Back to results3/7 Resistance Training Method in Cardiac Rehabilitation
Primary Purpose
Heart Failure, Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
3/7 Resistance Training Method
3X9 Resistance Training Method
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring cardiac rehabilitation, resistance training, strength training, exercise for older adults
Eligibility Criteria
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
Sites / Locations
- Erasme HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3/7 RT method
3X9 RT method
Arm Description
perform interval- type endurance exercise at high intensity and resistance training with the 3/7 method
perform interval- type endurance exercise at high intensity and resistance training with the 3X9 method
Outcomes
Primary Outcome Measures
Change in Peak VO2 after 3 months
Change in Peak oxygen consumption (VO2) after three 3 months intervention
Change in strength knee extensor after 3 months
Change in strength knee extensor (60°/sec) after three months intervention
Secondary Outcome Measures
Change in VE/VCO2 slope after 3 months
Change in ventilatory efficiency (VE/VCO2) slope at baseline and 3 months intervention
Change in submaximal exercise capacity after 3 months
Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)
Change in workload maximal after 3 months
Change in workload max at baseline and 3 months intervention
Change in Body fat after 3 months
Change in Body fat at baseline and 3 months intervention
Change in lean mass after 3 months
Change in lean mass at baseline and 3 months intervention
Change in leg lean mass after 3 months
Change in leg lean mass at baseline and 3 months intervention
Change in bone mass after 3 months
Change in bone mass at baseline and 3 months intervention
Change in Visceral adipose tissue after 3 months
Change in Visceral adipose tissue measure by Dual-energy X- ray absorptiometry (DEXA) at baseline and 3 months intervention
Change in hand grip force after 3 months
Change in hand grip force on non dominant hand at baseline and 3 months intervention
Change in ventilation metaboreflex function after 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.)
Change in diastolic blood pressure metaboreflex function after 3 months
Change in diastolic blood pressure during metaboreflex test at baseline and 3 months intervention
Change in heart rate at rest after 3 months
Change in heart rate at baseline and 3 months intervention
Change in resting heart rate variability at rest after 3 months
Change in resting heart rate variability at baseline and 3 months intervention
Change 30 s sit-to-stand after 3 months
Change 30 s sit-to-stand at baseline and 3 months intervention
Change in isometric strength knee extensor after 3 months
Change in strength knee extensor (isometric) at baseline and 3 months intervention
Change in 120°/sec strength knee extensor after 3 months
Change in strength knee extensor (120°/sec) at baseline and 3 months intervention
Change in 180°/sec strength knee extensor after 3 months
Change in strength knee extensor (180°/sec) at baseline and 3 months intervention
Change strength knee extensor in leg extension after 3 months
Change in one repetition maximal in leg extensor machine at baseline and 3 months intervention
Change in sub maximal strength knee extensor in leg extension after 3 months
Change in 10 repetitions maximal in leg extensor machine at baseline and 3 months intervention
Change in heart rate recovery after 3 months
Change in heart rate recovery at baseline and 3 months intervention
Full Information
NCT ID
NCT05696990
First Posted
January 11, 2023
Last Updated
January 20, 2023
Sponsor
Université Libre de Bruxelles
1. Study Identification
Unique Protocol Identification Number
NCT05696990
Brief Title
3/7 Resistance Training Method in Cardiac Rehabilitation
Official Title
3/7 Resistance Training Method in Cardiac Rehabilitation of Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Libre de Bruxelles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Coronary Artery Disease
Keywords
cardiac rehabilitation, resistance training, strength training, exercise for older adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3/7 RT method
Arm Type
Experimental
Arm Description
perform interval- type endurance exercise at high intensity and resistance training with the 3/7 method
Arm Title
3X9 RT method
Arm Type
Active Comparator
Arm Description
perform interval- type endurance exercise at high intensity and resistance training with the 3X9 method
Intervention Type
Other
Intervention Name(s)
3/7 Resistance Training Method
Intervention Description
3/7 Resistance Training Method
Intervention Type
Other
Intervention Name(s)
3X9 Resistance Training Method
Intervention Description
3X9 Resistance Training Method
Primary Outcome Measure Information:
Title
Change in Peak VO2 after 3 months
Description
Change in Peak oxygen consumption (VO2) after three 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in strength knee extensor after 3 months
Description
Change in strength knee extensor (60°/sec) after three months intervention
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in VE/VCO2 slope after 3 months
Description
Change in ventilatory efficiency (VE/VCO2) slope at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in submaximal exercise capacity after 3 months
Description
Submaximal exercise capacity will be measured using watts at the first ventilatory threshold (VT1)
Time Frame
Baseline and 3 months
Title
Change in workload maximal after 3 months
Description
Change in workload max at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in Body fat after 3 months
Description
Change in Body fat at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in lean mass after 3 months
Description
Change in lean mass at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in leg lean mass after 3 months
Description
Change in leg lean mass at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in bone mass after 3 months
Description
Change in bone mass at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in Visceral adipose tissue after 3 months
Description
Change in Visceral adipose tissue measure by Dual-energy X- ray absorptiometry (DEXA) at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in hand grip force after 3 months
Description
Change in hand grip force on non dominant hand at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in ventilation metaboreflex function after 3 months
Description
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.)
Time Frame
Baseline and 3 months
Title
Change in diastolic blood pressure metaboreflex function after 3 months
Description
Change in diastolic blood pressure during metaboreflex test at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in heart rate at rest after 3 months
Description
Change in heart rate at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in resting heart rate variability at rest after 3 months
Description
Change in resting heart rate variability at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change 30 s sit-to-stand after 3 months
Description
Change 30 s sit-to-stand at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in isometric strength knee extensor after 3 months
Description
Change in strength knee extensor (isometric) at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in 120°/sec strength knee extensor after 3 months
Description
Change in strength knee extensor (120°/sec) at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in 180°/sec strength knee extensor after 3 months
Description
Change in strength knee extensor (180°/sec) at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change strength knee extensor in leg extension after 3 months
Description
Change in one repetition maximal in leg extensor machine at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in sub maximal strength knee extensor in leg extension after 3 months
Description
Change in 10 repetitions maximal in leg extensor machine at baseline and 3 months intervention
Time Frame
Baseline and 3 months
Title
Change in heart rate recovery after 3 months
Description
Change in heart rate recovery at baseline and 3 months intervention
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Gillet, Pt, Msc
Phone
+3225558386
Email
alexis.gillet@erasme.ulb.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe van de borne, Professor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Gillet
Organizational Affiliation
Université Libre de Bruxelles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Gillet, Msc
Phone
025558386
Email
alexis.gillet@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Forton Kevin, PhD
Phone
025555016
Email
kevin.forton@ulb.be
12. IPD Sharing Statement
Citations:
PubMed Identifier
30756168
Citation
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.
Results Reference
background
PubMed Identifier
33044332
Citation
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.
Results Reference
background
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3/7 Resistance Training Method in Cardiac Rehabilitation
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