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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CTL - BFR
CTL Exercise then BFR Exercise
Other: BFR Exercise
Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
Other: CTL Exercise
Participants will exercise on a recumbent bike placed on flat ground (CTL).
Experimental: BFR - CTL
BFR Exercise then CTL Exercise
Other: BFR Exercise
Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
Other: CTL Exercise
Participants will exercise on a recumbent bike placed on flat ground (CTL).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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