Effect of Hypoxia Exercise on Erythrocyte Aggregability

March 16, 2021 updated by: Jong-Shyan Wang, Chang Gung Memorial Hospital
Pathological erythrocyte aggregation reduces capillary perfusion and oxygen transfer to tissue. The aggregation is determined by opposing forces, the repulsive force between cells, cell-to-cell adhesion induced by plasma fibrinogen, and the disaggregating shear force generated by blood flow. The investigators investigate how hypoxic exercise affects intrinsic/extrinsic factors of aggregation. Sixty sedentary males were randomly assigned into either hypoxic (HE; FiO2=15%, n=20) or normoxic (NE; FiO2=21%, n=20) training groups for 30 min·d-1, 5 d·wk-1 for 6 weeks at 60% of maximum work rate or to a control group (CTL; n=20). A hypoxia exercise test (HET, FiO2=12%) was performed before and after the intervention. The erythrocyte aggregation, binding affinity of fibrinogen and membrane biomarkers were determined by an ektacytometry and flow cytometry, respectively.

Study Overview

Status

Status

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

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

The aim of this study is to clarify the effects of exercise training with and without hypoxia on the erythrocyte aggregation, further providing a feasible strategy for developing an appropriate exercise regimen that improves cardiopulmonary fitness and minimizes the risk of hemorheological disorders. This study evaluated the distinct effects of hypoxic exercise training (HE) and normaxia exercise training (NE) for 6 weeks on the following issue: (1) intrinsic/extrinsic erythrocyte aggregation, (2) binding affinity of fibrinogen to erythrocyte, (3) erythrocyte turnover rate and (4) characteristic of mature erythrocytes in blood, under hypoxic exercise test (HET) (100W under air 12% O2 condition) in healthy sedentary men.

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 (Actual)

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

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: Normoxic exercise (NE)
The subjects were trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax) under 21%O2 in air (NE) for 30 minutes per day, 5 days per week for 6 weeks
Behavioral: Normoxic exercise
Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks
Experimental: Hypoxic exercise (HE)
The subjects were trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax) under 15%O2 in air (HE) for 30 minutes per day, 5 days per week for 6 weeks
Behavioral: Hypoxic exercise
Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks
No Intervention: Normoxic control
Without any exercise training

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
Total Erythrocyte Aggregation
Time Frame: 8 weeks
The total erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
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
Cardiopulmonary capacity
Time Frame: 8 weeks
To assess cardiopulmonary capacity, the 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). After 5-min baseline resting period records, a 2-min warm-up period (60 rpm, unloaded pedaling) was started and followed by an incremental work (30 W elevation for each 3-minute) until exhaustion (i.e., progressive exercise to maximal O2 consumption, VO2max).
8 weeks
The affinity between erythrocyte and fibrinogen
Time Frame: 8 weeks
  1. The erythrocyte suspension (1×10^6 cells/μl) was incubated with fibrinogen (400 mM) and anti-fibrinogen-FITC monoclonal antibody (1:500, Cedarlane) in the dark for 30 min at RT.
  2. After the staining is completed, add 1μl suspension into 100μl medium solution, then rotate the sample on a Viscometer (Brookfield) at different rates (0, 50, 100, 200, 400, 800 rpm) for 1 min at 37°C in the dark.
  3. The mean fluorescence intensity (MFI) obtained from 50,000 erythrocytes was measured by FACSCalibur (Becton Dickinson, New Jersey, USA).
8 weeks
Senescence-Related Molecules on Erythrocyte
Time Frame: 8 weeks
Erythrocyte suspensions (1x10^6 cells /µl) were incubated with monoclonal anti- CD147(eBioscience) and anti-CD47(BioLegend) that were conjugated with FITC in the dark for 30 min at 37°C. The MFI obtained from 50,000 erythrocytes was measured by using FACSCalibur.
8 weeks
Adhesion-Related Molecules on Erythrocyte
Time Frame: 8 weeks
Erythrocyte suspensions (1x10^6 cells /µl) were incubated with monoclonal anti-CD49d (eBioscience) and anti- CD36(BioLegend) that were conjugated with FITC in the dark for 30 min at 37°C. The MFI obtained from 50,000 erythrocytes was measured by using FACSCalibur.
8 weeks
The influences of fibrinogen to erythrocytes
Time Frame: 8 weeks
  1. The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
  2. The adjusted sample was pre-treated with 400 mM fibrinogen for 30 min.
  3. The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
8 weeks
The influences of the intrinsic factor to erythrocytes
Time Frame: 8 weeks
  1. The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
  2. The adjusted sample was pre-treated with 10 mM Dextran for 30 min.
  3. The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
8 weeks
The influences of the extrinsic factor to erythrocytes
Time Frame: 8 weeks
  1. The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
  2. For excluding the effect of changed plasma composition, the erythrocyte sample was added into the platelet-poor-plasma (PPP) collected before the hypoxia exercise test.
  3. The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
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

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.
July 5, 2010

Primary Completion (Actual)

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.
June 30, 2011

Study Completion (Actual)

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.
June 30, 2011

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 25, 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 16, 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 18, 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 18, 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 16, 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

Additional Relevant MeSH Terms

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.
  • 200903510B0

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings