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

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
exercise training
Adherence measures
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Heart Failure focused on measuring chronic heart failure, exercise training, preferred training, prevention

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marcus DörrRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care

Individualized training

Individualized training plus adherence measures

Arm Description

Usual car accruing to guidelines

Individualized exercise training program in addition to usual care

Individualized exercise training plus measures to increase adherence

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Training adherence
Adherence to training sessions

Full Information

First Posted
January 29, 2014
Last Updated
September 30, 2021
Sponsor
University Medicine Greifswald
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT02051712
Brief Title
Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure
Acronym
HOMEX-HF-P
Official Title
Cardiovascular Effects of Preferred Home-based Exercise Training and Extended Adherence Measures in Systolic Heart Failure - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, exercise training, preferred training, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual car accruing to guidelines
Arm Title
Individualized training
Arm Type
Experimental
Arm Description
Individualized exercise training program in addition to usual care
Arm Title
Individualized training plus adherence measures
Arm Type
Experimental
Arm Description
Individualized exercise training plus measures to increase adherence
Intervention Type
Behavioral
Intervention Name(s)
exercise training
Intervention Description
individualized exercise training
Intervention Type
Behavioral
Intervention Name(s)
Adherence measures
Intervention Description
Measures to increase adherence to exercise training
Primary Outcome Measure Information:
Title
VO2@AT
Description
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)
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Training adherence
Description
Adherence to training sessions
Time Frame
9, 12, 18 and 24 month
Other Pre-specified Outcome Measures:
Title
AE
Description
Adverse events, related and unrelated to exercise training
Time Frame
9, 12, 18 and 24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Dörr, MD
Phone
+49 3834 8680500
Email
mdoerr@uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stepahn B Felix, MD
Phone
+4938348680500
Email
felix@uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Dörr, MD
Organizational Affiliation
University Greifswald
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marcus Dörr
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Dörr, MD
Phone
+49 3834 8680500
Email
mdoerr@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Stephan B Felix, MD
Phone
+4938348680500
Email
felix@uni-greifswald.de

12. IPD Sharing Statement

Learn more about this trial

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

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