- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03717948
Examining the Impact of Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males
July 11, 2019 updated by: Brendon Gurd, Queen's University
Examining the Impact of Acute Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males: A Randomized Cross-over Trial
This crossover study investigates the effects of restricting arterial blood flow during cycling exercise on PGC-1α and its upstream signalling pathways.
In a randomized order, participants will exercise once for 30 minutes with restricted blood flow and then will exercise once for 30 minutes with no blood flow restriction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L3N6
- Queen's University
-
-
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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 3 hours of physical activity per week
- No previous cycling training
- No concurrent involvement in another training program
- Body mass index < 30 kg/m2
Exclusion Criteria:
- Presence of cardiovascular disease
- Presence of metabolic disease
- Taking regular oral medication
- Current smoker
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CTL - BFR
CTL Exercise then BFR Exercise
|
Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
Participants will exercise on a recumbent bike placed on flat ground (CTL).
|
Experimental: BFR - CTL
BFR Exercise then CTL Exercise
|
Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
Participants will exercise on a recumbent bike placed on flat ground (CTL).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA)
Time Frame: 15 minutes before exercise and 3 hours post-exercise for both exercise sessions
|
Fold-change in PGC-1α mRNA expression
|
15 minutes before exercise and 3 hours post-exercise for both exercise sessions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catecholamine concentrations
Time Frame: 15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Catecholamine concentrations in venous blood
|
15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Total and phosphorylated p38 mitogen-activated protein kinase (MAPK)
Time Frame: 15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Fold change in p38 MAPK phosphorylation
|
15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Total and phosphorylated acetyl coenzyme A carboxylase (ACC)
Time Frame: 15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Fold change in ACC phosphorylation
|
15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Total and phosphorylated protein kinase A (PKA)
Time Frame: 15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Fold change in PKA phosphorylation
|
15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Acetylated p53
Time Frame: 15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Fold change in acetylated p53
|
15 minutes before exercise and immediately post-exercise for both exercise sessions
|
Blood lactate
Time Frame: During both exercise sessions (lactate); 15 minutes before and immediately after both exercise sessions
|
Average [lactate] between conditions
|
During both exercise sessions (lactate); 15 minutes before and immediately after both exercise sessions
|
Heart rate (HR)
Time Frame: During both exercise sessions
|
Average HR between conditions
|
During both exercise sessions
|
Revolutions per minute (RPM)
Time Frame: During both exercise sessions
|
Average RPM between conditions
|
During both exercise sessions
|
Ratings of perceived exertion (RPE)
Time Frame: During both exercise sessions
|
Average RPE between conditions
|
During both exercise sessions
|
Oxygenated and deoxygenated hemoglobin
Time Frame: During both exercise sessions and up to 10 minutes after (for cuff occlusion)
|
Average oxygenated and deoxygenated hemoglobin as a percentage of same day max values
|
During both exercise sessions and up to 10 minutes after (for cuff occlusion)
|
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 (Actual)
October 1, 2018
Primary Completion (Actual)
January 28, 2019
Study Completion (Actual)
January 28, 2019
Study Registration Dates
First Submitted
October 19, 2018
First Submitted That Met QC Criteria
October 22, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
July 15, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BFRNP
- 402635 (Other Grant/Funding Number: NSERC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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