- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05205538
Does Biological Sex Influence the Cardiac Output Response to Sprint Interval Exercise Training in Humans?
April 4, 2023 updated by: Martin Gibala, McMaster University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
21
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
-
Hamilton, Ontario, Canada, L8S4K1
- McMaster 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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Females
Female participant group
|
A 10-minute sprint interval exercise training protocol that is performed three times per week for a total of 12 weeks.
|
|
Experimental: Males
Male participant group
|
A 10-minute sprint interval exercise training protocol that is performed three times per week for a total of 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak cardiac output
Time Frame: Change from baseline after 12 weeks of sprint interval exercise training
|
Peak cardiac output measured during exercise
|
Change from baseline after 12 weeks of sprint interval exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak oxygen uptake
Time Frame: Change from baseline after 12 weeks of sprint interval exercise training
|
Peak oxygen uptake measured during exercise
|
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
|
Brachial artery flow mediated dilation
|
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
|
Central and peripheral pulse wave velocity
|
Change from baseline after 4 and 12 weeks of sprint interval exercise training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 25, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
December 23, 2021
First Submitted That Met QC Criteria
January 11, 2022
First Posted (Actual)
January 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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