- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151095
Examining The Effect of Blood Flow Restricted Aerobic Training on Mitochondrial Adaptations in Young Healthy Adults
December 19, 2023 updated by: Brendon Gurd, PhD
Examining The Effect of Blood Flow Restricted Aerobic Training on Citrate Synthase Activity in Young Healthy Adults
This parallel-arm trial study investigates the effects of restricting arterial blood flow during cycling exercise on citrate synthase.
Participants will be randomized to either a blood flow restricted or non-blood flow restricted exercise training group.
Both groups will complete seven, 30-minute exercise sessions over a 14-day period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
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
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BFR
|
Participants will complete exercise training on a recumbent bike placed on a 45 degree incline (BFR).
|
Experimental: CTL
|
Participants will complete exercise training on a recumbent bike placed on flat ground (CTL).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Citrate Synthase
Time Frame: 3 days prior to start of exercise training and 3 days after completing exercise training
|
Fold change in citrate synthase maximal activity
|
3 days prior to start of exercise training and 3 days after completing exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transcription factor A, mitochondrial (TFAM)
Time Frame: 3 days before training to 3 days after training
|
Fold change in TFAM protein
|
3 days before training to 3 days after training
|
Nuclear respiratory factor, 1 (NRF1)
Time Frame: 3 days before training to 3 days after training
|
Fold change in NRF-1 protein
|
3 days before training to 3 days after training
|
Maximal oxygen consumption (VO2peak)
Time Frame: 3 days before training to 3 days after training
|
Change in VO2peak (POST-PRE)
|
3 days before training to 3 days after training
|
Heart rate (HR)
Time Frame: Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Average HR
|
Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Revolutions per minute (RPM)
Time Frame: Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Average RPM
|
Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Blood [lactate]
Time Frame: During all exercise sessions at 10 and 30 minutes
|
Average blood lactate concentration
|
During all exercise sessions at 10 and 30 minutes
|
Rating of perceived exertion (RPE)
Time Frame: Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Average RPE
|
Every 5 minutes during each of the 7, 30-minute exercise sessions
|
Nuclear Factor, Erythroid 2 Like 2 (NFE2L2)
Time Frame: 3 days before training to 3 days after training
|
Fold change in NFE2L2
|
3 days before training to 3 days after training
|
Cytochrome c oxidase (COX)
Time Frame: 3 days before training to 3 days after training
|
Fold change in COX
|
3 days before training to 3 days after training
|
Electromyography (EMG)
Time Frame: Throughout each of the 7, 30-minute exercise sessions
|
Median frequency and average amplitude of EMG signal
|
Throughout each of the 7, 30-minute exercise sessions
|
Near-infrared spectroscopy (NIRS)
Time Frame: Throughout each of the 7, 30-minute exercise sessions
|
Deoxygenated hemoglobin and oxygenated hemoglobin
|
Throughout each of the 7, 30-minute exercise sessions
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brendon J Gurd, PhD, Queen's University
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)
May 6, 2019
Primary Completion (Actual)
December 13, 2019
Study Completion (Actual)
December 13, 2019
Study Registration Dates
First Submitted
April 2, 2019
First Submitted That Met QC Criteria
November 1, 2019
First Posted (Actual)
November 5, 2019
Study Record Updates
Last Update Posted (Actual)
December 26, 2023
Last Update Submitted That Met QC Criteria
December 19, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BFRT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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