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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04815460
Other study ID # 104-9615A3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date June 30, 2017

Study information

Verified date March 2021
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date June 30, 2017
Est. primary completion date June 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 30 Years
Eligibility 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 Design


Intervention

Behavioral:
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.
Moderate intensity-continuous (MICT)
Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (3)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital Chang Gung University, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain Hypoxia stress echocardiography was collected under hypoxic conditions (12% FiO2) and used two-dimensional Speckle-tracking echocardiography.
The resting images were acquired after the subject was placed in the aforementioned position for 10 min.
The exercise images were conducted using semirecumbent cycling with a 50-Watt resistance for 3 min and acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR (i.e., HR changes <10 bpm within 10 s and <110-120 bpm).
A modified apical four-chamber view was used to assess 2D-STE longitudinal and radial parameters of the RV and RA.
The RV strain was calculated using the average peak segmental values displayed by the software using a 6-segment model.
8 weeks
Primary The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain rate Hypoxia stress echocardiography was collected under hypoxic conditions (12% FiO2) and used two-dimensional Speckle-tracking echocardiography.
The resting images were acquired after the subject was placed in the aforementioned position for 10 min.
The exercise images were conducted using semirecumbent cycling with a 50-Watt resistance for 3 min and acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR (i.e., HR changes <10 bpm within 10 s and <110-120 bpm).
A modified apical four-chamber view was used to assess 2D-STE longitudinal and radial parameters of the RV and RA.
The RV strain rate was calculated using the average peak segmental values displayed by the software using a 6-segment model.
8 weeks
Secondary Cardiopulmonary fitness 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). 8 weeks
Secondary The cavity diameters of RV 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. 8 weeks
Secondary Pulmonary vascular resistance (PVR) Pulmonary vascular resistance (PVR) was calculated using the formula PVR = ([tricuspid regurgitation velocity/RVOT VTI] × 10 + 0.16)
Tricuspid regurgitation velocity: Doppler imaging was used to measure peak tricuspid regurgitation velocities in systolic phase.
The RV outflow tract (RVOT): obtained from a parasternal short-axis base view modified apical four-chamber view, and the flow immediately proximal to the pulmonary artery valve during systole was detected to calculate both maximal velocity and pulsed-wave blood velocity time integral (VTI)
8 weeks
Secondary RV diastolic function Doppler imaging was used to measure peak tricuspid annular (E') and flow velocities (E) in early diastole. 8 weeks
Secondary Tricuspid annular plane systolic excursion (TAPSE) Tricuspid annular plane systolic excursion (TAPSE) measures the longitudinal excursion of the tricuspid annulus in one dimension, which was measured by M-mode. 8 weeks
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