ExerciseNCT05205538
Does Biological Sex Influence the Cardiac Output Response to Sprint Interval Exercise Training in Humans?
A study testing Sprint interval exercise training in people with Exercise, run by McMaster University at 1 site in Canada.
Trial summary
Sprint interval exercise training refers to brief repeated bouts of vigorous effort that are separated by short periods of recovery. Cardiac output refers to the amount of blood that is pumped out of the heart each minute. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Sprint interval exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2022to 28 Feb 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being untrained based on a self-report of engaging in < 1 h of weekly moderate to vigorous physical activity based on the Canadian Society for Exercise Physiology Get Active Questionnaire.
- Having an estimated cardiorespiratory fitness in the lower 50% of adults in the specified age range based on the online fitness calculator available at: www.worldfitnesslevel.org.
- Females who are naturally cycling (i.e., not using any form of hormonal contraceptive) or are using a 2nd generation oral contraceptive.
Who cannot join
- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
- Females with a positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Sprint interval exercise training refers to brief repeated bouts of vigorous effort that are separated by short periods of recovery. Cardiac output refers to the amount of blood that is pumped out of the heart each minute. Research has shown that sprint interval exercise training can increase peak cardiac output - or the highest cardiac output that is achieved during strenuous exercise - but this response may be influenced by biological sex. The primary goal of this study is to determine whether the peak cardiac output response to 12 weeks of sprint interval exercise training differs between males and females. Cardiac output will be estimated using a non-invasive technique that involves breathing in a mixture of standardized gases. This research will help to determine whether biological sex influences the response of the heart to brief vigorous cycle exercise training.
Read the detailed description
The primary purpose of this study is to determine whether biological sex influences the peak cardiac output response to 12 weeks of sprint interval exercise training. Peak cardiac output will be determined non-invasively using an inert gas rebreathing technique. Each session of sprint interval exercise training will involve a 10-minute period of cycling on a stationary ergometer. The protocol will consist of a two-minute warm-up; three, 20-second 'all out' efforts that are separated by two minutes of recovery; and a three-minute cool down. Three sessions of training will be performed each week for a total of 12 weeks. Groups of male and female participants will be recruited and tested using best practice guidelines for sex-based comparisons of exercise responses. The study will advance knowledge regarding the potential for biological sex to influence the cardiovascular response to brief vigorous cycle exercise training.
- Conditions
- Exercise
- Being tested
- Sprint interval exercise training
- Keywords
- Cardiac output
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint interval exercise trainingOther
A 10-minute sprint interval exercise training protocol that is performed three times per week for a total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Females | Experimental | Female participant group Receives: Other: Sprint interval exercise training |
| Males | Experimental | Male participant group Receives: Other: Sprint interval exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cardiac output
Peak cardiac output measured during exercise
Measured: Change from baseline after 12 weeks of sprint interval exercise training
Secondary outcomes (3)
Peak oxygen uptake
Peak oxygen uptake measured during exercise
Measured: Change from baseline after 12 weeks of sprint interval exercise training
Flow mediated dilation
Brachial artery flow mediated dilation
Measured: Change from baseline after 4 and 12 weeks of sprint interval exercise training
Pulse wave velocity
Central and peripheral pulse wave velocity
Measured: Change from baseline after 4 and 12 weeks of sprint interval exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start25 Jan 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Gibala, McMaster University
- Investigators
- Martin Gibala, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205538
- Sponsor's protocol ID
- 14279
- Status last verified
- Apr 2023
- First submitted
- 23 Dec 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Biological Sex Influence the Cardiac Output Response to Sprint Interval Exercise Training in Humans?
- ClinicalTrials.gov ID
- NCT05205538
- Acronym / sponsor ID
- 14279
- Conditions
- Exercise
- Keywords
- Cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 Jan 2022 (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.
Sprint interval exercise training refers to brief repeated bouts of vigorous effort that are separated by short periods of recovery. Cardiac output refers to the amount of blood that is pumped out of the heart each minute. Research has shown that sprint interval exercise training can increase peak cardiac output - or the highest cardiac output that is achieved during strenuous exercise - but this response may be influenced by biological sex. The primary goal of this study is to determine whether the peak cardiac output response to 12 weeks of sprint interval exercise training differs between males and females. Cardiac output will be estimated using a non-invasive technique that involves breathing in a mixture of standardized gases. This research will help to determine whether biological sex influences the response of the heart to brief vigorous cycle exercise training.
Detailed description
The primary purpose of this study is to determine whether biological sex influences the peak cardiac output response to 12 weeks of sprint interval exercise training. Peak cardiac output will be determined non-invasively using an inert gas rebreathing technique. Each session of sprint interval exercise training will involve a 10-minute period of cycling on a stationary ergometer. The protocol will consist of a two-minute warm-up; three, 20-second 'all out' efforts that are separated by two minutes of recovery; and a three-minute cool down. Three sessions of training will be performed each week for a total of 12 weeks. Groups of male and female participants will be recruited and tested using best practice guidelines for sex-based comparisons of exercise responses. The study will advance knowledge regarding the potential for biological sex to influence the cardiovascular response to brief vigorous cycle exercise training.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females | Experimental | Other: Sprint interval exercise trainingFemale participant group |
| Males | Experimental | Other: Sprint interval exercise trainingMale participant group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being untrained based on a self-report of engaging in < 1 h of weekly moderate to vigorous physical activity based on the Canadian Society for Exercise Physiology Get Active Questionnaire.
- Having an estimated cardiorespiratory fitness in the lower 50% of adults in the specified age range based on the online fitness calculator available at: www.worldfitnesslevel.org.
- Females who are naturally cycling (i.e., not using any form of hormonal contraceptive) or are using a 2nd generation oral contraceptive.
Key exclusion criteria (2 listed)
- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
- Females with a positive pregnancy test.
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 |
|---|---|---|
| Sprint interval exercise trainingA 10-minute sprint interval exercise training protocol that is performed three times per week for a total of 12 weeks. | Other | Females, Males |
Primary outcome
Peak cardiac output
Time frame: Change from baseline after 12 weeks of sprint interval exercise training
Peak cardiac output measured during exercise
3 secondary outcomes
Peak oxygen uptake
Time frame: Change from baseline after 12 weeks of sprint interval exercise training
Flow mediated dilation
Time frame: Change from baseline after 4 and 12 weeks of sprint interval exercise training
Pulse wave velocity
Time frame: Change from baseline after 4 and 12 weeks of sprint interval exercise training
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 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Martin Gibala, PhD principal investigator
McMaster 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 Sprint interval exercise training in people with Exercise, run by McMaster 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 3 inclusion and 2 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 6 Apr 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?
Peak cardiac output (time frame: Change from baseline after 12 weeks of sprint interval exercise training). 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 6 Apr 2023.