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

Phase 3

Recruiting

• Conditions: Chronic Heart Failure
• Interventions: Behavioral: exercise training; Behavioral: Adherence measures

• Registration Number: NCT02051712
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized training plus adherence measures	exercise training	Individualized exercise training plus measures to increase adherence
Individualized training plus adherence measures	Adherence measures	Individualized exercise training plus measures to increase adherence
Individualized training	exercise training	Individualized exercise training program in addition to usual care

Primary Outcome Measures

Name	Time	Method
VO2@AT	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 Outcome Measures

Name	Time	Method
Training adherence	9, 12, 18 and 24 month	Adherence to training sessions

Trial Locations

Locations (1)

Marcus Dörr; 🇩🇪 Greifswald, Germany