NCT04805359

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2011

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

February 25, 2021

Last Update Submit

March 16, 2021

Conditions

Keywords

ErythrocyteAggregation

Outcome Measures

Primary Outcomes (1)

  • Total Erythrocyte Aggregation

    The total erythrocyte aggregation was determined by using Microfluidic Ektacytometer (Rheoscan-AnD 300, RheoMeditech, Seoul, Korea).

    8 weeks

Secondary Outcomes (7)

  • Cardiopulmonary capacity

    8 weeks

  • The affinity between erythrocyte and fibrinogen

    8 weeks

  • Senescence-Related Molecules on Erythrocyte

    8 weeks

  • Adhesion-Related Molecules on Erythrocyte

    8 weeks

  • The influences of fibrinogen to erythrocytes

    8 weeks

  • +2 more secondary outcomes

Study Arms (3)

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

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

Behavioral: Hypoxic exercise

Normoxic control

NO INTERVENTION

Without any exercise training

Interventions

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

Normoxic exercise (NE)

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 exercise (HE)

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

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

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

February 25, 2021

First Posted

March 18, 2021

Study Start

July 5, 2010

Primary Completion

June 30, 2011

Study Completion

June 30, 2011

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share