High-Intensity Interval TrainingNCT05988606
Work Rate Adjustments During a High-intensity Interval Training on a Stationary Bike in a Hot and Temperate Environment
A study testing 15 minutes of high-intensity interval training, 43 minutes of high-intensity interval training and Hot environment in people with High-Intensity Interval Training and Heat, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
The goal of this repeated measures study is to evaluate acute work rate adjustments during high-intensity interval training (HIIT) in a hot and temperate environment in healthy and active adults when using target heart rate to prescribe the exercise intensity. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training, Heat
- What is being tested?
- 15 minutes of high-intensity interval training, 43 minutes of high-intensity interval training and Hot environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2021to 14 Nov 2021
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants were healthy males and females who are 18 to 39 years of age, recreationally active as defined by the American College of Sports Medicine, performing moderate-intensity aerobic exercise 30 min or more per session for at least 3 sessions per week for at least the past 3 months, and free of metabolic, cardiovascular, and renal disease
Who cannot join
- Individuals classified as needing medical clearance according to American College of Sports Medicine (ACSM) Guidelines were not allowed to participate. Needing medical clearance is defined by ACSM as 1) not being physically active and having known cardiovascular, metabolic, or renal disease and asymptomatic; 2) not being physically active and having any signs or symptoms suggestive of cardiovascular, metabolic, or renal disease; 3) participating in regular exercise and having known cardiovascular, metabolic, or renal disease and asymptomatic; or 4) participating in regular exercise and having any signs or symptoms suggestive of cardiovascular, metabolic, or renal disease .
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama
Tuscaloosa, Alabama, 35487
About this study
Official title: Acute Work Rate Adjustments During High-intensity Interval Training in a Hot and Temperate Environment
The goal of this repeated measures study is to evaluate acute work rate adjustments during high-intensity interval training (HIIT) in a hot and temperate environment in healthy and active adults when using target heart rate to prescribe the exercise intensity.
The main questions it aims to answer are:
Read more
- Will HIIT based on target heart rate in a hot environment result in increased cardiovascular (i.e., elevated recovery HR) and thermal strain compared to HIIT in a temperate environment?
- Will work rate be lowered to a greater extent during HIIT in a hot environment compared to a temperate environment in order to maintain target heart rate?
- Will maximal aerobic capacity (V̇O2max) decrease to a greater extent after HIIT in the heat compared to a temperate environment?
Procedures:
Participants will complete 5 trials on a cycle ergometer. Trial 1 (Control Visit): Participants (n = 7) will have their maximal heart rate and V̇O2max measured in a temperate environment (~22 °C, 40% RH).
Experimental Trials 2-5: The order of the trials will be counterbalanced and randomly assigned to participants.
- 15TEMP: Participants will cycle at 70% of their maximum heart rate for 8 minutes as a warm-up, followed by one round of HIIT. The HIIT protocol consists of 4 minutes at 90% of maximum heart rate followed by 3 minutes at 70% of maximum heart rate, totaling 15 minutes, in a temperate environment (~22 °C, 40% RH). After the HIIT session, a graded exercise test will measure V̇O2max.
- 15HEAT: Similar to 15TEMP, but participants will perform the HIIT protocol in a hot environment (~35 °C, 40% RH).
- 43TEMP: Participants will cycle at 70% of their maximum heart rate for 8 minutes as a warm-up, followed by the HIIT protocol repeated four times (4 minutes at 90% of maximum heart rate and 3 minutes at 70% of maximum heart rate), totaling 43 minutes, in a temperate environment (~22 °C, 40% RH).
- 43HEAT: Similar to 43TEMP, but participants will perform the HIIT protocol in a hot environment (~35 °C, 40% RH).
- Conditions
- High-Intensity Interval Training, Heat
- Being tested
- 15 minutes of high-intensity interval training, 43 minutes of high-intensity interval training, Hot environment, Temperate environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 minutes of high-intensity interval trainingBehavioural
Participants completed an 8 min warm-up and 1 round of high-intensity interval training
43 minutes of high-intensity interval trainingBehavioural
Participants completed an 8 min warm-up and 5 rounds of high-intensity interval training
Hot environmentOther
Participants exercised in a hot environment, ~ 35 °C, ~40% relative humidity.
Temperate environmentOther
Participants exercised in a temperate environment, ~ 22 °C, ~40% relative humidity.
| Study group | Role | What they receive |
|---|---|---|
| 15TEMP | Experimental | Participants cycled at 70% heart rate max for 8 min as a warm-up and then completed one round of HIIT, i.e., 4 min at 90% heart rate max followed by 3 min at 70% heart rate max for a total of 15 minutes in a temperate environment, followed by a graded exercise test to measure maximal aerobic capacity. Receives: Behavioral: 15 minutes of high-intensity interval training; Other: Temperate environment |
| 15HEAT | Experimental | Participants cycled at 70% heart rate max for 8 min as a warm-up and then completed one round of HIIT, i.e., 4 min at 90% heart rate max followed by 3 min at 70% heart rate max for a total of 15 minutes in a hot environment, followed by a graded exercise test to measure maximal aerobic capacity. Receives: Behavioral: 15 minutes of high-intensity interval training; Other: Hot environment |
| 43TEMP | Experimental | Participants cycled at 70% heart rate max for 8 min as a warm-up and then performed the HIIT protocol (4 min at 90% heart rate max and 3 min at 70% heart rate max, repeated 4 times for a total of 43 minutes) in a temperate environment followed by a graded exercise test to measure maximal aerobic capacity. Receives: Behavioral: 43 minutes of high-intensity interval training; Other: Temperate environment |
| 43HEAT | Experimental | Participants cycled at 70% heart rate max for 8 min as a warm-up and then performed the HIIT protocol (4 min at 90% heart rate max and 3 min at 70% heart rate max, repeated 4 times for a total of 43 minutes) in a hot environment followed by a graded exercise test to measure maximal aerobic capacity. Receives: Behavioral: 43 minutes of high-intensity interval training; Other: Hot environment |
| Control | No intervention | Participants completed a graded exercise test on a stationary bicycle in a temperate environment (~ 22 °C (72 °F), ~40% RH) to measure maximal aerobic capacity and maximal heart rate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work rate adjustments
In a hot and temperate environment by how much does work rate need to be adjusted to maintain target heart rate?
Measured: From the first work interval (min 9-12) to the last work interval (min 37-40).
Secondary outcomes (3)
Cardiovascular strain
In a hot and temperate environment by how much does heart rate in the recovery intervals increase?
Measured: From the first recovery interval (min 13-15) to the last recovery interval (min 41-43).
Thermal Strain
In a hot and temperate environment by how much do rectal temperature and skin temperature increase?
Measured: From the first work interval (min 9-12) to the last work interval (min 37-40).
Maximal aerobic capacity
In a hot and temperate environment by how much does maximal aerobic capacity decrease?
Measured: The end of the 15 min trials compared to the end of the 43 min trials.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 May 2021
- Primary completion14 Nov 2021
- Study completion14 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Intensity Interval 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants completed all trials and were compared to themselves.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988606
- Sponsor's protocol ID
- 21-02-4359
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Work Rate Adjustments During High-intensity Interval Training in a Hot and Temperate Environment
- ClinicalTrials.gov ID
- NCT05988606
- Acronym / sponsor ID
- 21-02-4359
- Conditions
- High-Intensity Interval Training, Heat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 14 Nov 2021 (actual)
- First posted
- 14 Aug 2023 (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 goal of this repeated measures study is to evaluate acute work rate adjustments during high-intensity interval training (HIIT) in a hot and temperate environment in healthy and active adults when using target heart rate to prescribe the exercise intensity.
The main questions it aims to answer are:
- Will HIIT based on target heart rate in a hot environment result in increased cardiovascular (i.e., elevated recovery HR) and thermal strain compared to HIIT in a temperate environment?
- Will work rate be lowered to a greater extent during HIIT in a hot environment compared to a temperate environment in order to maintain target heart rate?
- Will maximal aerobic capacity (V̇O2max) decrease to a greater extent after HIIT in the heat compared to a temperate environment?
Procedures:
Participants will complete 5 trials on a cycle ergometer. Trial 1 (Control Visit): Participants (n = 7) will have their maximal heart rate and V̇O2max measured in a temperate environment (~22 °C, 40% RH).
Experimental Trials 2-5: The order of the trials will be counterbalanced and randomly assigned to participants.
- 15TEMP: Participants will cycle at 70% of their maximum heart rate for 8 minutes as a warm-up, followed by one round of HIIT. The HIIT protocol consists of 4 minutes at 90% of maximum heart rate followed by 3 minutes at 70% of maximum heart rate, totaling 15 minutes, in a temperate environment (~22 °C, 40% RH). After the HIIT session, a graded exercise test will measure V̇O2max.
- 15HEAT: Similar to 15TEMP, but participants will perform the HIIT protocol in a hot environment (~35 °C, 40% RH).
- 43TEMP: Participants will cycle at 70% of their maximum heart rate for 8 minutes as a warm-up, followed by the HIIT protocol repeated four times (4 minutes at 90% of maximum heart rate and 3 minutes at 70% of maximum heart rate), totaling 43 minutes, in a temperate environment (~22 °C, 40% RH).
- 43HEAT: Similar to 43TEMP, but participants will perform the HIIT protocol in a hot environment (~35 °C, 40% RH).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Participants completed all trials and were compared to themselves.
| Arm | Type | Receives |
|---|---|---|
| 15TEMP | Experimental | Behavioral: 15 minutes of high-intensity interval training, Other: Temperate environmentParticipants cycled at 70% heart rate max for 8 min as a warm-up and then completed one round of HIIT, i.e., 4 min at 90% heart rate max followed by 3 min at 70% heart rate max for a total of 15 minutes in a temperate environment, followed by a graded exercise test to measure maximal aerobic capacity. |
| 15HEAT | Experimental | Behavioral: 15 minutes of high-intensity interval training, Other: Hot environmentParticipants cycled at 70% heart rate max for 8 min as a warm-up and then completed one round of HIIT, i.e., 4 min at 90% heart rate max followed by 3 min at 70% heart rate max for a total of 15 minutes in a hot environment, followed by a graded exercise test to measure maximal aerobic capacity. |
| 43TEMP | Experimental | Behavioral: 43 minutes of high-intensity interval training, Other: Temperate environmentParticipants cycled at 70% heart rate max for 8 min as a warm-up and then performed the HIIT protocol (4 min at 90% heart rate max and 3 min at 70% heart rate max, repeated 4 times for a total of 43 minutes) in a temperate environment followed by a graded exercise test to measure maximal aerobic capacity. |
| 43HEAT | Experimental | Behavioral: 43 minutes of high-intensity interval training, Other: Hot environmentParticipants cycled at 70% heart rate max for 8 min as a warm-up and then performed the HIIT protocol (4 min at 90% heart rate max and 3 min at 70% heart rate max, repeated 4 times for a total of 43 minutes) in a hot environment followed by a graded exercise test to measure maximal aerobic capacity. |
| Control | No intervention | –Participants completed a graded exercise test on a stationary bicycle in a temperate environment (~ 22 °C (72 °F), ~40% RH) to measure maximal aerobic capacity and maximal heart rate. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants were healthy males and females who are 18 to 39 years of age, recreationally active as defined by the American College of Sports Medicine, performing moderate-intensity aerobic exercise 30 min or more per session for at least 3 sessions per week for at least the past 3 months, and free of metabolic, cardiovascular, and renal disease
Key exclusion criteria (1 listed)
- Individuals classified as needing medical clearance according to American College of Sports Medicine (ACSM) Guidelines were not allowed to participate. Needing medical clearance is defined by ACSM as 1) not being physically active and having known cardiovascular, metabolic, or renal disease and asymptomatic; 2) not being physically active and having any signs or symptoms suggestive of cardiovascular, metabolic, or renal disease; 3) participating in regular exercise and having known cardiovascular, metabolic, or renal disease and asymptomatic; or 4) participating in regular exercise and having any signs or symptoms suggestive of cardiovascular, metabolic, or renal disease .
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 |
|---|---|---|
| 15 minutes of high-intensity interval trainingParticipants completed an 8 min warm-up and 1 round of high-intensity interval training | Behavioural | 15HEAT, 15TEMP |
| 43 minutes of high-intensity interval trainingParticipants completed an 8 min warm-up and 5 rounds of high-intensity interval training | Behavioural | 43HEAT, 43TEMP |
| Hot environmentParticipants exercised in a hot environment, ~ 35 °C, ~40% relative humidity. | Other | 15HEAT, 43HEAT |
| Temperate environmentParticipants exercised in a temperate environment, ~ 22 °C, ~40% relative humidity. | Other | 15TEMP, 43TEMP |
Primary outcome
Work rate adjustments
Time frame: From the first work interval (min 9-12) to the last work interval (min 37-40).
In a hot and temperate environment by how much does work rate need to be adjusted to maintain target heart rate?
3 secondary outcomes
Cardiovascular strain
Time frame: From the first recovery interval (min 13-15) to the last recovery interval (min 41-43).
Thermal Strain
Time frame: From the first work interval (min 9-12) to the last work interval (min 37-40).
Maximal aerobic capacity
Time frame: The end of the 15 min trials compared to the end of the 43 min trials.
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 14 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 minutes of high-intensity interval training, 43 minutes of high-intensity interval training and Hot environment in people with High-Intensity Interval Training and Heat, run by University of Alabama, Tuscaloosa 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 1 inclusion and 1 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 14 Aug 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 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?
Work rate adjustments (time frame: From the first work interval (min 9-12) to the last work interval (min 37-40).). 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 14 Aug 2023.