NCT04815460

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 22, 2021

Last Update Submit

March 23, 2021

Conditions

HealthyHigh Intensity Interval TrainingExercise Training

Keywords

Stress echocardiographyHypoxia testSpeckle-tracking echocardiographyHigh Intensity Interval Training

Outcome Measures

Primary Outcomes (2)

  • The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain

    1. Hypoxia stress echocardiography was collected under hypoxic conditions (12% FiO2) and used two-dimensional Speckle-tracking echocardiography. 2. The resting images were acquired after the subject was placed in the aforementioned position for 10 min. 3. 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). 4. A modified apical four-chamber view was used to assess 2D-STE longitudinal and radial parameters of the RV and RA. 5. The RV strain was calculated using the average peak segmental values displayed by the software using a 6-segment model.

    8 weeks

  • The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain rate

    1. Hypoxia stress echocardiography was collected under hypoxic conditions (12% FiO2) and used two-dimensional Speckle-tracking echocardiography. 2. The resting images were acquired after the subject was placed in the aforementioned position for 10 min. 3. 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). 4. A modified apical four-chamber view was used to assess 2D-STE longitudinal and radial parameters of the RV and RA. 5. The RV strain rate was calculated using the average peak segmental values displayed by the software using a 6-segment model.

    8 weeks

Secondary Outcomes (5)

  • Cardiopulmonary fitness

    8 weeks

  • The cavity diameters of RV

    8 weeks

  • Pulmonary vascular resistance (PVR)

    8 weeks

  • RV diastolic function

    8 weeks

  • Tricuspid annular plane systolic excursion (TAPSE)

    8 weeks

Study Arms (3)

High intensity-interval training (HIIT)

EXPERIMENTAL

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.

Behavioral: High intensity-interval training (HIIT)

Ｍoderate intensity-continuous (MCT)

EXPERIMENTAL

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

Behavioral: Moderate intensity-continuous (MICT)

Control group

NO INTERVENTION

Without any exercise training

Interventions

High intensity-interval training (HIIT)BEHAVIORAL

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.

High intensity-interval training (HIIT)
Moderate intensity-continuous (MICT)BEHAVIORAL

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

Ｍoderate intensity-continuous (MCT)

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration \< 20 min).

You may not qualify if:

  • Exposed to high altitudes (\> 3000 m) for at least 1 year.
  • Smoker
  • Taking medications or vitamins
  • Having any cardiopulmonary/hematological risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 23666792BACKGROUND

  • 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.

    PMID: 29775415BACKGROUND

  • 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.

    PMID: 30829901BACKGROUND

  • 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.

    PMID: 28957537BACKGROUND

  • 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.

    PMID: 22197120BACKGROUND

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jong-Shyan Wang, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 25, 2021

Study Start

July 1, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)