HealthyNCT04815460
Aerobic Interval and Moderate Continuous Exercise Training on Ventricular Functions
A study testing High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT) in people with Healthy and High Intensity Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, High Intensity Interval Training, Exercise Training
- What is being tested?
- High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration < 20 min).
Who cannot join
- Exposed to high altitudes (> 3000 m) for at least 1 year.
- Smoker
- Taking medications or vitamins
- Having any cardiopulmonary/hematological risk.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Healthy, High Intensity Interval Training, Exercise Training
- Being tested
- High intensity-interval training (HIIT), Moderate intensity-continuous (MICT)
- Keywords
- Stress echocardiography, Hypoxia test, Speckle-tracking echocardiography, High Intensity Interval Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity-interval training (HIIT)Behavioural
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)Behavioural
Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Moderate intensity-continuous (MICT) |
| Control group | No intervention | Without any exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (5)
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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)
Measured: 8 weeks
RV diastolic function
Doppler imaging was used to measure peak tricuspid annular (E') and flow velocities (E) in early diastole.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start1 Jul 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung University
- Responsible party
- Principal investigator, Jong-Shyan Wang, Chang Gung Memorial Hospital
- Investigators
- Jong-Shyan Wang, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815460
- Sponsor's protocol ID
- 104-9615A3
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23666792Jaijee 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.
PubMed 29775415Huang 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.
PubMed 30829901Naeije R, Badagliacca R. The overloaded right heart and ventricular interdependence. Cardiovasc Res. 2017 Oct 1;113(12):1474-1485. doi: 10.1093/cvr/cvx160.
PubMed 28957537Fu 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.
PubMed 22197120
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Interval and Moderate Continuous Exercise Training on Ventricular Functions
- ClinicalTrials.gov ID
- NCT04815460
- Acronym / sponsor ID
- 104-9615A3
- Conditions
- Healthy, High Intensity Interval Training, Exercise Training
- Keywords
- Stress echocardiography, Hypoxia test, Speckle-tracking echocardiography, High Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung University
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity-interval training (HIIT) | Experimental | 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 (MCT) | Experimental | Behavioral: 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. |
| Control group | No intervention | –Without any exercise training |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration < 20 min).
Key exclusion criteria (4 listed)
- Exposed to high altitudes (> 3000 m) for at least 1 year.
- Smoker
- Taking medications or vitamins
- Having any cardiopulmonary/hematological risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | High intensity-interval training (HIIT) |
| 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. | Behavioural | Ｍoderate intensity-continuous (MCT) |
Primary outcome
The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain
Time frame: 8 weeks
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.
The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain rate
Time frame: 8 weeks
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.
5 secondary outcomes
Cardiopulmonary fitness
Time frame: 8 weeks
The cavity diameters of RV
Time frame: 8 weeks
Pulmonary vascular resistance (PVR)
Time frame: 8 weeks
RV diastolic function
Time frame: 8 weeks
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Background: PubMed 23666792Wang 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.
- Background: PubMed 29775415Jaijee 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.
- Background: PubMed 30829901Huang 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.
- Background: PubMed 28957537Naeije R, Badagliacca R. The overloaded right heart and ventricular interdependence. Cardiovasc Res. 2017 Oct 1;113(12):1474-1485. doi: 10.1093/cvr/cvx160.
- Background: PubMed 22197120Fu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Shyan Wang, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity-interval training (HIIT) and Moderate intensity-continuous (MICT) in people with Healthy and High Intensity Interval Training, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of right cardiac mechanics during hypoxia stress echocardiography: Strain (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04815460, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.