Mitochondrial BiogenesisNCT03717948
Examining the Impact of Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males
A study testing BFR Exercise and CTL Exercise in people with Mitochondrial Biogenesis, run by Queen's University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Biogenesis
- What is being tested?
- BFR Exercise and CTL Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 3 hours of physical activity per week
- No previous cycling training
- No concurrent involvement in another training program
- Body mass index < 30 kg/m2
Who cannot join
- Presence of cardiovascular disease
- Presence of metabolic disease
- Taking regular oral medication
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mitochondrial Biogenesis
- Being tested
- BFR Exercise, CTL Exercise
- Keywords
- Acute Exercise, Mitochondria, Skeletal Muscle, PGC1α, Mitochondrial Biogenesis, Intracellular Signalling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR ExerciseOther
Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
CTL ExerciseOther
Participants will exercise on a recumbent bike placed on flat ground (CTL).
| Study group | Role | What they receive |
|---|---|---|
| CTL - BFR | Experimental | CTL Exercise then BFR Exercise Receives: Other: BFR Exercise; Other: CTL Exercise |
| BFR - CTL | Experimental | BFR Exercise then CTL Exercise Receives: Other: BFR Exercise; Other: CTL Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) messenger ribonucleic acid (mRNA)
Fold-change in PGC-1α mRNA expression
Measured: 15 minutes before exercise and 3 hours post-exercise for both exercise sessions
Secondary outcomes (10)
Catecholamine concentrations
Catecholamine concentrations in venous blood
Measured: 15 minutes before exercise and immediately post-exercise for both exercise sessions
Total and phosphorylated p38 mitogen-activated protein kinase (MAPK)
Fold change in p38 MAPK phosphorylation
Measured: 15 minutes before exercise and immediately post-exercise for both exercise sessions
Total and phosphorylated acetyl coenzyme A carboxylase (ACC)
Fold change in ACC phosphorylation
Measured: 15 minutes before exercise and immediately post-exercise for both exercise sessions
Total and phosphorylated protein kinase A (PKA)
Fold change in PKA phosphorylation
Measured: 15 minutes before exercise and immediately post-exercise for both exercise sessions
Acetylated p53
Fold change in acetylated p53
Measured: 15 minutes before exercise and immediately post-exercise for both exercise sessions
Blood lactate
Average [lactate] between conditions
Measured: During both exercise sessions (lactate); 15 minutes before and immediately after both exercise sessions
Heart rate (HR)
Average HR between conditions
Measured: During both exercise sessions
Revolutions per minute (RPM)
Average RPM between conditions
Measured: During both exercise sessions
Ratings of perceived exertion (RPE)
Average RPE between conditions
Measured: During both exercise sessions
Oxygenated and deoxygenated hemoglobin
Average oxygenated and deoxygenated hemoglobin as a percentage of same day max values
Measured: During both exercise sessions and up to 10 minutes after (for cuff occlusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Oct 2018
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial BiogenesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brendon Gurd, Queen's University
- Investigators
- Brendon J Gurd, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03717948
- Sponsor's protocol ID
- BFRNP
- Other IDs
- 402635
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of Acute Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males: A Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03717948
- Acronym / sponsor ID
- BFRNP
- Conditions
- Mitochondrial Biogenesis
- Keywords
- Acute Exercise, Mitochondria, Skeletal Muscle, PGC1α, Mitochondrial Biogenesis, Intracellular Signalling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTL - BFR | Experimental | Other: BFR Exercise, Other: CTL ExerciseCTL Exercise then BFR Exercise |
| BFR - CTL | Experimental | Other: BFR Exercise, Other: CTL ExerciseBFR Exercise then CTL Exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 3 hours of physical activity per week
- No previous cycling training
- No concurrent involvement in another training program
- Body mass index < 30 kg/m2
Key exclusion criteria (4 listed)
- Presence of cardiovascular disease
- Presence of metabolic disease
- Taking regular oral medication
- Current smoker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFR ExerciseParticipants will exercise on a recumbent bike placed on a 45 degree incline (BFR). | Other | BFR - CTL, CTL - BFR |
| CTL ExerciseParticipants will exercise on a recumbent bike placed on flat ground (CTL). | Other | BFR - CTL, CTL - BFR |
Primary outcome
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
10 secondary outcomes
Catecholamine concentrations
Time frame: 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
Total and phosphorylated acetyl coenzyme A carboxylase (ACC)
Time frame: 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
Acetylated p53
Time frame: 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
Heart rate (HR)
Time frame: During both exercise sessions
Revolutions per minute (RPM)
Time frame: During both exercise sessions
Ratings of perceived exertion (RPE)
Time frame: During both exercise sessions
Oxygenated and deoxygenated hemoglobin
Time frame: During both exercise sessions and up to 10 minutes after (for cuff occlusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Related trials for Mitochondrial Biogenesis
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Recruiting
Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility
Idiopathic Infertility, Infertility Unexplained
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendon J Gurd, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR Exercise and CTL Exercise in people with Mitochondrial Biogenesis, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.