The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation
Primary Purpose
Heart Failure, Resistance Training, Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cardiac rehabilitation with 3/7 method
Cardiac rehabilitation with 3X9 method
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Cardiac rehabilition, exercise therapy, metabolic stress
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
Experimental
Arm Label
CAD group
HFrEF group
Arm Description
Coronary artery diseases
Heart Failure with reduced Ejection Fraction
Outcomes
Primary Outcome Measures
Change in Lactate
mmol/l
change in Testosterone
nmol/l
change Glucocorticoid Cortisol
nmol/l
change in Growth Hormone
ng/ml
change in ph
venoust
change PCO2 venoust
mm Hg
Secondary Outcome Measures
Borg scale
Borg Rating of Perceived Exertion - Borg modified (0 = no exertion at all -10 maximal exertion)
Pleasure of the session scale
0 = worse 10 = better
Full Information
NCT ID
NCT05391620
First Posted
April 7, 2022
Last Updated
October 4, 2022
Sponsor
Université Libre de Bruxelles
1. Study Identification
Unique Protocol Identification Number
NCT05391620
Brief Title
The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation
Official Title
Acute Effects of the 3/7 Method and 3X9 Method in Resistance Training on Testosterone, Glucocorticoid Cortisol, Growth Hormone and Lactate in Heart Failure and Coronary Artery Disease During Cardiac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
February 20, 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
The study proposes to measure the effect of resitance training (RT) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population.
3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). This method is compare to 3X9 method, 3 series of 9 repetitions with inter-set (1min).The training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of ~ 70% of one repetition maximal (1RM).
Before these trainings all subject perform HIIT on bicycles (2 min high intensity (80% Wmax) and 2 min low intensity (50% Wmax) during 30 minutes.
The investigators collect blood sample before exercice, after HIIT and after RT.
It is randomized cross-over study.
Detailed Description
The subjects come on two different days minimum 2 days and maximum 10 days between the two tests. They were instructed to avoid exercise the day before they participated in the study.
The investigators collect blood 2 minutes after endurance training (HIIT) and 2 min after RT training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Resistance Training, Coronary Artery Disease
Keywords
Cardiac rehabilition, exercise therapy, metabolic stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAD group
Arm Type
Experimental
Arm Description
Coronary artery diseases
Arm Title
HFrEF group
Arm Type
Experimental
Arm Description
Heart Failure with reduced Ejection Fraction
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation with 3/7 method
Other Intervention Name(s)
3/7 method
Intervention Description
HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3/7 method 3 rep (15 sec of rest), 4 rep (15 sec), 5 rep (15 sec), 6 rep (15 sec), 7 rep. (total volume : 25 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.
1 minute between each machine is planned.
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation with 3X9 method
Other Intervention Name(s)
3X9 method
Intervention Description
HIIT ( 2 min 80% wmax: 2 min 50% wmax) during 30 minutes 3X9 method 9 rep 1 minute of rest, 9 rep (1 min) and 9 rep (total volume : 27 repetitions) at 70 of 1 repetition Leg press, Dips Press, Leg curl, Traction and Leg extension.
1 minute between each machine is planned
Primary Outcome Measure Information:
Title
Change in Lactate
Description
mmol/l
Time Frame
within 2 minutes after TR training session on day 1
Title
change in Testosterone
Description
nmol/l
Time Frame
within 2 minutes after TR training session on day 1
Title
change Glucocorticoid Cortisol
Description
nmol/l
Time Frame
within 2 minutes after TR training session on day 1
Title
change in Growth Hormone
Description
ng/ml
Time Frame
within 2 minutes after TR training session on day 1
Title
change in ph
Description
venoust
Time Frame
within 2 minutes after TR training session on day 1
Title
change PCO2 venoust
Description
mm Hg
Time Frame
within 2 minutes after TR training session on day 1
Secondary Outcome Measure Information:
Title
Borg scale
Description
Borg Rating of Perceived Exertion - Borg modified (0 = no exertion at all -10 maximal exertion)
Time Frame
within 4 minutes after TR training session on day 1
Title
Pleasure of the session scale
Description
0 = worse 10 = better
Time Frame
within 4 minutes after TR training session on day 1
10. Eligibility
Sex
Male
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
025558386
Ext
58386
Email
alexis.gillet@ulb.be
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe van de borne, Professor
Email
philippe.van.de.borne@erasme.ulb.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe van de borne, Professor
Organizational Affiliation
Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium
Official's Role
Study Director
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
on request
Citations:
PubMed Identifier
35394146
Citation
Mang ZA, Realzola RA, Ducharme J, Bellissimo GF, Beam JR, Mermier C, de Castro Magalhaes F, Kravitz L, Amorim FT. The effect of repetition tempo on cardiovascular and metabolic stress when time under tension is matched during lower body exercise. Eur J Appl Physiol. 2022 Jun;122(6):1485-1495. doi: 10.1007/s00421-022-04941-3. Epub 2022 Apr 8.
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The Effect of the 3/7 vs 3X9 Method in Resistance Training on Metabolic Stress in Cardiac Rehabilitation
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