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

University Medicine Greifswald1 site in 1 country120 target enrollmentFebruary 2014

ConditionsChronic Heart Failure

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Chronic Heart Failure
Sponsor: University Medicine Greifswald
Enrollment: 120
Locations: 1
Primary Endpoint: VO2@AT
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Medicine Greifswald

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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)