Home-based exercise training for patients with heart failure
Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
This study tests if a personalized home exercise program can help people with chronic heart failure get better at exercising compared to regular care, and if extra tools can help them stick to the program.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | University Medicine Greifswald Academic / other |
| Locations | 1 site (Greifswald) |
| Trial ID | NCT02051712 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an individualized home-based exercise training program compared to usual care in improving exercise tolerance in patients with chronic heart failure. It will also assess whether additional tools designed to enhance exercise adherence can further improve outcomes. Furthermore, the study seeks to identify biomarkers that could be used in future interventions to promote exercise adherence among these patients.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 30-75 with chronic heart failure (NYHA II/III) and a left ventricular ejection fraction of 40% or less.
Not a fit: Patients with severe cardiovascular conditions, recent heart surgeries, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise tolerance and quality of life for patients with chronic heart failure.
How similar studies have performed: Other studies have shown promising results with similar exercise interventions in chronic heart failure, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Greifswald
- Marcus Dörr — Greifswald, Germany (Recruiting)
Study contacts
- Principal investigator: Marcus Dörr, MD — University Greifswald
- Study coordinator: Marcus Dörr, MD
- Email: mdoerr@uni-greifswald.de
- Phone: +49 3834 8680500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.