- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815460
Aerobic Interval and Moderate Continuous Exercise Training on Ventricular Functions
Study Overview
Status
Intervention / Treatment
Detailed Description
Hypoxic exposure increases right ventricular (RV) afterload by triggering pulmonary hypertension, with consequent effects on the structure and function of the RV. Improved myocardial contractility is a critical circulatory adaptation to exercise training. However, the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet been identified. This study investigated how high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) influence right cardiac mechanics during hypoxic exercise (HE).
The young and healthy sedentary males were randomly selected to engage in either HIIT (3-min intervals at 40% and 80% of VO2 oxygen uptake reserve) or MICT (sustained 60% of VO2 oxygen uptake reserve) for 30 min/day and 5 days/week for 6 weeks or were included in a control group (CTL) that did not engage in any exercise. Right cardiac mechanics during semiupright bicycle exercise tests under hypoxic conditions (i.e., 50 watts under 12% FiO2 for 3 min) were measured using two-dimensional speckle-tracking echocardiography. The primary outcome was the change in right cardiac mechanics during semiupright bicycle exercise under hypoxic conditions (i.e., 50 watts under 12% FiO2 for 3 min) as measured by two-dimensional speckle tracking echocardiography.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taoyuan, Taiwan, 333
- Chang Gung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration < 20 min).
Exclusion Criteria:
- Exposed to high altitudes (> 3000 m) for at least 1 year.
- Smoker
- Taking medications or vitamins
- Having any cardiopulmonary/hematological risk.
Study Plan
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: High intensity-interval training (HIIT)
Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
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Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
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Experimental: Moderate intensity-continuous (MCT)
Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
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Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
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No Intervention: Control group
Without any exercise training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain
Time Frame: 8 weeks
|
|
8 weeks
|
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The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain rate
Time Frame: 8 weeks
|
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiopulmonary fitness
Time Frame: 8 weeks
|
To assess cardiopulmonary fitness, cardiopulmonary exercise test (CPET) on a cycle ergometer was performed 4 days before and after the intervention.
All subjects underwent exercise with a mask to measured oxygen consumption (VO2) breath by breath using a computer-based system (Master Screen CPX, Cardinal-health Germany).
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8 weeks
|
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The cavity diameters of RV
Time Frame: 8 weeks
|
RV basal cavity diameter (RVD1), mid-cavity diameter (RVD2), and RV longitudinal diameter (RVD3), at end-diastole and end-systole, were evaluated in the modified apical four-chamber view.
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8 weeks
|
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Pulmonary vascular resistance (PVR)
Time Frame: 8 weeks
|
Pulmonary vascular resistance (PVR) was calculated using the formula PVR = ([tricuspid regurgitation velocity/RVOT VTI] × 10 + 0.16)
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8 weeks
|
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RV diastolic function
Time Frame: 8 weeks
|
Doppler imaging was used to measure peak tricuspid annular (E') and flow velocities (E) in early diastole.
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8 weeks
|
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Tricuspid annular plane systolic excursion (TAPSE)
Time Frame: 8 weeks
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Tricuspid annular plane systolic excursion (TAPSE) measures the longitudinal excursion of the tricuspid annulus in one dimension, which was measured by M-mode.
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8 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Fu TC, Wang CH, Lin PS, Hsu CC, Cherng WJ, Huang SC, Liu MH, Chiang CL, Wang JS. Aerobic interval training improves oxygen uptake efficiency by enhancing cerebral and muscular hemodynamics in patients with heart failure. Int J Cardiol. 2013 Jul 15;167(1):41-50. doi: 10.1016/j.ijcard.2011.11.086. Epub 2011 Dec 22.
- Wang Z, Chesler NC. Pulmonary vascular mechanics: important contributors to the increased right ventricular afterload of pulmonary hypertension. Exp Physiol. 2013 Aug;98(8):1267-73. doi: 10.1113/expphysiol.2012.069096. Epub 2013 May 10.
- Jaijee S, Quinlan M, Tokarczuk P, Clemence M, Howard LSGE, Gibbs JSR, O'Regan DP. Exercise cardiac MRI unmasks right ventricular dysfunction in acute hypoxia and chronic pulmonary arterial hypertension. Am J Physiol Heart Circ Physiol. 2018 Oct 1;315(4):H950-H957. doi: 10.1152/ajpheart.00146.2018. Epub 2018 May 18.
- Huang YC, Tsai HH, Fu TC, Hsu CC, Wang JS. High-Intensity Interval Training Improves Left Ventricular Contractile Function. Med Sci Sports Exerc. 2019 Jul;51(7):1420-1428. doi: 10.1249/MSS.0000000000001931.
- Naeije R, Badagliacca R. The overloaded right heart and ventricular interdependence. Cardiovasc Res. 2017 Oct 1;113(12):1474-1485. doi: 10.1093/cvr/cvx160.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 104-9615A3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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