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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02802462
Other study ID # 101-0408A3
Secondary ID
Status Completed
Phase N/A
First received May 19, 2016
Last updated June 13, 2016
Start date December 2012
Est. completion date December 2013

Study information

Verified date June 2016
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 28 Years
Eligibility Inclusion Criteria:

- Sedentary life

- Age 20~28

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
HIT
3-minute intervals at 40% and 80%VO 2max
MCT
sustained 60%VO 2max

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Cardiac hemodynamic measurement evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system 6 weeks No
Other Cerebral hemodynamic measurement Two pairs of near infrared probes were attached to each subject to monitor the absorption of near infrared light across left frontal cortex during graded exercise test 6 weeks No
Other Muscular hemodynamic measurement Two pairs of near infrared probes were attached to each subject to monitor the absorption of near infrared light across left vastus lateralis muscle during graded exercise test 6 weeks No
Primary Circulating progenitor cells conten by flow cytometry before and after rehabilitation circulating progenitor cells conten before and after hypoxic exercise test 6 weeks No
Secondary Cardiopulmonary fitness 6 weeks No
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