Physical ActivityNCT02164474
Small Steps for Big Changes
A study testing High-Intensity Interval Training in people with Physical Activity, run by University of British Columbia at 1 site in Canada.
Trial summary
Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard exercise program is dismal. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- 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
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Feb 2017
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 30-65
- Physically inactive (engaging in 2 or less aerobic exercise bouts per week in the last 6 months)
- BMI between 24-40 kg/m2
- Cleared to engage in vigorous exercise (via PARQ+ and, if advised by this validated tool further clearance by their family physician)
Who cannot join
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Failure to obtain medical clearance to engage in vigorous intensity exercise following a positive PARQ+ screening
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Diagnosed with type 2 diabetes
- Currently taking glucose-lowering medications (e.g., metformin), Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
- Change in cardiovascular medications (e.g., statins) in the previous 6 months Class III obesity (BMI >40 kg/m2).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health and Exercise Psychology Laboratory
Kelowna, British Columbia, V1V 1V7
About this study
Official title: Time-efficient High-intensity Interval Training Versus Moderate-intensity Continuous Aerobic Training for Promoting Exercise Adherence: A Randomized-controlled Trial
Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard exercise program is dismal. High-intensity interval training (HIIT) is a novel form of exercise that involves brief, repeated bursts of vigorous exercise separated by periods of recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to traditional exercise but does so with a lower amount of exercise and in substantially less time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a "time-efficient" exercise strategy for improving health. Whether overweight individuals at risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous exercise over the long-term (12-months) has not been tested. Because exercise adherence requires complex self-regulation, interventions designed to improve adherence should include a behavioural component. The investigators will assess adherence to HIIT and moderate-intensity continuous exercise over 12 months following a short-term (2 week) intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will include a self-regulatory component targeted to increase participants' confidence to engage in regular, independent exercise. The results will help determine whether HIIT is a more feasible option for promoting exercise adherence for pre diabetes prevention than the traditional moderate-intensity continuous exercise. The investigators hypothesize that a) over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up subjects randomized to HIIT will have higher rates of adherence and levels of total physical activity, c) greater increases in self-regulation (including goal setting, self-monitoring, and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d) 10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve glucose control and e) Improvements in cardiometabolic health factors will be greater following HIIT compared to moderate-intensity continuous exercise.
Read the detailed description
Eligible participants will be randomized to the HIIT or moderate-intensity continuous exercise conditions. Each condition will involve a two-week supervised exercise period consisting of ten sessions. Exercise prescriptions for each condition will be progressive in nature over the two week supervised period and will be matched for external work. Specifically, individuals randomized to HIIT will begin with four intervals lasting 1-minute each at ~85-90% peak oxygen uptake [VO2peak] and increased to 10 X 1-min intervals by day 10. Individuals randomized to moderate-intensity exercise condition will begin with 20 minutes of continuous activity at ~55-60% V02peak and gradually increase the duration to 50 minutes by day 10. Participants will self-select exercise modality (walking outdoors, elliptical machine, treadmill walking, or stationary cycling). One trainer will supervise participants during the 2-week training program. Participants will complete 3 of the 10 training days (day 4, 7 and 9) at home unsupervised. Participants will wear a heart rate monitor during each exercise session (supervised and unsupervised) to monitor exercise intensity and ensure compliance. In addition, participants will record their exercise bouts in a logbook on both lab and home training days.
Participants in both conditions received 10 minutes of behavioural counseling each day they trained in the lab (for a total of 70 minutes). Following the supervised training, participants will be instructed to maintain HIIT or moderate-intensity continuous exercise three days per week independently. Specifically, individuals randomized to HIIT will be prescribed three exercise sessions per week involving 10 X 1-minute intervals at ~85-90% VO2peak, while participants randomized to moderate-intensity continuous exercise will be prescribed three session per week of 50-minute continuous exercise at ~55-60% VO2peak. Training logs will be provided and participants will be instructed to estimate exercise intensity based on physiological cues taught during supervised training days.
- Conditions
- Physical Activity
- Being tested
- High-Intensity Interval Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval TrainingBehavioural
Specifically, individuals randomized to HIIT will begin the intervention with four intervals lasting 1-minute each at ~85-90% peak oxygen uptake [VO2peak] and increasing to 10 X 1-min intervals by day 10 of the intervention. Individuals randomized to moderate-intensity exercise condition will begin the intervention with 20 minutes of continuous activity at ~55-60% V02peak and gradually increase the duration to 50 minutes by day 10 of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Participants will perform a series of high-intensity intervals with an interval length of 60-seconds at 90% of peak aerobic capacity workload, and a rest length of 60-seconds. Receives: Behavioral: High-Intensity Interval Training |
| Moderate-Intensity Continuous Exercise | Active comparator | Participants will engage in exercise at 45% of peak aerobic capacity workload. Receives: Behavioral: High-Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cardiorespiratory fitness (VO2peak) at 6 and 12-month follow-up
Changes in cardiorespiratory fitness (VO2peak), an objective measure of fitness and habitual activity, will be used as an integrative measure of exercise adherence (and overall health) at 6-month and 12-month follow-up. Specifically, peak oxygen uptake (VO2peak) will be assessed by a maximal cycling exercise test. Power output will begin at 30 W and increase by 15 W/min until volitional exhaustion. Expired gas samples will be collected continuously and VO2 measured by a metabolic cart (Parvomedics TrueOne 2400). The mean of the two highest 30 s average values will define VO2peak. VO2peak will be confirmed using standard criteria110. A Polar chest strap, which is integrated to the metabolic cart and cycle ergometer (Lode Excalibur), will capture Heart Rate. Peak power output will be recorded as the highest value attained.
Measured: Baseline, 6-month follow-up and 12-month follow-up
Secondary outcomes (4)
Self reported adherence to exercise prescription
Self-reported adherence will be measuring using an online exercise log book, which participants will be asked to fill in following each exercise session. Adherence will be measured using raw exercise prescription bouts completed. Proportion achieved based on the amount prescription will also be calculated.
Measured: Exercise log book filled in for a 12-month duration
Changes from baseline in objectively measured moderate-to-vigorous physical activity in bouts ≥10 minutes (MVPA10+) at 3-, 6-, 9-, and 12-months follow-up
Changes in total time spent in moderate-to-vigorous physical activity in bouts ≥10 minutes (MVPA10+) will be assessed over 7 days using tri-axial accelerometers at baseline and 3, 6-, 9- and 12-month follow-up.
Measured: Baseline, 3-, 6-, 9-, 12-month follow-up
Changes in efficacy beliefs
Changes in participants exercise efficacy beliefs, self-regulatory efficacy beliefs, concurrent self-regulatory efficacy beliefs, and self-monitoring efficacy beliefs will be measured at baseline, post-intervention, 6-month follow-up and 12-month follow-up. Efficacy measures will be context specific and will utilize a confidence scale ranging from 0%-100%.
Measured: Baseline, Post-Intervention, 6-, 12-month follow-up
Changes in body composition
Body composition will be assessed using the Hologic Discovery A device. DXA is a standard tool in the measurement of body composition and bone density in adults and children throughout multiple institutions.
Measured: Baseline, post Intervention, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mary E Jung, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164474
- Sponsor's protocol ID
- H12-02268
- Status last verified
- Mar 2017
- First submitted
- 12 Jun 2014
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Little JP, Safdar A, Wilkin GP, Tarnopolsky MA, Gibala MJ. A practical model of low-volume high-intensity interval training induces mitochondrial biogenesis in human skeletal muscle: potential mechanisms. J Physiol. 2010 Mar 15;588(Pt 6):1011-22. doi: 10.1113/jphysiol.2009.181743. Epub 2010 Jan 25.
PubMed 20100740Little JP, Gillen JB, Percival ME, Safdar A, Tarnopolsky MA, Punthakee Z, Jung ME, Gibala MJ. Low-volume high-intensity interval training reduces hyperglycemia and increases muscle mitochondrial capacity in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Dec;111(6):1554-60. doi: 10.1152/japplphysiol.00921.2011. Epub 2011 Aug 25.
PubMed 21868679Hood MS, Little JP, Tarnopolsky MA, Myslik F, Gibala MJ. Low-volume interval training improves muscle oxidative capacity in sedentary adults. Med Sci Sports Exerc. 2011 Oct;43(10):1849-56. doi: 10.1249/MSS.0b013e3182199834.
PubMed 21448086Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.
PubMed 12471307Jung ME, Wright WL, Wright AE, Ainslie PN, Little JP. Does the Relationship Between Affect and Exercise Intensity Apply to High-Intensity Interval Exercise? Medicine & Science in Sports & Exercise. 2012;44(5S):85.
Bourne JE, Little JP, Beauchamp MR, Barry J, Singer J, Jung ME. Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Mar 26;8(3):e11226. doi: 10.2196/11226.
PubMed 30912761Bourne JE, Ivanova E, Gainforth HL, Jung ME. Mapping behavior change techniques to characterize a social cognitive theory informed physical activity intervention for adults at risk of type 2 diabetes mellitus. Transl Behav Med. 2020 Aug 7;10(3):705-715. doi: 10.1093/tbm/ibz008.
PubMed 30715534Barry JC, Simtchouk S, Durrer C, Jung ME, Mui AL, Little JP. Short-term exercise training reduces anti-inflammatory action of interleukin-10 in adults with obesity. Cytokine. 2018 Nov;111:460-469. doi: 10.1016/j.cyto.2018.05.035. Epub 2018 Jun 6.
PubMed 29885989
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-efficient High-intensity Interval Training Versus Moderate-intensity Continuous Aerobic Training for Promoting Exercise Adherence: A Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02164474
- Acronym / sponsor ID
- H12-02268
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Jun 2014 (estimated)
- 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.
Exercise is a proven strategy for preventing type 2 diabetes. Traditionally individuals have been prescribed moderate-intensity continuous aerobic exercise but adherence to this standard exercise program is dismal. High-intensity interval training (HIIT) is a novel form of exercise that involves brief, repeated bursts of vigorous exercise separated by periods of recovery. HIIT elicits many favourable cardiometabolic adaptations that are similar to traditional exercise but does so with a lower amount of exercise and in substantially less time than moderate-intensity continuous exercise. Therefore, HIIT has been touted as a "time-efficient" exercise strategy for improving health. Whether overweight individuals at risk for pre diabetes will show greater adherence to HIIT than moderate-intensity continuous exercise over the long-term (12-months) has not been tested. Because exercise adherence requires complex self-regulation, interventions designed to improve adherence should include a behavioural component. The investigators will assess adherence to HIIT and moderate-intensity continuous exercise over 12 months following a short-term (2 week) intervention of either HIIT or moderate-intensity continuous exercise. Both conditions will include a self-regulatory component targeted to increase participants' confidence to engage in regular, independent exercise. The results will help determine whether HIIT is a more feasible option for promoting exercise adherence for pre diabetes prevention than the traditional moderate-intensity continuous exercise. The investigators hypothesize that a) over the 12 months follow-up subjects randomized to the HIIT will be more likely to adhere when compared to moderate-intensity continuous exercise, b) over the 12 months follow-up subjects randomized to HIIT will have higher rates of adherence and levels of total physical activity, c) greater increases in self-regulation (including goal setting, self-monitoring, and self-regulatory efficacy) following HIIT will mediate higher rates of adherence, d) 10-days of HIIT and moderate-intensity continuous exercise will improve cardiorespiratory fitness, increase insulin sensitivity, reduce circulating inflammatory markers, and improve glucose control and e) Improvements in cardiometabolic health factors will be greater following HIIT compared to moderate-intensity continuous exercise.
Detailed description
Eligible participants will be randomized to the HIIT or moderate-intensity continuous exercise conditions. Each condition will involve a two-week supervised exercise period consisting of ten sessions. Exercise prescriptions for each condition will be progressive in nature over the two week supervised period and will be matched for external work. Specifically, individuals randomized to HIIT will begin with four intervals lasting 1-minute each at ~85-90% peak oxygen uptake [VO2peak] and increased to 10 X 1-min intervals by day 10. Individuals randomized to moderate-intensity exercise condition will begin with 20 minutes of continuous activity at ~55-60% V02peak and gradually increase the duration to 50 minutes by day 10. Participants will self-select exercise modality (walking outdoors, elliptical machine, treadmill walking, or stationary cycling). One trainer will supervise participants during the 2-week training program. Participants will complete 3 of the 10 training days (day 4, 7 and 9) at home unsupervised. Participants will wear a heart rate monitor during each exercise session (supervised and unsupervised) to monitor exercise intensity and ensure compliance. In addition, participants will record their exercise bouts in a logbook on both lab and home training days.
Participants in both conditions received 10 minutes of behavioural counseling each day they trained in the lab (for a total of 70 minutes). Following the supervised training, participants will be instructed to maintain HIIT or moderate-intensity continuous exercise three days per week independently. Specifically, individuals randomized to HIIT will be prescribed three exercise sessions per week involving 10 X 1-minute intervals at ~85-90% VO2peak, while participants randomized to moderate-intensity continuous exercise will be prescribed three session per week of 50-minute continuous exercise at ~55-60% VO2peak. Training logs will be provided and participants will be instructed to estimate exercise intensity based on physiological cues taught during supervised training days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) | Experimental | Behavioral: High-Intensity Interval TrainingParticipants will perform a series of high-intensity intervals with an interval length of 60-seconds at 90% of peak aerobic capacity workload, and a rest length of 60-seconds. |
| Moderate-Intensity Continuous Exercise | Active comparator | Behavioral: High-Intensity Interval TrainingParticipants will engage in exercise at 45% of peak aerobic capacity workload. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 30-65
- Physically inactive (engaging in 2 or less aerobic exercise bouts per week in the last 6 months)
- BMI between 24-40 kg/m2
- Cleared to engage in vigorous exercise (via PARQ+ and, if advised by this validated tool further clearance by their family physician)
Key exclusion criteria (6 listed)
- Any contraindications to exercise (e.g., musculoskeletal injury)
- Failure to obtain medical clearance to engage in vigorous intensity exercise following a positive PARQ+ screening
- Prior history of cardio- or cerebrovascular disease or myocardial infarction
- Diagnosed with type 2 diabetes
- Currently taking glucose-lowering medications (e.g., metformin), Hypertension that is not controlled by medication (systolic blood pressure (BP) >160 mmHg and/or diastolic BP >99 mmHg)
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 TrainingSpecifically, individuals randomized to HIIT will begin the intervention with four intervals lasting 1-minute each at ~85-90% peak oxygen uptake [VO2peak] and increasing to 10 X 1-min intervals by day 10 of the intervention. Individuals randomized to moderate-intensity exercise condition will begin the intervention with 20 minutes of continuous activity at ~55-60% V02peak and gradually increase the duration to 50 minutes by day 10 of the intervention. | Behavioural | High-Intensity Interval Training (HIIT), Moderate-Intensity Continuous Exercise |
Primary outcome
Change from baseline in cardiorespiratory fitness (VO2peak) at 6 and 12-month follow-up
Time frame: Baseline, 6-month follow-up and 12-month follow-up
Changes in cardiorespiratory fitness (VO2peak), an objective measure of fitness and habitual activity, will be used as an integrative measure of exercise adherence (and overall health) at 6-month and 12-month follow-up. Specifically, peak oxygen uptake (VO2peak) will be assessed by a maximal cycling exercise test. Power output will begin at 30 W and increase by 15 W/min until volitional exhaustion. Expired gas samples will be collected continuously and VO2 measured by a metabolic cart (Parvomedics TrueOne 2400). The mean of the two highest 30 s average values will define VO2peak. VO2peak will be confirmed using standard criteria110. A Polar chest strap, which is integrated to the metabolic cart and cycle ergometer (Lode Excalibur), will capture Heart Rate. Peak power output will be recorded as the highest value attained.
4 secondary outcomes
Self reported adherence to exercise prescription
Time frame: Exercise log book filled in for a 12-month duration
Changes from baseline in objectively measured moderate-to-vigorous physical activity in bouts ≥10 minutes (MVPA10+) at 3-, 6-, 9-, and 12-months follow-up
Time frame: Baseline, 3-, 6-, 9-, 12-month follow-up
Changes in efficacy beliefs
Time frame: Baseline, Post-Intervention, 6-, 12-month follow-up
Changes in body composition
Time frame: Baseline, post Intervention, 12-month follow-up
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 16 Mar 2017.
- Background: PubMed 20100740Little JP, Safdar A, Wilkin GP, Tarnopolsky MA, Gibala MJ. A practical model of low-volume high-intensity interval training induces mitochondrial biogenesis in human skeletal muscle: potential mechanisms. J Physiol. 2010 Mar 15;588(Pt 6):1011-22. doi: 10.1113/jphysiol.2009.181743. Epub 2010 Jan 25.
- Background: PubMed 21868679Little JP, Gillen JB, Percival ME, Safdar A, Tarnopolsky MA, Punthakee Z, Jung ME, Gibala MJ. Low-volume high-intensity interval training reduces hyperglycemia and increases muscle mitochondrial capacity in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Dec;111(6):1554-60. doi: 10.1152/japplphysiol.00921.2011. Epub 2011 Aug 25.
- Background: PubMed 21448086Hood MS, Little JP, Tarnopolsky MA, Myslik F, Gibala MJ. Low-volume interval training improves muscle oxidative capacity in sedentary adults. Med Sci Sports Exerc. 2011 Oct;43(10):1849-56. doi: 10.1249/MSS.0b013e3182199834.
- Background: PubMed 12471307Trost SG, Owen N, Bauman AE, Sallis JF, Brown W. Correlates of adults' participation in physical activity: review and update. Med Sci Sports Exerc. 2002 Dec;34(12):1996-2001. doi: 10.1097/00005768-200212000-00020.
- BackgroundJung ME, Wright WL, Wright AE, Ainslie PN, Little JP. Does the Relationship Between Affect and Exercise Intensity Apply to High-Intensity Interval Exercise? Medicine & Science in Sports & Exercise. 2012;44(5S):85.
- Derived from this study: PubMed 30912761Bourne JE, Little JP, Beauchamp MR, Barry J, Singer J, Jung ME. Brief Exercise Counseling and High-Intensity Interval Training on Physical Activity Adherence and Cardiometabolic Health in Individuals at Risk of Type 2 Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Mar 26;8(3):e11226. doi: 10.2196/11226.
- Derived from this study: PubMed 30715534Bourne JE, Ivanova E, Gainforth HL, Jung ME. Mapping behavior change techniques to characterize a social cognitive theory informed physical activity intervention for adults at risk of type 2 diabetes mellitus. Transl Behav Med. 2020 Aug 7;10(3):705-715. doi: 10.1093/tbm/ibz008.
- Derived from this study: PubMed 29885989Barry JC, Simtchouk S, Durrer C, Jung ME, Mui AL, Little JP. Short-term exercise training reduces anti-inflammatory action of interleukin-10 in adults with obesity. Cytokine. 2018 Nov;111:460-469. doi: 10.1016/j.cyto.2018.05.035. Epub 2018 Jun 6.
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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.
Mary E Jung, PhD principal investigator
University of British Columbia
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 Physical Activity, run by University of British Columbia 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 4 inclusion and 6 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 16 Mar 2017. 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?
Change from baseline in cardiorespiratory fitness (VO2peak) at 6 and 12-month follow-up (time frame: Baseline, 6-month follow-up and 12-month follow-up). 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 NCT02164474, which also lists 8 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 16 Mar 2017.