- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02802462
High-intensity Interval Training Enhances Mobilization/Functionality of Endothelial Progenitor Cells and Depressed Shedding of Vascular Endothelial Cells Undergoing Hypoxia
June 13, 2016 updated by: Jong-Shyan Wang, Chang Gung Memorial Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High intensity-interval (HIT)
|
3-minute intervals at 40% and 80%VO 2max
|
Experimental: moderate intensity-continuous (MCT)
|
sustained 60%VO 2max
|
No Intervention: control (CTL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulating progenitor cells conten
Time Frame: 6 weeks
|
by flow cytometry before and after rehabilitation circulating progenitor cells conten before and after hypoxic exercise test
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiopulmonary fitness
Time Frame: 6 weeks
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac hemodynamic measurement
Time Frame: 6 weeks
|
evaluate cardiac hemodynamic response to exercise by noninvasive continuous cardiac output monitoring system
|
6 weeks
|
Cerebral hemodynamic measurement
Time Frame: 6 weeks
|
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
|
Muscular hemodynamic measurement
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
May 19, 2016
First Submitted That Met QC Criteria
June 13, 2016
First Posted (Estimate)
June 16, 2016
Study Record Updates
Last Update Posted (Estimate)
June 16, 2016
Last Update Submitted That Met QC Criteria
June 13, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101-0408A3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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