Mitochondrial BiogenesisNCT04151095
Examining The Effect of Blood Flow Restricted Aerobic Training on Mitochondrial Adaptations in Young Healthy Adults
A study testing BFR Exercise Training and CTL Exercise Training in people with Mitochondrial Biogenesis, run by Brendon Gurd, PhD at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Biogenesis
- What is being tested?
- BFR Exercise Training and CTL Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2019to 13 Dec 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
- All sexes
- 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 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.
- Conditions
- Mitochondrial Biogenesis
- Being tested
- BFR Exercise Training, CTL Exercise Training
- Keywords
- Mitochondria, Exercise training, VO2, Aerobic exercise, Citrate Synthase, Blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR Exercise TrainingOther
Participants will complete exercise training on a recumbent bike placed on a 45 degree incline (BFR).
CTL Exercise TrainingOther
Participants will complete exercise training on a recumbent bike placed on flat ground (CTL).
| Study group | Role | What they receive |
|---|---|---|
| BFR | Experimental | Not described Receives: Other: BFR Exercise Training |
| CTL | Experimental | Not described Receives: Other: CTL Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Citrate Synthase
Fold change in citrate synthase maximal activity
Measured: 3 days prior to start of exercise training and 3 days after completing exercise training
Secondary outcomes (11)
Transcription factor A, mitochondrial (TFAM)
Fold change in TFAM protein
Measured: 3 days before training to 3 days after training
Nuclear respiratory factor, 1 (NRF1)
Fold change in NRF-1 protein
Measured: 3 days before training to 3 days after training
Maximal oxygen consumption (VO2peak)
Change in VO2peak (POST-PRE)
Measured: 3 days before training to 3 days after training
Heart rate (HR)
Average HR
Measured: Every 5 minutes during each of the 7, 30-minute exercise sessions
Revolutions per minute (RPM)
Average RPM
Measured: Every 5 minutes during each of the 7, 30-minute exercise sessions
Blood [lactate]
Average blood lactate concentration
Measured: During all exercise sessions at 10 and 30 minutes
Rating of perceived exertion (RPE)
Average RPE
Measured: Every 5 minutes during each of the 7, 30-minute exercise sessions
Nuclear Factor, Erythroid 2 Like 2 (NFE2L2)
Fold change in NFE2L2
Measured: 3 days before training to 3 days after training
Cytochrome c oxidase (COX)
Fold change in COX
Measured: 3 days before training to 3 days after training
Electromyography (EMG)
Median frequency and average amplitude of EMG signal
Measured: Throughout each of the 7, 30-minute exercise sessions
Near-infrared spectroscopy (NIRS)
Deoxygenated hemoglobin and oxygenated hemoglobin
Measured: Throughout each of the 7, 30-minute exercise sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start6 May 2019
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brendon Gurd, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brendon Gurd, PhD, Queen's University
- Investigators
- Brendon J Gurd, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151095
- Sponsor's protocol ID
- BFRT
- Status last verified
- Dec 2023
- First submitted
- 2 Apr 2019
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Preobrazenski N, Mladen SPS, Causer E, Menezes E, Islam H, Drouin PJ, Tschakovsky ME, Gurd BJ. Mitochondrial and cardiovascular responses to aerobic exercise training in supine and upright positions in healthy young adults: a randomized parallel arm trial. Transl Exerc Biomed. 2025 Mar 26;2(1):9-20. doi: 10.1515/teb-2025-0002. eCollection 2025 May.
PubMed 40224168
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining The Effect of Blood Flow Restricted Aerobic Training on Citrate Synthase Activity in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT04151095
- Acronym / sponsor ID
- BFRT
- Conditions
- Mitochondrial Biogenesis
- Keywords
- Mitochondria, Exercise training, VO2, Aerobic exercise, Citrate Synthase, Blood flow restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brendon Gurd, PhDUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 5 Nov 2019 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR | Experimental | Other: BFR Exercise Training |
| CTL | Experimental | Other: CTL Exercise Training |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- 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 Exercise TrainingParticipants will complete exercise training on a recumbent bike placed on a 45 degree incline (BFR). | Other | BFR |
| CTL Exercise TrainingParticipants will complete exercise training on a recumbent bike placed on flat ground (CTL). | Other | CTL |
Primary outcome
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
11 secondary outcomes
Transcription factor A, mitochondrial (TFAM)
Time frame: 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
Maximal oxygen consumption (VO2peak)
Time frame: 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
Revolutions per minute (RPM)
Time frame: 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
Rating of perceived exertion (RPE)
Time frame: 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
Cytochrome c oxidase (COX)
Time frame: 3 days before training to 3 days after training
Electromyography (EMG)
Time frame: Throughout each of the 7, 30-minute exercise sessions
Near-infrared spectroscopy (NIRS)
Time frame: Throughout each of the 7, 30-minute exercise sessions
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 26 Dec 2023.
- Derived from this study: PubMed 40224168Preobrazenski N, Mladen SPS, Causer E, Menezes E, Islam H, Drouin PJ, Tschakovsky ME, Gurd BJ. Mitochondrial and cardiovascular responses to aerobic exercise training in supine and upright positions in healthy young adults: a randomized parallel arm trial. Transl Exerc Biomed. 2025 Mar 26;2(1):9-20. doi: 10.1515/teb-2025-0002. eCollection 2025 May.
- Individual participant dataSharing planned: Undecided
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 Training and CTL Exercise Training in people with Mitochondrial Biogenesis, run by Brendon Gurd, PhD 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 26 Dec 2023. 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?
Citrate Synthase (time frame: 3 days prior to start of exercise training and 3 days after completing exercise training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151095, which also lists 1 linked publication.
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 26 Dec 2023.