- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05696990
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Brussels, Belgium, 1070
- Erasme Hospital
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-
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
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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
|
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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
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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)
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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.)
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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
|
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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
|
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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.
Sponsor
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.
General Publications
- Stragier S, Baudry S, Carpentier A, Duchateau J. Efficacy of a new strength training design: the 3/7 method. Eur J Appl Physiol. 2019 May;119(5):1093-1104. doi: 10.1007/s00421-019-04099-5. Epub 2019 Feb 12.
- Duchateau J, Stragier S, Baudry S, Carpentier A. Strength Training: In Search of Optimal Strategies to Maximize Neuromuscular Performance. Exerc Sport Sci Rev. 2021 Jan;49(1):2-14. doi: 10.1249/JES.0000000000000234.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2020/489
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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