3/7 Resistance Training Method in Cardiac Rehabilitation

February 13, 2024 updated by: Alexis Gillet, Université Libre de Bruxelles

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

      • Brussels, Belgium, 1070
        • Erasme Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3/7 RT method
perform interval- type endurance exercise at high intensity and resistance training with the 3/7 method
3/7 Resistance Training Method
Active Comparator: 3X9 RT method
perform interval- type endurance exercise at high intensity and resistance training with the 3X9 method
3X9 Resistance Training Method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak VO2 after 3 months
Time Frame: Baseline and 3 months
Change in Peak oxygen consumption (VO2) after three 3 months intervention
Baseline and 3 months
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
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 3 months
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)
Baseline and 3 months
Change in workload maximal after 3 months
Time Frame: Baseline and 3 months
Change in workload max at baseline and 3 months intervention
Baseline and 3 months
Change in Body fat after 3 months
Time Frame: Baseline and 3 months
Change in Body fat at baseline and 3 months intervention
Baseline and 3 months
Change in lean mass after 3 months
Time Frame: Baseline and 3 months
Change in lean mass at baseline and 3 months intervention
Baseline and 3 months
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
Baseline and 3 months
Change in bone mass after 3 months
Time Frame: Baseline and 3 months
Change in bone mass at baseline and 3 months intervention
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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.)
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months
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
Baseline and 3 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Alexis Gillet, Université libre de Bruxelles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 1, 2019

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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