Skip to main content
OpenTrials
Completed

NCT Number: NCT05696990

3/7 Resistance Training Method in Cardiac Rehabilitation

Aim of the clinical monocentric study is to assess the resistance training exercise intervention in patients with Heart Failure with reduced Ejection Fraction (HFrEF) and coronary artery disease that will best improve peak oxygen uptake (Peak Vo2) and leg strength (assessed Isokinetic). The investigators hypothesize that resistance training exercise with induced a high stress metabolic is more important exercise with induced than a lower stress metabolic.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical Coronary artery diseases
  • Heart failure with reduced ejection fraction

Exclusion criteria

  • angina
  • acutely decompensated heart failure
  • electrocardiographic evidence of ischemia
  • significant valvular disease
  • orthopedic/neurologic disorders that limited exercise

Treatment and study plan

3/7 Resistance Training Method

Other

3/7 Resistance Training Method

3X9 Resistance Training Method

Other

3X9 Resistance Training Method

Primary outcomes

  1. Change in Peak VO2 after 3 months

    Time frame: Baseline and 3 months

    Change in Peak oxygen consumption (VO2) after three 3 months intervention

  2. Change in strength knee extensor after 3 months

    Time frame: Baseline and 3 months

    Change in strength knee extensor (60°/sec) after three months intervention

Secondary outcomes

  1. Change in VE/VCO2 slope after 3 months

    Time frame: Baseline and 3 months

    Change in ventilatory efficiency (VE/VCO2) slope at baseline and 3 months intervention

  2. Change in submaximal exercise capacity after 3 months

    Time frame: Baseline and 3 months

    Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)

  3. Change in workload maximal after 3 months

    Time frame: Baseline and 3 months

    Change in workload max at baseline and 3 months intervention

  4. Change in Body fat after 3 months

    Time frame: Baseline and 3 months

    Change in Body fat at baseline and 3 months intervention

  5. Change in lean mass after 3 months

    Time frame: Baseline and 3 months

    Change in lean mass at baseline and 3 months intervention

  6. Change in leg lean mass after 3 months

    Time frame: Baseline and 3 months

    Change in leg lean mass at baseline and 3 months intervention

  7. Change in bone mass after 3 months

    Time frame: Baseline and 3 months

    Change in bone mass at baseline and 3 months intervention

  8. Change in Visceral adipose tissue after 3 months

    Time frame: Baseline and 3 months

    Change in Visceral adipose tissue measure by Dual-energy X- ray absorptiometry (DEXA) at baseline and 3 months intervention

  9. Change in hand grip force after 3 months

    Time frame: Baseline and 3 months

    Change in hand grip force on non dominant hand at baseline and 3 months intervention

  10. Change in ventilation metaboreflex function after 3 months

    Time frame: Baseline and 3 months

    Change in ventilation during metaboreflex test at baseline and 3 months intervention (Briefly, the subject is asked to exercise with the non-dominant arm by performing two 5 min handgrip manoeu- vres reaching approximately 50% of pre-determined maximal con- traction, in random order, separated by a 30 min interval: one bout with circulatory occlusion during the last 10 s of exercise and the all 3 min recovery phase ('clamp session'). During the clamp session, forearm cuff inflation to 30 mmHg above systolic blood pressure from the last 10 s of exercise till the end of the 3 min recovery phase; after cuff inflation, the subject is instructed to relax. Ergore- ceptor sensitivity is quantified as the percentage of the ventilatory and haemodynamic response to exercise maintained by circulatory occlusion during the third minute compared with the third minute of basal recovery.)

  11. Change in diastolic blood pressure metaboreflex function after 3 months

    Time frame: Baseline and 3 months

    Change in diastolic blood pressure during metaboreflex test at baseline and 3 months intervention

  12. Change in heart rate at rest after 3 months

    Time frame: Baseline and 3 months

    Change in heart rate at baseline and 3 months intervention

  13. Change in resting heart rate variability at rest after 3 months

    Time frame: Baseline and 3 months

    Change in resting heart rate variability at baseline and 3 months intervention

  14. Change 30 s sit-to-stand after 3 months

    Time frame: Baseline and 3 months

    Change 30 s sit-to-stand at baseline and 3 months intervention

  15. Change in isometric strength knee extensor after 3 months

    Time frame: Baseline and 3 months

    Change in strength knee extensor (isometric) at baseline and 3 months intervention

  16. Change in 120°/sec strength knee extensor after 3 months

    Time frame: Baseline and 3 months

    Change in strength knee extensor (120°/sec) at baseline and 3 months intervention

  17. Change in 180°/sec strength knee extensor after 3 months

    Time frame: Baseline and 3 months

    Change in strength knee extensor (180°/sec) at baseline and 3 months intervention

  18. Change strength knee extensor in leg extension after 3 months

    Time frame: Baseline and 3 months

    Change in one repetition maximal in leg extensor machine at baseline and 3 months intervention

  19. Change in sub maximal strength knee extensor in leg extension after 3 months

    Time frame: Baseline and 3 months

    Change in 10 repetitions maximal in leg extensor machine at baseline and 3 months intervention

  20. Change in heart rate recovery after 3 months

    Time frame: Baseline and 3 months

    Change in heart rate recovery at baseline and 3 months intervention

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

3/7 Resistance Training Method in Cardiac Rehabilitation of Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.