NCT07636343

Brief Summary

The goal of this interventional study is to assess the training effects in a training schedule in which eccentric overload training and eccentric cycle training are used. Researchers will compare a training program of eccentric overload training and eccentric cycling training with a traditional training program of strength and cardio training in people with heart failure with reduced ejection fraction. This study will be delivered in a cardiac rehabilitation setting.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress89%
Jan 2023Jan 2027

Study Start

First participant enrolled

January 20, 2023

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

December 1, 2025

Last Update Submit

June 3, 2026

Conditions

Keywords

eccentric muscle training

Outcome Measures

Primary Outcomes (6)

  • 1Repetition Maximum (=RM) leg press (kg)

    One repetition maximum on leg press device Technogym BioCircuit. The patient is positioned correctly on the leg press (back supported, feet on platform in standardized way so that repeated tests are in the same position). The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg).

    pre (baseline) + post (15 weeks)

  • 1Repetition Maximum (=RM) Low Row (kg)

    One repetition maximum on the low row device Technogym BioCircuit. The patient sits with chest supported, feet on the ground, and grips the handles with arms extended. The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single lift as the 1RM (kg).

    pre (baseline) + post (15weeks)

  • 1Repetition Maximum (=RM) chest press (kg)

    One repetition maximum on chest press device Technogym BioCircuit. The patient is positioned correctly on the chest press (back supported, feet on the ground in standardized way so that repeated tests are in the same position). The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg).

    pre (baseline) + post (15weeks)

  • 1Repetition Maximum (=RM) vertical traction (kg)

    One repetition maximum on vertical traction device Technogym BioCircuit. The patient is positioned correctly on the vertical traction (back supported, feet on the ground in standardized way so that repeated tests are in the same position). The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg).

    pre (baseline) + post (15weeks)

  • Handgrip strength

    The Jamar handgrip dynamometer is used to measure grip strength in a standardized way ( 90° flex elbow, forearm neutral, and wrist slightly extended). 3 trials per hand are performed, with 10seconds rest in between. The average value is recorded as grip strength.

    pre (baseline) + post (15 weeks)

  • Isometric Qceps peak torque (Nm)

    The subject is seated in the Biodex System dynamometer and securely strapped (trunk, pelvis, thigh). The dynamometer axis is aligned with the knee joint axis (lateral femoral epicondyle). The knee is fixed at 60° of flexion (0° = full extension). The lower leg is attached to the lever arm just above the ankle. The subject performs a maximal isometric knee extension (pushing against the immovable arm) for 3seconds. 3 tests are done with 10seconds rest in between. The highest torque value (Nm) recorded is taken as the quadriceps peak torque.

    pre (baseline) + post (15weeks)

Secondary Outcomes (6)

  • 6mwt (m)

    pre (baseline) - post (15weeks)

  • Time up and go (s)

    pre (baseline) + post (15weeks)

  • VO2 peak (ml/kg/min)

    pre (baseline) + post (15weeks)

  • maximal load (Watt)

    pre (baseline) + post (15weeks)

  • VO2/W slope (ml/min/W)

    pre (baseline) + post (15weeks)

  • +1 more secondary outcomes

Study Arms (2)

Eccentric strength training + cardio

EXPERIMENTAL

45 sessions experimental protocol

Other: eccentric bike trainingOther: eccentric overload trainingOther: aerobic treadmill training

Traditional strength training + cardio

ACTIVE COMPARATOR

45 sessions traditional cardiac rehabilitation

Other: aerobic treadmill trainingOther: aerobic bike trainingOther: traditional dynamic strength training

Interventions

progressive following protocol, 10min

Eccentric strength training + cardio

dynamic strength training + eccentric overload, progressive over time, 3sets\*10reps (15-20min)

Eccentric strength training + cardio

aerobic training, progressive over time, 10 min

Eccentric strength training + cardioTraditional strength training + cardio

aerobic training, progressive following protocol, 10 min

Traditional strength training + cardio

dynamic strength training, progression over time, 15-20 min

Traditional strength training + cardio

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • HFrEF patients with ejection fraction \<40%
  • Exercise intolerance (\<85% of predicted VO2 peak)
  • clinically stable for \> 6 weeks, optimal medical treatment for \> 6 weeks

You may not qualify if:

  • Contra indications for cardiac exercise rehabilitation as per consensus guidelines and recommendations
  • Musculoskeletal disorders that hamper (progression in) strength training
  • Non-stabilized acute coronary syndrome
  • Current acute heart failure (decompensation)
  • Patient having sustained a recent (\<3 months) procedure that could act as a confounder to increase VO2peak (i.e., coronary artery bypass graft surgery, percutaneous coronary intervention, cardiac resynchronization therapy, valve surgery or reparation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHAntwerp

Edegem, 2850, Belgium

RECRUITING

Central Study Contacts

Wendy Hens, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

June 9, 2026

Study Start

January 20, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

depending on collaboration - if in line with privacy policy this might be done

Locations