Improved VO2max and Cardiac Output in Response to TrainingNCT04449016
Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training
A study testing High intensity interval training in people with Improved VO2max and Cardiac Output in Response to Training, run by California State University, San Marcos at 1 site in United States.
Trial summary
The purpose of this study was to determine if ethnicity alters training responsiveness to a low dose of high intensity interval training in inactive women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Improved VO2max and Cardiac Output in Response to Training
- What is being tested?
- High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 23 Mar 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Between the age of 18-45
- Healthy and non-obese (BMI < 30 kg/m2)
- Perform less than 150 minutes per week of exercise in the last 12 months
- 100% Caucasian or 100% Hispanic
Who cannot join
- Injured
- Obese
- Active
- Mixed ethnicity
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University San Marcos
San Marcos, California, 92096
About this study
The purpose of this study was to determine if ethnicity alters training responsiveness to a low dose of high intensity interval training in inactive women.
Read the detailed description
Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9 sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is well-tolerated in inactive individuals. Continuously during each session, heart rate was monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to training, as well as post.
- Being tested
- High intensity interval training
- Keywords
- HIIT, Inactive, Women
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
Repeated, brief, and intense exercise bouts separated by active recovery
| Study group | Role | What they receive |
|---|---|---|
| Caucasian | Experimental | Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3. Receives: Other: High intensity interval training |
| Hispanic | Experimental | Participants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3. Receives: Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline in VO2max at 3 weeks
Each participant performed VO2max testing on an electronically-braked cycle ergometer using a ramp protocol. During exercise, subjects expired through a plastic mouthpiece and low resistance valve into tubing connected to a mixing chamber. Measures of ventilation and expired fractions of oxygen and carbon dioxide were obtained throughout exercise by a metabolic cart. Gas exchange data including VO2, VCO2, and ventilation were time-averaged every 15 seconds. The test was terminated when the subject's pedal cadence was below 50 rev/min.
Measured: 3 weeks
Change in baseline in cardiac output max at 3 weeks
During the VO2max assessment, participants wore a thoracic impedance device to measure heart rate and stroke volume, calculating their cardiac output.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jun 2017
- Primary completion22 Dec 2019
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Improved VO2max and Cardiac Output in Response to TrainingStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study was a longitudinal, repeated measures between subjects design.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- California State University, San Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Todd A. Astorino Ph.D, California State University, San Marcos
- Investigators
- Todd Astorino, PhD, Principal investigator, California State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449016
- Sponsor's protocol ID
- 1200680-2
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raleigh JP, Giles MD, Scribbans TD, Edgett BA, Sawula LJ, Bonafiglia JT, Graham RB, Gurd BJ. The impact of work-matched interval training on V̇O2peak and V̇O2 kinetics: diminishing returns with increasing intensity. Appl Physiol Nutr Metab. 2016 Jul;41(7):706-13. doi: 10.1139/apnm-2015-0614. Epub 2016 Feb 29.
PubMed 27337599Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
PubMed 19199208Astorino TA, Schubert MM, Palumbo E, Stirling D, McMillan DW, Cooper C, Godinez J, Martinez D, Gallant R. Magnitude and time course of changes in maximal oxygen uptake in response to distinct regimens of chronic interval training in sedentary women. Eur J Appl Physiol. 2013 Sep;113(9):2361-9. doi: 10.1007/s00421-013-2672-1. Epub 2013 Jun 11.
PubMed 23754097Bowdon M, Marcovitz P, Jain SK, Boura J, Liroff KG, Franklin BA. Exercise Training in "At-Risk" Black and White Women: A Comparative Cohort Analyses. Med Sci Sports Exerc. 2018 Jul;50(7):1350-1356. doi: 10.1249/MSS.0000000000001580.
PubMed 29462100Gill JM, Celis-Morales CA, Ghouri N. Physical activity, ethnicity and cardio-metabolic health: does one size fit all? Atherosclerosis. 2014 Feb;232(2):319-33. doi: 10.1016/j.atherosclerosis.2013.11.039. Epub 2013 Nov 23.
PubMed 24468145Johnson JL, Slentz CA, Duscha BD, Samsa GP, McCartney JS, Houmard JA, Kraus WE. Gender and racial differences in lipoprotein subclass distributions: the STRRIDE study. Atherosclerosis. 2004 Oct;176(2):371-7. doi: 10.1016/j.atherosclerosis.2004.05.018.
PubMed 15380461Skinner JS, Jaskolski A, Jaskolska A, Krasnoff J, Gagnon J, Leon AS, Rao DC, Wilmore JH, Bouchard C; HERITAGE Family Study. Age, sex, race, initial fitness, and response to training: the HERITAGE Family Study. J Appl Physiol (1985). 2001 May;90(5):1770-6. doi: 10.1152/jappl.2001.90.5.1770.
PubMed 11299267
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training
- ClinicalTrials.gov ID
- NCT04449016
- Acronym / sponsor ID
- 1200680-2
- Keywords
- HIIT, Inactive, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- California State University, San MarcosUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 26 Jun 2020 (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.
The purpose of this study was to determine if ethnicity alters training responsiveness to a low dose of high intensity interval training in inactive women.
Detailed description
Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9 sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is well-tolerated in inactive individuals. Continuously during each session, heart rate was monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to training, as well as post.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a longitudinal, repeated measures between subjects design.
| Arm | Type | Receives |
|---|---|---|
| Caucasian | Experimental | Other: High intensity interval trainingParticipants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3. |
| Hispanic | Experimental | Other: High intensity interval trainingParticipants performed 9 sessions of HIIT over 3 weeks, utilizing progressive overload by increasing the number of bouts by 1 each week. They started with 8 bouts on week 1, 9 bouts on week 2, and 10 bouts on week 3. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women
- Between the age of 18-45
- Healthy and non-obese (BMI < 30 kg/m2)
- Perform less than 150 minutes per week of exercise in the last 12 months
- 100% Caucasian or 100% Hispanic
Key exclusion criteria (4 listed)
- Injured
- Obese
- Active
- Mixed ethnicity
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 |
|---|---|---|
| High intensity interval trainingRepeated, brief, and intense exercise bouts separated by active recovery | Other | Caucasian, Hispanic |
Primary outcome
Change in baseline in VO2max at 3 weeks
Time frame: 3 weeks
Each participant performed VO2max testing on an electronically-braked cycle ergometer using a ramp protocol. During exercise, subjects expired through a plastic mouthpiece and low resistance valve into tubing connected to a mixing chamber. Measures of ventilation and expired fractions of oxygen and carbon dioxide were obtained throughout exercise by a metabolic cart. Gas exchange data including VO2, VCO2, and ventilation were time-averaged every 15 seconds. The test was terminated when the subject's pedal cadence was below 50 rev/min.
Change in baseline in cardiac output max at 3 weeks
Time frame: 3 weeks
During the VO2max assessment, participants wore a thoracic impedance device to measure heart rate and stroke volume, calculating their cardiac output.
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 Jun 2020.
- Background: PubMed 27337599Raleigh JP, Giles MD, Scribbans TD, Edgett BA, Sawula LJ, Bonafiglia JT, Graham RB, Gurd BJ. The impact of work-matched interval training on V̇O2peak and V̇O2 kinetics: diminishing returns with increasing intensity. Appl Physiol Nutr Metab. 2016 Jul;41(7):706-13. doi: 10.1139/apnm-2015-0614. Epub 2016 Feb 29.
- Background: PubMed 19199208Astorino TA, White AC, Dalleck LC. Supramaximal testing to confirm attainment of VO2max in sedentary men and women. Int J Sports Med. 2009 Apr;30(4):279-84. doi: 10.1055/s-0028-1104588. Epub 2009 Feb 6.
- Background: PubMed 23754097Astorino TA, Schubert MM, Palumbo E, Stirling D, McMillan DW, Cooper C, Godinez J, Martinez D, Gallant R. Magnitude and time course of changes in maximal oxygen uptake in response to distinct regimens of chronic interval training in sedentary women. Eur J Appl Physiol. 2013 Sep;113(9):2361-9. doi: 10.1007/s00421-013-2672-1. Epub 2013 Jun 11.
- Background: PubMed 29462100Bowdon M, Marcovitz P, Jain SK, Boura J, Liroff KG, Franklin BA. Exercise Training in "At-Risk" Black and White Women: A Comparative Cohort Analyses. Med Sci Sports Exerc. 2018 Jul;50(7):1350-1356. doi: 10.1249/MSS.0000000000001580.
- Background: PubMed 24468145Gill JM, Celis-Morales CA, Ghouri N. Physical activity, ethnicity and cardio-metabolic health: does one size fit all? Atherosclerosis. 2014 Feb;232(2):319-33. doi: 10.1016/j.atherosclerosis.2013.11.039. Epub 2013 Nov 23.
- Background: PubMed 15380461Johnson JL, Slentz CA, Duscha BD, Samsa GP, McCartney JS, Houmard JA, Kraus WE. Gender and racial differences in lipoprotein subclass distributions: the STRRIDE study. Atherosclerosis. 2004 Oct;176(2):371-7. doi: 10.1016/j.atherosclerosis.2004.05.018.
- Background: PubMed 11299267Skinner JS, Jaskolski A, Jaskolska A, Krasnoff J, Gagnon J, Leon AS, Rao DC, Wilmore JH, Bouchard C; HERITAGE Family Study. Age, sex, race, initial fitness, and response to training: the HERITAGE Family Study. J Appl Physiol (1985). 2001 May;90(5):1770-6. doi: 10.1152/jappl.2001.90.5.1770.
- Individual participant dataSharing planned: Undecided
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.
Todd Astorino, PhD principal investigator
California State University, San Marcos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with Improved VO2max and Cardiac Output in Response to Training, run by California State University, San Marcos at 1 site in United States.
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 5 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 Jun 2020. 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 United States. 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?
Change in baseline in VO2max at 3 weeks (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT04449016, which also lists 7 linked publications.
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 Jun 2020.