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

December 11, 2023 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Month 9

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE
Time Frame: 9, 12, 18 and 24 month
Adverse events, related and unrelated to exercise training
9, 12, 18 and 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Investigators

  • Principal Investigator: Marcus Dörr, MD, University Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimated)

January 31, 2014

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZHK-HGW-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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