Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure

Overview

The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.

Full Title of Study: “Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure – Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Interventions

  • Behavioral: exercise training
    • individualized exercise training
  • Behavioral: Adherence measures
    • Measures to increase adherence to exercise training

Arms, Groups and Cohorts

  • No Intervention: Usual care
    • Usual car accruing to guidelines
  • Experimental: Individualized training
    • Individualized exercise training program in addition to usual care
  • Experimental: Individualized training plus adherence measures
    • Individualized exercise training plus measures to increase adherence

Clinical Trial Outcome Measures

Primary Measures

  • VO2@AT
    • Time Frame: Month 9
    • Change of cardiopulmonary exercise tolerance from baseline to 9 month follow-up measured by exercise testing: oxygen uptake at anaerobic threshold per kg body weight (METs)

Secondary Measures

  • Training adherence
    • Time Frame: 9, 12, 18 and 24 month
    • Adherence to training sessions

Participating in This Clinical Trial

Inclusion Criteria

  • women and men
  • age 30-75 years
  • chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
  • disease duration ≥ 6 month
  • medical therapy accruing to guidelines (drug, devices, including CRT)
  • written informed consent

Exclusion Criteria

  • acute myocarditis
  • instable angina
  • heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
  • severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) < 6 weeks before study start
  • preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
  • uncorrected valve regurgitation or stenosis (> second degree)
  • safety concerns regarding or other reasons against exercise training
  • severe depression
  • regular exercise training within the last 6 weeks
  • life expectancy < 1 year

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Medicine Greifswald
  • Collaborator
    • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marcus Dörr, MD, Principal Investigator, University Greifswald
  • Overall Contact(s)
    • Marcus Dörr, MD, +49 3834 8680500, mdoerr@uni-greifswald.de

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