NCT04823429

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 5, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

February 26, 2021

Last Update Submit

March 26, 2021

Conditions

ExerciseInterval Training

Keywords

ErythrocyteeNOSHigh intensity interval trainingdeformability

Outcome Measures

Primary Outcomes (3)

  • Intracellular NO production response to exercise training.

    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.

    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.

    Detect the following protein levels: eNOS, p-eNOS and Band-3, by the western blots.

    8 weeks

Secondary Outcomes (3)

  • Determination of erythrocyte biological markers by Flow Cytometry

    8 weeks

  • Erythrocyte deformability

    8 weeks

  • Cardiopulmonary fitness

    8 weeks

Study Arms (3)

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.

Behavioral: High intensity-interval training (HIIT)

Moderate intensity-continuous (MICT)

EXPERIMENTAL

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)

Control group

NO INTERVENTION

Without any exercise training

Interventions

High intensity-interval training (HIIT)BEHAVIORAL

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

High intensity-interval training (HIIT)
Moderate intensity-continuous (MICT)BEHAVIORAL

Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.

Moderate intensity-continuous (MICT)

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

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (6)

  • Mao TY, Fu LL, Wang JS. Hypoxic exercise training causes erythrocyte senescence and rheological dysfunction by depressed Gardos channel activity. J Appl Physiol (1985). 2011 Aug;111(2):382-91. doi: 10.1152/japplphysiol.00096.2011. Epub 2011 May 5.

    PMID: 21551009BACKGROUND

  • Agre P, King LS, Yasui M, Guggino WB, Ottersen OP, Fujiyoshi Y, Engel A, Nielsen S. Aquaporin water channels--from atomic structure to clinical medicine. J Physiol. 2002 Jul 1;542(Pt 1):3-16. doi: 10.1113/jphysiol.2002.020818.

    PMID: 12096044BACKGROUND

  • Wang JS, Fu TC, Lien HY, Wang CH, Hsu CC, Wu WC, Chien YW, Cherng WJ. Effect of aerobic interval training on erythrocyte rheological and hemodynamic functions in heart failure patients with anemia. Int J Cardiol. 2013 Sep 30;168(2):1243-50. doi: 10.1016/j.ijcard.2012.11.053. Epub 2012 Nov 27.

    PMID: 23199556BACKGROUND

  • Chou SL, Huang YC, Fu TC, Hsu CC, Wang JS. Cycling Exercise Training Alleviates Hypoxia-Impaired Erythrocyte Rheology. Med Sci Sports Exerc. 2016 Jan;48(1):57-65. doi: 10.1249/MSS.0000000000000730.

    PMID: 26672920BACKGROUND

  • Grau M, Pauly S, Ali J, Walpurgis K, Thevis M, Bloch W, Suhr F. RBC-NOS-dependent S-nitrosylation of cytoskeletal proteins improves RBC deformability. PLoS One. 2013;8(2):e56759. doi: 10.1371/journal.pone.0056759. Epub 2013 Feb 12.

    PMID: 23424675BACKGROUND

  • Suhr F, Brenig J, Muller R, Behrens H, Bloch W, Grau M. Moderate exercise promotes human RBC-NOS activity, NO production and deformability through Akt kinase pathway. PLoS One. 2012;7(9):e45982. doi: 10.1371/journal.pone.0045982. Epub 2012 Sep 25.

    PMID: 23049912BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jong-Shyan Wang, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Shyan Wang, PhD

CONTACT

+886-3-2118800s5492@mail.cgu.edu.tw

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 26, 2021

First Posted

March 30, 2021

Study Start

March 5, 2021

Primary Completion

September 4, 2021

Study Completion

September 4, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)