HypoxiaNCT04805359
Effect of Hypoxia Exercise on Erythrocyte Aggregability
A study testing Normoxic exercise and Hypoxic exercise in people with Hypoxia and Training, run by Chang Gung Memorial Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- Normoxic exercise and Hypoxic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2010to 30 Jun 2011
- 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.
About this study
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.
Read the 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.
- Being tested
- Normoxic exercise, Hypoxic exercise
- Keywords
- Erythrocyte, Aggregation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normoxic exerciseBehavioural
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
Hypoxic exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Normoxic exercise (NE) | Experimental | 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 Receives: Behavioral: Normoxic exercise |
| Hypoxic exercise (HE) | Experimental | 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 Receives: Behavioral: Hypoxic exercise |
| Normoxic control | No intervention | Without any exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Erythrocyte Aggregation
The total erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
Measured: 8 weeks
Secondary outcomes (7)
Cardiopulmonary capacity
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).
Measured: 8 weeks
The affinity between erythrocyte and fibrinogen
- 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.
- 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.
- The mean fluorescence intensity (MFI) obtained from 50,000 erythrocytes was measured by FACSCalibur (Becton Dickinson, New Jersey, USA).
Measured: 8 weeks
Senescence-Related Molecules on Erythrocyte
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.
Measured: 8 weeks
Adhesion-Related Molecules on Erythrocyte
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.
Measured: 8 weeks
The influences of fibrinogen to erythrocytes
- The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
- The adjusted sample was pre-treated with 400 mM fibrinogen for 30 min.
- The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
Measured: 8 weeks
The influences of the intrinsic factor to erythrocytes
- The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
- The adjusted sample was pre-treated with 10 mM Dextran for 30 min.
- The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
Measured: 8 weeks
The influences of the extrinsic factor to erythrocytes
- The hematocrit (Hct) of erythrocyte sample was adjusted to 40% to eliminate the effect of dehydration after exercise.
- 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.
- The erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
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 posted18 Mar 2021
- Study start5 Jul 2010
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT04805359
- Sponsor's protocol ID
- 200903510B0
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypoxia Exercise on Erythrocyte Aggregability
- ClinicalTrials.gov ID
- NCT04805359
- Acronym / sponsor ID
- 200903510B0
- Keywords
- Erythrocyte, Aggregation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jul 2010 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 18 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normoxic exercise (NE) | Experimental | Behavioral: Normoxic exerciseThe 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 |
| Hypoxic exercise (HE) | Experimental | Behavioral: Hypoxic exerciseThe 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 |
| Normoxic control | 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 |
|---|---|---|
| Normoxic exerciseTrained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks | Behavioural | Normoxic exercise (NE) |
| Hypoxic exerciseTrained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks | Behavioural | Hypoxic exercise (HE) |
Primary outcome
Total Erythrocyte Aggregation
Time frame: 8 weeks
The total erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).
7 secondary outcomes
Cardiopulmonary capacity
Time frame: 8 weeks
The affinity between erythrocyte and fibrinogen
Time frame: 8 weeks
Senescence-Related Molecules on Erythrocyte
Time frame: 8 weeks
Adhesion-Related Molecules on Erythrocyte
Time frame: 8 weeks
The influences of fibrinogen to erythrocytes
Time frame: 8 weeks
The influences of the intrinsic factor to erythrocytes
Time frame: 8 weeks
The influences of the extrinsic factor to erythrocytes
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 18 Mar 2021.
- 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
Questions about this trial
What is this clinical trial studying?
A study testing Normoxic exercise and Hypoxic exercise in people with Hypoxia and Training, run by Chang Gung Memorial Hospital.
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 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Total Erythrocyte Aggregation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2021; AzTrials last refreshed its copy on 3 Nov 2026.