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Recruiting NCT07636343

Eccentric Muscle Training in Cardiac Rehabilitation

No phase Interventional Strength Training Effects HFrEF - Heart Failure With Reduced Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eccentric bike training, eccentric overload training, aerobic treadmill training, aerobic bike training.
Who it may be relevant to
Registry conditions: Strength Training Effects, HFrEF - Heart Failure With Reduced Ejection Fraction. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction

Overview

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.

Detailed description

Patients with HFrEF experience in general more difficulties completing exercise training trajectory because of low physical fitness and multiple comorbidies.

In this study traditional exercise capacity outcomes are assessed eg. endurance capacity, muscle strength and muscle mass in patients with HFrEF.

It is hypothesized that greater muscle strength and muscle mass are obtained by eccentric muscle training in comparison with conventional training because higher training volumes can be used with a lower metabolic demand.

Possibly, a better outcome regarding muscle function and mass will influence VO2 peak and functionality in this patient population.

Interventions

  • Other eccentric bike training
    progressive following protocol, 10min
  • Other eccentric overload training
    dynamic strength training + eccentric overload, progressive over time, 3sets\*10reps (15-20min)
  • Other aerobic treadmill training
    aerobic training, progressive over time, 10 min
  • Other aerobic bike training
    aerobic training, progressive following protocol, 10 min
  • Other traditional dynamic strength training
    dynamic strength training, progression over time, 15-20 min

Primary outcome measures

  • 1Repetition Maximum (=RM) leg press (kg) [Time frame: pre (baseline) + post (15 weeks)]
  • 1Repetition Maximum (=RM) Low Row (kg) [Time frame: pre (baseline) + post (15weeks)]
  • 1Repetition Maximum (=RM) chest press (kg) [Time frame: pre (baseline) + post (15weeks)]
  • 1Repetition Maximum (=RM) vertical traction (kg) [Time frame: pre (baseline) + post (15weeks)]
  • Handgrip strength [Time frame: pre (baseline) + post (15 weeks)]
  • Isometric Qceps peak torque (Nm) [Time frame: pre (baseline) + post (15weeks)]
Secondary outcome measures (6)
  • 6mwt (m) [Time frame: pre (baseline) - post (15weeks)]
  • Time up and go (s) [Time frame: pre (baseline) + post (15weeks)]
  • VO2 peak (ml/kg/min) [Time frame: pre (baseline) + post (15weeks)]
  • maximal load (Watt) [Time frame: pre (baseline) + post (15weeks)]
  • VO2/W slope (ml/min/W) [Time frame: pre (baseline) + post (15weeks)]
  • VE/VCO2 slope [Time frame: pre (baseline) + post (15weeks)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • UHAntwerp — Edegem

Identifiers

NCT: NCT07636343 · EDGE 002632 · Belgian Heart Fund

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗