Apparently Healthy Adults Cycling PerformanceVPHIITNCT04999410
Virtual Programming Interval Training for TT Performance
A study testing High Intensity Interval Training in people with Apparently Healthy Adults Cycling Performance, run by Scott G. Thomas at 1 site in Canada.
Trial summary
High Intensity Interval Training (HIIT) studies are required to determine the optimal training protocol to improve time trial(TT) performance. Data collection for this study will be conducted virtually through the use of a software platform (www.trainerroad.com) by people in their homes on cycle ergometers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Apparently Healthy Adults Cycling Performance
- What is being tested?
- High Intensity Interval Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2020to 31 Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18 and 45 years of age
- cycling for a minimum of 3 times per week for the previous 6-months.
Who cannot join
- an injury in the previous 6-months preventing them from completing their normal training routine
- presence of pathology including cardiovascular diseases (heart attack, hypertension), neurological conditions (stroke, etc.) or metabolic conditions (diabetes).
- Participants will be asked to confirm their health status when they complete the intake survey.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Goldring High Performance Sport Centre
Toronto, Ontario, M5S2W6
Scott Thomas, 6475196957, scott.thomas@utoronto.ca
Michael Rosenblat, PhD (Cand), 778-782-9084, m.rosenblat@mail.utoronto.ca
About this study
Official title: Programming Interval Training Based on the HIIT Classification System on Time-Trial Performance v2
High Intensity Interval Training (HIIT) studies are required to determine the optimal training protocol to improve time trial(TT) performance. Data collection for this study will be conducted virtually through the use of a software platform (www.trainerroad.com) by people in their homes on cycle ergometers. Investigators will recruit people who are familiar with cycle exercise training and have their own equipment. By using a virtual platform to collect data, investigators will extend our reach to include a much larger and diverse sample of adult men and women up to age 45 years. In addition, the software platform will allow participants to train from the safety of their home, preventing the risk of exposure to COVID19.
OBJECTIVES O1: The primary objective of this study is to determine the influence of interval work-bout duration on TT performance when total mechanical work is matched.
Read more
O2: The secondary objective of the study is to determine the influence of work-bout duration on TT performance when work is matched by effort.
HYPOTHESIS H1: long duration bouts of HIIT will lead to greater improvements in performance compared to short duration bouts due to larger total amount of work completed during the interval sessions.
H2: HIIT will lead to equivalent improvements in performance when work is matched by the participant's rating of effort.
Read the detailed description
Participants will complete a training history and will be characterized with a questionnaire with respect to age, sex and location. Prior to the first testing session, participants will keep a food diary for the day preceeding the testing session to permit replication of diet for other testing weeks. Participants will be provided with a coded TrainerRoad account used to record all testing and training data. Training sessions will be pre-programmed into the TrainerRoad platform. All testing and training will be completed by participants at their residence on their own bicycles with the use of a smart trainer. Participants will complete an incremental exercise test (IET) to determine their maximal power output (Wmax) and two 40-minute Time Trials (TTs). The IET includes a warmup followed by ramp increases in intensity to a voluntary maximum; typically reached after 8 to 12 min.
Testing will be conducted in the 2-weeks prior and the week following the intervention. Once baseline testing is completed, participants will begin the interval training program which will consist of two interval training sessions per week and 2-3 sessions of low-intensity continuous training. There will be assessor blinding since all testing and training will be conducted solely by the participant with guidance from the TrainerRoad software.
MEASUREMENTS Time-Trial Performance The TT test will be performed by each participant on their own bicycle connected to a smart trainer. Following the warmup, participants will complete a 40-minute TT to determine their maximal sustainable power which corresponds to 7-8/10 on the 10 point Borg RPE scale. For the first TT test, participants will set their workload to 65% of the power achieved from the IET. Participants can consume water ad libitum for the duration of the time trial. Heart rate, cadence, mean power output and maximal power output will be recorded using the TrainerRoad platform.
Maximal Power Output (Wmax). The incremental exercise test determines Wmax. The first stage of the assessment will be completed at the same intensity completed during the warmup phase and increased by 12.5 watts every 30-seconds until the participant is unable to maintain a cadence of 70 RPM. All data will be collected using the TrainerRoad platform.
INTERVENTIONS Participants will be randomly allocated to one of four interval training groups via a computer-generated random sequence. Randomization and allocation will be concealed from the investigators. The groups will consist of a long-HIIT, a medium-HIIT matched to long work, a medium-HIIT that is performed at 15% higher intensity (Medium-HIIT-H), and intermittent short-HIIT (Short-HIIT). Each participant will be aware that they will be completing one of four interval exercise programs, however, they will be blinded to the details of the other programs.
Interval Exercise. Participants will perform a 15-minute warm-up. Following the interval session, they will complete a 10-minute cool down. Interval exercise intensity and durations will be provided through the TrainerRoad program.
Long-HIIT will include 4-repetitions of 6-minute work-bouts with 4-minutes of recovery between bouts. The intensity will be set to 15% of the difference between Wmax and the mean power achieved in the 40-minute TT test.
Medium-HIIT will consist of 12-repetitions of 2-minute work-bouts with 2-minutes of recovery. The Medium-HIIT-L group will exercise at the same intensity as the long-HIIT group whereas the Medium-HIIT-H group will perform the interval sessions at 30% of the difference between Wmax and the mean power achieved in the 40-minute TT test. During recovery-bouts, participants cycle at 40% of the work-bout intensity. Short-HIIT will consist of three sets of 16-repetitions of 30-second work-bouts with 15-seconds of active recovery at 50% of the work-intensity with 4-minutes of active recovery.
Low-Intensity Continuous Training (LICT). In addition to the interval training, participants perform at least 3 sessions of low-intensity continuous training (LICT) for 60-minutes to simulate a polarized training model. The intensity for LICT will be set to 40% of the interval training session power. A polarized training model leads to greater improvements in endurance performance when compared to a threshold training or interval training alone.
DATA COLLECTION All participants will be provided with a coded TrainerRoad account to record all testing and training data. Training sessions will be pre-programmed into the TrainerRoad platform. All testing and training will be completed by participants at their residence on their own bicycles with the use of a smart trainer. The TrainerRoad application will record power output, heart rate and cadence for the duration of each exercise session. At the end of each session, participants will record their session rating of perceived exertion on TrainerRoad.
STATISTICAL ANALYSIS Data analysis will be conducted using R and R-Studio. A comparison of the mean of the performance variables will be assessed using a repeated-measures analysis of the variance (ANOVA) to determine differences between the interval protocols. The primary outcome is change in time-trial mean power. Secondary outcomes include change in maximal power output (Wmax), session rating of perceived exertion, time-trial perceived exertion, and adherence. A subgroup analysis will be conducted from baseline data including age, sex, baseline TT performance and Wmax/kg. If there is a significant difference, a post-hoc analysis will be completed using a paired Student's t-test with Bonferroni correction. The level of significance will be set to a p-value of 0.05. Effect size calculations (Cohen's d) with 95% confidence intervals will be used to determine the magnitude of the effect.
- Being tested
- High Intensity Interval Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
Interventions will contrast alternative training protocols
| Study group | Role | What they receive |
|---|---|---|
| Long-HITT | Experimental | Long work bout durations (4 minutes) on cycle ergometers or home trainers Receives: Behavioral: High Intensity Interval Training |
| Medium HIIT-L | Active comparator | Medium duration work bouts (2 minutes) with intensity matched to the Long-HITT intensity Receives: Behavioral: High Intensity Interval Training |
| Medium HIIT-H | Active comparator | Medium duration work bouts (2 minutes) with intensity at 30% of the difference between Wmax and mean TT power outputs Receives: Behavioral: High Intensity Interval Training |
| Short HIIT | Active comparator | Short duration work bouts (30 seconds) with intensity at 50% of the difference between Wmax and mean TT power outputs Receives: Behavioral: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Trial Performance
Change in Time required to complete a 40 kilometer simulated cycle ride
Measured: 1 week before and 1 to 3 days after interventions
Secondary outcomes (1)
Peak Power Output
Change in Maximum power output (Watts) achieved on a incremental cycle test
Measured: Before and 1 to 3 days after interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start20 Nov 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apparently Healthy Adults Cycling PerformanceStudies 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
- Parallel groups
- Model description
- Participants will be randomly assigned to one of four training intervention groups. Before to after changes will be contrasted.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott G. Thomas
- Sponsor type
- University, hospital or other
- Collaborators
- TrainerRoad (see TrainerRoad.com)
- Responsible party
- Sponsor-investigator, Scott G. Thomas, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999410
- Sponsor's protocol ID
- VirtualHIITProgramming01
- Acronym
- VPHIIT
- Status last verified
- Aug 2021
- First submitted
- 29 Nov 2020
- Last updated
- 10 Aug 2021
- 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 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming Interval Training Based on the HIIT Classification System on Time-Trial Performance v2
- ClinicalTrials.gov ID
- NCT04999410
- Acronym / sponsor ID
- VPHIIT / VirtualHIITProgramming01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Scott G. ThomasUniversity, hospital or other
- Collaborators
- TrainerRoad (see TrainerRoad.com)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 10 Aug 2021 (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.
High Intensity Interval Training (HIIT) studies are required to determine the optimal training protocol to improve time trial(TT) performance. Data collection for this study will be conducted virtually through the use of a software platform (www.trainerroad.com) by people in their homes on cycle ergometers. Investigators will recruit people who are familiar with cycle exercise training and have their own equipment. By using a virtual platform to collect data, investigators will extend our reach to include a much larger and diverse sample of adult men and women up to age 45 years. In addition, the software platform will allow participants to train from the safety of their home, preventing the risk of exposure to COVID19.
OBJECTIVES O1: The primary objective of this study is to determine the influence of interval work-bout duration on TT performance when total mechanical work is matched.
O2: The secondary objective of the study is to determine the influence of work-bout duration on TT performance when work is matched by effort.
HYPOTHESIS H1: long duration bouts of HIIT will lead to greater improvements in performance compared to short duration bouts due to larger total amount of work completed during the interval sessions.
H2: HIIT will lead to equivalent improvements in performance when work is matched by the participant's rating of effort.
Detailed description
Participants will complete a training history and will be characterized with a questionnaire with respect to age, sex and location. Prior to the first testing session, participants will keep a food diary for the day preceeding the testing session to permit replication of diet for other testing weeks. Participants will be provided with a coded TrainerRoad account used to record all testing and training data. Training sessions will be pre-programmed into the TrainerRoad platform. All testing and training will be completed by participants at their residence on their own bicycles with the use of a smart trainer. Participants will complete an incremental exercise test (IET) to determine their maximal power output (Wmax) and two 40-minute Time Trials (TTs). The IET includes a warmup followed by ramp increases in intensity to a voluntary maximum; typically reached after 8 to 12 min.
Testing will be conducted in the 2-weeks prior and the week following the intervention. Once baseline testing is completed, participants will begin the interval training program which will consist of two interval training sessions per week and 2-3 sessions of low-intensity continuous training. There will be assessor blinding since all testing and training will be conducted solely by the participant with guidance from the TrainerRoad software.
MEASUREMENTS Time-Trial Performance The TT test will be performed by each participant on their own bicycle connected to a smart trainer. Following the warmup, participants will complete a 40-minute TT to determine their maximal sustainable power which corresponds to 7-8/10 on the 10 point Borg RPE scale. For the first TT test, participants will set their workload to 65% of the power achieved from the IET. Participants can consume water ad libitum for the duration of the time trial. Heart rate, cadence, mean power output and maximal power output will be recorded using the TrainerRoad platform.
Maximal Power Output (Wmax). The incremental exercise test determines Wmax. The first stage of the assessment will be completed at the same intensity completed during the warmup phase and increased by 12.5 watts every 30-seconds until the participant is unable to maintain a cadence of 70 RPM. All data will be collected using the TrainerRoad platform.
INTERVENTIONS Participants will be randomly allocated to one of four interval training groups via a computer-generated random sequence. Randomization and allocation will be concealed from the investigators. The groups will consist of a long-HIIT, a medium-HIIT matched to long work, a medium-HIIT that is performed at 15% higher intensity (Medium-HIIT-H), and intermittent short-HIIT (Short-HIIT). Each participant will be aware that they will be completing one of four interval exercise programs, however, they will be blinded to the details of the other programs.
Interval Exercise. Participants will perform a 15-minute warm-up. Following the interval session, they will complete a 10-minute cool down. Interval exercise intensity and durations will be provided through the TrainerRoad program.
Long-HIIT will include 4-repetitions of 6-minute work-bouts with 4-minutes of recovery between bouts. The intensity will be set to 15% of the difference between Wmax and the mean power achieved in the 40-minute TT test.
Medium-HIIT will consist of 12-repetitions of 2-minute work-bouts with 2-minutes of recovery. The Medium-HIIT-L group will exercise at the same intensity as the long-HIIT group whereas the Medium-HIIT-H group will perform the interval sessions at 30% of the difference between Wmax and the mean power achieved in the 40-minute TT test. During recovery-bouts, participants cycle at 40% of the work-bout intensity. Short-HIIT will consist of three sets of 16-repetitions of 30-second work-bouts with 15-seconds of active recovery at 50% of the work-intensity with 4-minutes of active recovery.
Low-Intensity Continuous Training (LICT). In addition to the interval training, participants perform at least 3 sessions of low-intensity continuous training (LICT) for 60-minutes to simulate a polarized training model. The intensity for LICT will be set to 40% of the interval training session power. A polarized training model leads to greater improvements in endurance performance when compared to a threshold training or interval training alone.
DATA COLLECTION All participants will be provided with a coded TrainerRoad account to record all testing and training data. Training sessions will be pre-programmed into the TrainerRoad platform. All testing and training will be completed by participants at their residence on their own bicycles with the use of a smart trainer. The TrainerRoad application will record power output, heart rate and cadence for the duration of each exercise session. At the end of each session, participants will record their session rating of perceived exertion on TrainerRoad.
STATISTICAL ANALYSIS Data analysis will be conducted using R and R-Studio. A comparison of the mean of the performance variables will be assessed using a repeated-measures analysis of the variance (ANOVA) to determine differences between the interval protocols. The primary outcome is change in time-trial mean power. Secondary outcomes include change in maximal power output (Wmax), session rating of perceived exertion, time-trial perceived exertion, and adherence. A subgroup analysis will be conducted from baseline data including age, sex, baseline TT performance and Wmax/kg. If there is a significant difference, a post-hoc analysis will be completed using a paired Student's t-test with Bonferroni correction. The level of significance will be set to a p-value of 0.05. Effect size calculations (Cohen's d) with 95% confidence intervals will be used to determine the magnitude of the effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned to one of four training intervention groups. Before to after changes will be contrasted.
| Arm | Type | Receives |
|---|---|---|
| Long-HITT | Experimental | Behavioral: High Intensity Interval TrainingLong work bout durations (4 minutes) on cycle ergometers or home trainers |
| Medium HIIT-L | Active comparator | Behavioral: High Intensity Interval TrainingMedium duration work bouts (2 minutes) with intensity matched to the Long-HITT intensity |
| Medium HIIT-H | Active comparator | Behavioral: High Intensity Interval TrainingMedium duration work bouts (2 minutes) with intensity at 30% of the difference between Wmax and mean TT power outputs |
| Short HIIT | Active comparator | Behavioral: High Intensity Interval TrainingShort duration work bouts (30 seconds) with intensity at 50% of the difference between Wmax and mean TT power outputs |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- between the ages of 18 and 45 years of age
- cycling for a minimum of 3 times per week for the previous 6-months.
Key exclusion criteria (3 listed)
- an injury in the previous 6-months preventing them from completing their normal training routine
- presence of pathology including cardiovascular diseases (heart attack, hypertension), neurological conditions (stroke, etc.) or metabolic conditions (diabetes).
- Participants will be asked to confirm their health status when they complete the intake survey.
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 TrainingInterventions will contrast alternative training protocols | Behavioural | Long-HITT, Medium HIIT-H, Medium HIIT-L, Short HIIT |
Primary outcome
Time Trial Performance
Time frame: 1 week before and 1 to 3 days after interventions
Change in Time required to complete a 40 kilometer simulated cycle ride
1 secondary outcome
Peak Power Output
Time frame: Before and 1 to 3 days after interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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.
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 Apparently Healthy Adults Cycling Performance, run by Scott G. Thomas 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott G Thomas, PhD (6475196957, scott.thomas@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Trial Performance (time frame: 1 week before and 1 to 3 days after interventions). 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 10 Aug 2021.