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

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Behavioral: exercise training
* Behavioral: Adherence measures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual car accruing to guidelines | |
| Experimental: Individualized training<br>Individualized exercise training program in addition to usual care | Behavioral: exercise training<br>* individualized exercise training<br>|
| Experimental: Individualized training plus adherence measures<br>Individualized exercise training plus measures to increase adherence | Behavioral: exercise training<br>* individualized exercise training<br>Behavioral: Adherence measures<br>* Measures to increase adherence to exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2@AT | 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) | Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training adherence | Adherence to training sessions | 9, 12, 18 and 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic heart failure, exercise training, preferred training, prevention