Status~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Present [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Jan 2021 — Jul 2024 [monthly]

    Unknown Status NA

  5. Jun 2018 — Jan 2021 [monthly]

    Unknown Status NA

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Unknown Status NA

    First recorded

May 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University Hospital Tuebingen
Data source: University Hospital Tuebingen

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations