HOMEX-HF-P: Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure

Sponsor

University Medicine Greifswald (Other)

Overall Status

Recruiting

CT.gov ID

NCT02051712

Collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other)

120

Enrollment

Location

Arms

106

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure	Behavioral: exercise training Behavioral: Adherence measures	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care Usual car accruing to guidelines
Experimental: Individualized training Individualized exercise training program in addition to usual care	Behavioral: exercise training individualized exercise training
Experimental: Individualized training plus adherence measures Individualized exercise training plus measures to increase adherence	Behavioral: exercise training individualized exercise training Behavioral: Adherence measures Measures to increase adherence to exercise training

Arm

Intervention/Treatment

No Intervention: Usual care

Usual car accruing to guidelines

Experimental: Individualized training

Individualized exercise training program in addition to usual care

Behavioral: exercise training

individualized exercise training

Experimental: Individualized training plus adherence measures

Individualized exercise training plus measures to increase adherence

Behavioral: exercise training

individualized exercise training

Behavioral: Adherence measures

Measures to increase adherence to exercise training

Outcome Measures

Primary Outcome Measures

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

Training adherence [9, 12, 18 and 24 month]
Adherence to training sessions

Other Outcome Measures

AE [9, 12, 18 and 24 month]
Adverse events, related and unrelated to exercise training

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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