NCT02802462

Brief Summary

Exercise training improves endothelium-dependent vasodilation, whereas hypoxic stress causes vascular endothelial dysfunction. Monocyte- derived endothelial progenitor cells (Mon-EPCs) contribute to vascular repair process by differentiating into endothelial cells. This study investigates how high-intensity interval (HIT) and moderate intensity-continuous (MCT) exercise training affect circulating Mon-EPC levels and EPC functionality under hypoxic condition. Sixty healthy sedentary males were randomized to engage either HIT (3-minute intervals at 40% and 80%VO2max , n=20) or MCT (sustained 60%VO2max , n=20) for 30 minutes/day, 5 days/week for 6 weeks, or to a control group that did not received exercise intervention (n=20). Mon-EPC characteristics and EPC functionality under hypoxic exercise (HE, 100W under 12%O 2 ) were determined before and after various interventions.

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 Dec 2012

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

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

May 19, 2016

Last Update Submit

June 13, 2016

Conditions

Keywords

endothelial progenitor cellhemodynamicExerciseHIIT

Outcome Measures

Primary Outcomes (1)

  • Circulating progenitor cells conten

    by flow cytometry before and after rehabilitation circulating progenitor cells conten before and after hypoxic exercise test

    6 weeks

Secondary Outcomes (1)

  • Cardiopulmonary fitness

    6 weeks

Other Outcomes (3)

  • Cardiac hemodynamic measurement

    6 weeks

  • Cerebral hemodynamic measurement

    6 weeks

  • Muscular hemodynamic measurement

    6 weeks

Study Arms (3)

High intensity-interval (HIT)

EXPERIMENTAL
Behavioral: HIT

moderate intensity-continuous (MCT)

EXPERIMENTAL
Behavioral: MCT

control (CTL)

NO INTERVENTION

Interventions

HITBEHAVIORAL

3-minute intervals at 40% and 80%VO 2max

High intensity-interval (HIT)
MCTBEHAVIORAL

sustained 60%VO 2max

moderate intensity-continuous (MCT)

Eligibility Criteria

Age20 Years - 28 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary life
  • Age 20\~28

You may not qualify if:

  • Smokers
  • Users of medication/vitamins
  • Any cardiopulmonary/hematological risk
  • Regular exercise habits at least 1 year
  • Exposed to high altitudes (\>3000 m) for at least 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypoxiaMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jong-Shyan Wang, PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Rehabilitation Science

Study Record Dates

First Submitted

May 19, 2016

First Posted

June 16, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 16, 2016

Record last verified: 2016-06