NCT02051712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

10.4 years

First QC Date

January 29, 2014

Last Update Submit

December 11, 2023

Conditions

Chronic Heart Failure

Keywords

chronic heart failureexercise trainingpreferred trainingprevention

Outcome Measures

Primary Outcomes (1)

  • 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)

    Month 9

Secondary Outcomes (1)

  • Training adherence

    9, 12, 18 and 24 month

Other Outcomes (1)

  • AE

    9, 12, 18 and 24 month

Study Arms (3)

Usual care

NO INTERVENTION

Usual car accruing to guidelines

Individualized training

EXPERIMENTAL

Individualized exercise training program in addition to usual care

Behavioral: exercise training

Individualized training plus adherence measures

EXPERIMENTAL

Individualized exercise training plus measures to increase adherence

Behavioral: exercise trainingBehavioral: Adherence measures

Interventions

exercise trainingBEHAVIORAL

individualized exercise training

Individualized trainingIndividualized training plus adherence measures
Adherence measuresBEHAVIORAL

Measures to increase adherence to exercise training

Individualized training plus adherence measures

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcus Dörr

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marcus Dörr, MD

    University Greifswald

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Dörr, MD

CONTACT

+49 3834 8680500mdoerr@uni-greifswald.de

Stepahn B Felix, MD

CONTACT

+4938348680500felix@uni-greifswald.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

DE(1)