HIIT and MICT on Nitric Oxide-mediated Erythrocyte Rheology

March 26, 2021 updated by: Jong-Shyan Wang, Chang Gung Memorial Hospital

Effects of High Intensity Interval Training and Moderate Intensity Continuous Training on Nitric Oxide-mediated Erythrocyte Rheology

Erythrocyte rheological properties affect blood viscoelasticity and consequently regulate vascular resistance to flow shear force, whereas rheological impairments of erythrocytes may result in circulatory disorders. The aim of this study was to establish an effective exercise strategy for improving individual aerobic capacity and for simultaneously ameliorating the risk of hemorheological dysfunction evoked by a graded exercise test (GXT) and the hypotheses is exercise intervention will improved hemorheological functions by enhancing deformability of erythrocytes via NO-mediated mechanism. This study included 60 healthy sedentary mens (age 20~30) from Chang Gung university than were randomized into the HIIT [3-min intervals at 40% and 80% V̇O2 reserve (V̇O2R),n=10] and MICT(sustained 60% V̇O2R,n=10)on a bicycle ergometer for 30min·d-1, 5 d·wk-1 for 6 wk.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Recently, the role of erythrocyte has been more emphasized, which also related with endothelial cell. For coronary artery patients, the endothelial nitric oxide synthase activity in red blood cell (RBC-eNOS activity) is lower than age-matched health people, and it is related with dysfunction of endothelial cell. In cardiovascular diseases. the erythrocyte arginase-1 is active and seize L-arginine with eNOS. When the Arg-1 stimulated by reactive oxygen species (ROS), the nitric oxide (NO) bioactivity decrease and produce more ROS, meanwhile, ROS can go around to stimulate Arg-1. When the RBC-NO production is lowering, it will increase the adhesion activity to endothelial cell due to erythrocyte can be quite close to blood vessel well then release Nitric Oxide, induce the dysfunction and oxidative pressure of endothelial cell. The NO can also regulate the deformability of erythrocytes, and extremely affect oxygen supply to tissue once the deformability and aggregation of erythrocyte become abnormal. Besides NO, the deformability will be affected if erythrocyte is continuously exposed to the endogenous or exogenous ROS, which also increase adhesion to endothelial cell with the exposure of phosphatidylserine. Exercise can regulate the mechanism of NO release from erythrocyte, affecting the rheology of erythrocyte, and improve the anti-oxidation ability. Therefore, as mentioned above which make erythrocyte, as many aspects, become an important role on atherosclerosis disease treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

Without any exercise training
No Intervention: Control group
Without any exercise training
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intracellular NO production response to exercise training.
Time Frame: 8 weeks
Added different inhibitors or agonists to investigate the effects of exercise training on NO production mediated by eNOS-NO pathway.
8 weeks
Intracellular ROS production response to exercise training.
Time Frame: 8 weeks
Added different inhibitors or agonists to investigate the effects of exercise training on ROS production mediated by eNOS-NO pathway.
8 weeks
The levels of eNOS, p-eNOS and Band-3 response to exercise training.
Time Frame: 8 weeks
Detect the following protein levels: eNOS, p-eNOS and Band-3, by the western blots.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of erythrocyte biological markers by Flow Cytometry
Time Frame: 8 weeks
Using the Flow Cytometry to detect the following markers: CD242, CD239, NADPH oxidase 2 (Nox2) and Arginase 1 (Arg1).
8 weeks
Erythrocyte deformability
Time Frame: 8 weeks
Isolated erythrocyte first, then assess erythrocyte deformability (elongation index ) by using laser assisted optical rotational red cell analyzer (LoRRca).
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 4, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202000448A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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