High Intensity Interval TrainingNCT03700671
High Intensity Interval Training Versus Circuit Training
A study testing High intensity interval training and Circuit training in people with High Intensity Interval Training, run by University of Central Lancashire at 1 site in United Kingdom.
Trial summary
High intensity interval training (HIIT) and circuit training (CT) are popular methods of exercise, eliciting improvements in cardiorespiratory fitness (CRF). However direct comparisons of these two training methods are limited. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- High Intensity Interval Training
- What is being tested?
- High intensity interval training and Circuit training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 May 2016to 13 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants reported no medical history of cardiometabolic or limiting respiratory disease, were non-smokers, had a body mass index <30 kg.m-2, classified as recreationally active
Who cannot join
- Cardiometabolic disease, high activity levels, Unable to tolerate the exercise intervention
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Univeristy of Hull
Hull, Kingston Upon Hull, HU67RX
About this study
Official title: The Effects of Low-Volume High Intensity Interval Training and Circuit Training on Maximal Oxygen Uptake
High intensity interval training (HIIT) and circuit training (CT) are popular methods of exercise, eliciting improvements in cardiorespiratory fitness (CRF). However direct comparisons of these two training methods are limited.
Read the detailed description
Study Design Participants were enrolled in a randomised control trial at the University of Hull to either eight weeks of High intensity interval training (HIIT) or Circuit Training (CT) (two supervised sessions per week, accompanied by an exercise physiologist). A sample size of 38 using G Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and Moderate Intensity Continuous Training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study. To assess the effectiveness of the interventions as determined by maximal oxygen consumption (VO2max), a maximal cardiopulmonary exercise test (CPET) to volitional exhaustion on an electronically braked cycle ergometer at baseline (visit one), and following an eight-week exercise intervention of HIIT or CT (visit two) was conducted. When attending the assessments participants were asked not to take part in any strenuous exercise 24 hours prior to the appointment, to wear suitable comfortable clothing and avoid a large meal. Visit two CPET was performed within six days of completing the exercise interventions. A thorough warm-up and cool down before and after each exercise session. All were asked to maintain their habitual physical activity patterns during the intervention. Body mass index (BMI) was calculated by dividing body weight by height in meters squared and was presented as kg.m-2. Resting blood pressure was measured after 15 minutes of rest using a sphygmomanometer (A.C. Cossor \& Son Ltd, London UK) and stethoscope (3M Healthcare, St Paul, MN). To provide a comprehensive account of the study the Consensus on Exercise Reporting Template (CERT) was consulted.
Participants Ethical approval was provided by the School of Life Sciences ethics committee at the University of Hull which was in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. A total of 42 apparently healthy men and women between the age of 18-65 years were recruited to the study. Enrolled individuals reported no medical history of cardiometabolic or limiting respiratory disease, were non-smokers, had a body mass index <30 kg.m-2, classified as recreationally active and none were taking any medication that would affect heart rate. As a condition of enrolment, those over 45 years obtained written medical clearance from a general practitioner and underwent resting and exercise 12-lead electrocardiogram (ECG) (GE Healthcare, Chalfont St Giles, United Kingdom). Written informed consent and a pre-exercise medical questionnaire was completed by all.
Cardiopulmonary Exercise Testing Maximal CPETs were conducted in accordance with the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP) guidelines. An Oxycon pro (Jaeger, Hoechburg, Germany) breath by breath metabolic cart was used to collect respiratory gas exchange data. Automatic and manual calibration evaluated ambient temperature, humidity, barometric pressure and altitude. Calibration of the air flow volume was conducted using a 3 litre syringe and by automatic calibration. Two-point gas calibration was also conducted to ensure accurate measures of inspired oxygen and expired carbon dioxide. Tests were performed on a GE e-bike ergometer (GE Healthcare, Buckinghamshire, UK) using a ramp protocol. The protocol consisted of a three-minute rest phase, three minutes of unloaded cycling, followed by a personalised ramp test (ramp rate ranged between 15 and 30 watts) with work rate continually increased every one to three seconds. Participants performed the same ramp rate pre and post testing. Participants were asked to pedal at a cadence of 70 rpm until they reached volitional exhaustion at a protocol duration between eight to twelve minutes. Self-reported rating of perceived exertion (RPE) scores using the 6-20 scale and heart rate (HR) (FT1 heart rate monitor, Polar Electro, Finland) was recorded during the last five seconds of each minute of the test, at maximum exercise and during the recovery period. Together with verbal encouragement to volitional exhaustion, VO2max was attained by participants achieving at least two of the following criteria, VO2 plateau as determined by a failure of VO2 increase by 150 ml/min with further increases in workload analysed by breath by breath gas exchange data averaged over 15 seconds, respiratory exchange ratio (RER) > 1.10, achieve > 85% age predicated heart rate maximum (HRmax) and a RPE > 17 on the 6-20 Borg scale. VO2 at the ventilatory anaerobic threshold (VAT) was defined using the V slope method and verified using ventilatory equivalents. Peak power output (PPO) (watts) and HRmax were defined as the highest value achieved during the CPET with maximum oxygen and heart rate (VO2 /HR) determined by the ratio of VO2max and HRmax.
Training Interventions The HIIT group were asked to perform ten one-minute HIIT intervals, each followed by one minute of active recovery (AR) (total exercise time 20 minutes). Resulting from the CPET, HIIT was set at above 85% HRmax with a specific HR designated for this criterion. Active recovery was set at a load corresponding to 25-50 watts. Sessions were performed on a Wattbike trainer (Wattbike Ltd, Nottingham, UK). The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand/squats, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax (calculated from CPET). No resistance equipment was involved, only body weight. Participants initially performed 20 minutes of CT with duration increased by five minutes per week until the desired 40 minutes. Each station was occupied for three to six minutes depending on session duration, moving from one station to the next with minimal rest. During both interventions, HR was measured in last 5 seconds of each station/interval using a FT1 polar heart rate monitor (Polar Electro, Finland) with each CT session timed using a stop watch (Axprod S.L, Guipuzcoa, Spain). Intensity for both interventions was adjusted throughout by the investigator to ensure an appropriate HR range and successful completion of the protocol. Participants were made aware of their HR ranges and verbal encouragement was given by the physiologist to help achieve and maintain these thresholds. Energy expenditure between HIIT and CT was not matched.
To assess the validity of the exercise interventions, participant fidelity to the desired exercise intensity was determined using cut points of >85% HRmax and 60-80% HRmax for HIIT and CT respectively and reported using previous examples. These values were calculated using the participants mean heart rate for each individual interval or station over the 16 sessions and was expressed as a percentage of HRmax as determined by CPET at visit 1. Specific fidelity thresholds were consulted to determine low (<50%), moderate (50-70%) and high (>70%) compliance. Adherence was determined as a percentage of completed sessions, with 14 (> 85%) being the threshold for completion.
Statistical Analysis Statistical analysis was conducted using Statistical Package for the Social Sciences (SPSS) version 24 (IBM, New York, USA). An independent t-test was used to identify group differences at baseline. Assumptions of normality were verified using the Shapiro-Wilk test. Skewness and kurtosis of distribution was visually examined. Non-normally distributed data was presented as median and interquartile range (IQR). A two-way (condition x time) repeated measures analysis of variance (ANOVA) was used to compare CRF pre-and post-training. Post-hoc analysis for the main effects and interactions was assessed using a Bonferroni adjustment. Group differences were compared using independent t tests. Variables were displayed as mean with 95% confidence intervals (95% CI) or standard deviation where specified. Partial eta squared effect sizes were also calculated with 0.01, 0.06 and 0.14 representing small, medium and large effect sizes, respectively.
- Conditions
- High Intensity Interval Training
- Being tested
- High intensity interval training, Circuit training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingOther
Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration
Circuit trainingOther
The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | HIIT was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry. Receives: Other: High intensity interval training |
| Circuit training | Active comparator | The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between. Receives: Other: Circuit training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Consumption (ml.Kg-1.Min-1)
Maximal oxygen consumption (ml.kg-1.min-1), as determined during a cardiopulmonary exercise test (CPET) represents the upper limit of aerobic fitness in humans. A low VO2max is associated with a greater risk of premature all-cause and cardiovascular mortality, independent of traditional risk factors and physical activity status. Conversely, increasing VO2max through exercise training may improve cardiometabolic health, quality of life and increase life-expectancy
Measured: Baseline and 8 weeks
Secondary outcomes (1)
Oxygen Consumption at the Ventilatory Anaerobic Threshold
Oxygen consumption at the Ventilatory Anaerobic Threshold ml/kg/min. This measure will assess if individuals can exercise at higher intensities before lactate accumulation, thus becoming 'physiologically efficient
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start11 May 2016
- Primary completion11 May 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (44)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomised to either high or moderate intensity exercise
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hull
- Responsible party
- Principal investigator, Stefan Birkett, University of Central Lancashire
- Investigators
- Stefan Birkett, PhD, Principal investigator, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700671
- Sponsor's protocol ID
- UCentralLancashire
- Status last verified
- Feb 2020
- First submitted
- 4 Oct 2018
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ross R, Blair SN, Arena R, Church TS, Despres JP, Franklin BA, Haskell WL, Kaminsky LA, Levine BD, Lavie CJ, Myers J, Niebauer J, Sallis R, Sawada SS, Sui X, Wisloff U; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Cardiovascular and Stroke Nursing; Council on Functional Genomics and Translational Biology; Stroke Council. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 13;134(24):e653-e699. doi: 10.1161/CIR.0000000000000461. Epub 2016 Nov 21.
PubMed 27881567Kaminsky LA, Arena R, Beckie TM, Brubaker PH, Church TS, Forman DE, Franklin BA, Gulati M, Lavie CJ, Myers J, Patel MJ, Pina IL, Weintraub WS, Williams MA; American Heart Association Advocacy Coordinating Committee, Council on Clinical Cardiology, and Council on Nutrition, Physical Activity and Metabolism. The importance of cardiorespiratory fitness in the United States: the need for a national registry: a policy statement from the American Heart Association. Circulation. 2013 Feb 5;127(5):652-62. doi: 10.1161/CIR.0b013e31827ee100. Epub 2013 Jan 7. No abstract available.
PubMed 23295916Lee DC, Artero EG, Sui X, Blair SN. Mortality trends in the general population: the importance of cardiorespiratory fitness. J Psychopharmacol. 2010 Nov;24(4 Suppl):27-35. doi: 10.1177/1359786810382057.
PubMed 20923918Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
PubMed 24144531Weston M, Taylor KL, Batterham AM, Hopkins WG. Effects of low-volume high-intensity interval training (HIT) on fitness in adults: a meta-analysis of controlled and non-controlled trials. Sports Med. 2014 Jul;44(7):1005-17. doi: 10.1007/s40279-014-0180-z.
PubMed 24743927Taylor KL, Weston M, Batterham AM. Evaluating intervention fidelity: an example from a high-intensity interval training study. PLoS One. 2015 Apr 22;10(4):e0125166. doi: 10.1371/journal.pone.0125166. eCollection 2015.
PubMed 25902066Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.
PubMed 22289907McGregor G, Nichols S, Hamborg T, Bryning L, Tudor-Edwards R, Markland D, Mercer J, Birkett S, Ennis S, Powell R, Begg B, Haykowsky MJ, Banerjee P, Ingle L, Shave R, Backx K. High-intensity interval training versus moderate-intensity steady-state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): study protocol for a multicentre randomised controlled trial and economic evaluation. BMJ Open. 2016 Nov 16;6(11):e012843. doi: 10.1136/bmjopen-2016-012843.
PubMed 27852718Esfandiari S, Sasson Z, Goodman JM. Short-term high-intensity interval and continuous moderate-intensity training improve maximal aerobic power and diastolic filling during exercise. Eur J Appl Physiol. 2014 Feb;114(2):331-43. doi: 10.1007/s00421-013-2773-x. Epub 2013 Nov 27.
PubMed 24281825Sawyer BJ, Tucker WJ, Bhammar DM, Ryder JR, Sweazea KL, Gaesser GA. Effects of high-intensity interval training and moderate-intensity continuous training on endothelial function and cardiometabolic risk markers in obese adults. J Appl Physiol (1985). 2016 Jul 1;121(1):279-88. doi: 10.1152/japplphysiol.00024.2016. Epub 2016 Jun 2.
PubMed 27255523Baekkerud FH, Solberg F, Leinan IM, Wisloff U, Karlsen T, Rognmo O. Comparison of Three Popular Exercise Modalities on V O2max in Overweight and Obese. Med Sci Sports Exerc. 2016 Mar;48(3):491-8. doi: 10.1249/MSS.0000000000000777.
PubMed 26440134Boyd JC, Simpson CA, Jung ME, Gurd BJ. Reducing the intensity and volume of interval training diminishes cardiovascular adaptation but not mitochondrial biogenesis in overweight/obese men. PLoS One. 2013 Jul 5;8(7):e68091. doi: 10.1371/journal.pone.0068091. Print 2013.
PubMed 23861854Stavrinou PS, Bogdanis GC, Giannaki CD, Terzis G, Hadjicharalambous M. High-intensity Interval Training Frequency: Cardiometabolic Effects and Quality of Life. Int J Sports Med. 2018 Feb;39(3):210-217. doi: 10.1055/s-0043-125074. Epub 2018 Feb 2.
PubMed 29396978Hood 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 21448086Little 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 21868679
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low-Volume High Intensity Interval Training and Circuit Training on Maximal Oxygen Uptake
- ClinicalTrials.gov ID
- NCT03700671
- Acronym / sponsor ID
- UCentralLancashire
- Conditions
- High Intensity Interval Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- University of Hull
- Study start
- 11 May 2016 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Posted 17 Feb 2020
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) and circuit training (CT) are popular methods of exercise, eliciting improvements in cardiorespiratory fitness (CRF). However direct comparisons of these two training methods are limited.
Detailed description
Study Design Participants were enrolled in a randomised control trial at the University of Hull to either eight weeks of High intensity interval training (HIIT) or Circuit Training (CT) (two supervised sessions per week, accompanied by an exercise physiologist). A sample size of 38 using G Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and Moderate Intensity Continuous Training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study. To assess the effectiveness of the interventions as determined by maximal oxygen consumption (VO2max), a maximal cardiopulmonary exercise test (CPET) to volitional exhaustion on an electronically braked cycle ergometer at baseline (visit one), and following an eight-week exercise intervention of HIIT or CT (visit two) was conducted. When attending the assessments participants were asked not to take part in any strenuous exercise 24 hours prior to the appointment, to wear suitable comfortable clothing and avoid a large meal. Visit two CPET was performed within six days of completing the exercise interventions. A thorough warm-up and cool down before and after each exercise session. All were asked to maintain their habitual physical activity patterns during the intervention. Body mass index (BMI) was calculated by dividing body weight by height in meters squared and was presented as kg.m-2. Resting blood pressure was measured after 15 minutes of rest using a sphygmomanometer (A.C. Cossor \& Son Ltd, London UK) and stethoscope (3M Healthcare, St Paul, MN). To provide a comprehensive account of the study the Consensus on Exercise Reporting Template (CERT) was consulted.
Participants Ethical approval was provided by the School of Life Sciences ethics committee at the University of Hull which was in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. A total of 42 apparently healthy men and women between the age of 18-65 years were recruited to the study. Enrolled individuals reported no medical history of cardiometabolic or limiting respiratory disease, were non-smokers, had a body mass index <30 kg.m-2, classified as recreationally active and none were taking any medication that would affect heart rate. As a condition of enrolment, those over 45 years obtained written medical clearance from a general practitioner and underwent resting and exercise 12-lead electrocardiogram (ECG) (GE Healthcare, Chalfont St Giles, United Kingdom). Written informed consent and a pre-exercise medical questionnaire was completed by all.
Cardiopulmonary Exercise Testing Maximal CPETs were conducted in accordance with the American Thoracic Society (ATS) and the American College of Chest Physicians (ACCP) guidelines. An Oxycon pro (Jaeger, Hoechburg, Germany) breath by breath metabolic cart was used to collect respiratory gas exchange data. Automatic and manual calibration evaluated ambient temperature, humidity, barometric pressure and altitude. Calibration of the air flow volume was conducted using a 3 litre syringe and by automatic calibration. Two-point gas calibration was also conducted to ensure accurate measures of inspired oxygen and expired carbon dioxide. Tests were performed on a GE e-bike ergometer (GE Healthcare, Buckinghamshire, UK) using a ramp protocol. The protocol consisted of a three-minute rest phase, three minutes of unloaded cycling, followed by a personalised ramp test (ramp rate ranged between 15 and 30 watts) with work rate continually increased every one to three seconds. Participants performed the same ramp rate pre and post testing. Participants were asked to pedal at a cadence of 70 rpm until they reached volitional exhaustion at a protocol duration between eight to twelve minutes. Self-reported rating of perceived exertion (RPE) scores using the 6-20 scale and heart rate (HR) (FT1 heart rate monitor, Polar Electro, Finland) was recorded during the last five seconds of each minute of the test, at maximum exercise and during the recovery period. Together with verbal encouragement to volitional exhaustion, VO2max was attained by participants achieving at least two of the following criteria, VO2 plateau as determined by a failure of VO2 increase by 150 ml/min with further increases in workload analysed by breath by breath gas exchange data averaged over 15 seconds, respiratory exchange ratio (RER) > 1.10, achieve > 85% age predicated heart rate maximum (HRmax) and a RPE > 17 on the 6-20 Borg scale. VO2 at the ventilatory anaerobic threshold (VAT) was defined using the V slope method and verified using ventilatory equivalents. Peak power output (PPO) (watts) and HRmax were defined as the highest value achieved during the CPET with maximum oxygen and heart rate (VO2 /HR) determined by the ratio of VO2max and HRmax.
Training Interventions The HIIT group were asked to perform ten one-minute HIIT intervals, each followed by one minute of active recovery (AR) (total exercise time 20 minutes). Resulting from the CPET, HIIT was set at above 85% HRmax with a specific HR designated for this criterion. Active recovery was set at a load corresponding to 25-50 watts. Sessions were performed on a Wattbike trainer (Wattbike Ltd, Nottingham, UK). The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand/squats, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax (calculated from CPET). No resistance equipment was involved, only body weight. Participants initially performed 20 minutes of CT with duration increased by five minutes per week until the desired 40 minutes. Each station was occupied for three to six minutes depending on session duration, moving from one station to the next with minimal rest. During both interventions, HR was measured in last 5 seconds of each station/interval using a FT1 polar heart rate monitor (Polar Electro, Finland) with each CT session timed using a stop watch (Axprod S.L, Guipuzcoa, Spain). Intensity for both interventions was adjusted throughout by the investigator to ensure an appropriate HR range and successful completion of the protocol. Participants were made aware of their HR ranges and verbal encouragement was given by the physiologist to help achieve and maintain these thresholds. Energy expenditure between HIIT and CT was not matched.
To assess the validity of the exercise interventions, participant fidelity to the desired exercise intensity was determined using cut points of >85% HRmax and 60-80% HRmax for HIIT and CT respectively and reported using previous examples. These values were calculated using the participants mean heart rate for each individual interval or station over the 16 sessions and was expressed as a percentage of HRmax as determined by CPET at visit 1. Specific fidelity thresholds were consulted to determine low (<50%), moderate (50-70%) and high (>70%) compliance. Adherence was determined as a percentage of completed sessions, with 14 (> 85%) being the threshold for completion.
Statistical Analysis Statistical analysis was conducted using Statistical Package for the Social Sciences (SPSS) version 24 (IBM, New York, USA). An independent t-test was used to identify group differences at baseline. Assumptions of normality were verified using the Shapiro-Wilk test. Skewness and kurtosis of distribution was visually examined. Non-normally distributed data was presented as median and interquartile range (IQR). A two-way (condition x time) repeated measures analysis of variance (ANOVA) was used to compare CRF pre-and post-training. Post-hoc analysis for the main effects and interactions was assessed using a Bonferroni adjustment. Group differences were compared using independent t tests. Variables were displayed as mean with 95% confidence intervals (95% CI) or standard deviation where specified. Partial eta squared effect sizes were also calculated with 0.01, 0.06 and 0.14 representing small, medium and large effect sizes, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomised to either high or moderate intensity exercise
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Other: High intensity interval trainingHIIT was set at > 85% HRmax. Active recovery was set at 25-50 watts. Sessions were performed using cycle ergometry. |
| Circuit training | Active comparator | Other: Circuit trainingThe CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80%. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated. Each station was occupied for three to six minutes depending on session duration with minimal rest in-between. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants reported no medical history of cardiometabolic or limiting respiratory disease, were non-smokers, had a body mass index <30 kg.m-2, classified as recreationally active
Key exclusion criteria (1 listed)
- Cardiometabolic disease, high activity levels, Unable to tolerate the exercise intervention
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 trainingParticipants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration | Other | High intensity interval training |
| Circuit trainingThe CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated | Other | Circuit training |
Primary outcome
Maximal Oxygen Consumption (ml.Kg-1.Min-1)
Time frame: Baseline and 8 weeks
Maximal oxygen consumption (ml.kg-1.min-1), as determined during a cardiopulmonary exercise test (CPET) represents the upper limit of aerobic fitness in humans. A low VO2max is associated with a greater risk of premature all-cause and cardiovascular mortality, independent of traditional risk factors and physical activity status. Conversely, increasing VO2max through exercise training may improve cardiometabolic health, quality of life and increase life-expectancy
1 secondary outcome
Oxygen Consumption at the Ventilatory Anaerobic Threshold
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27881567Ross R, Blair SN, Arena R, Church TS, Despres JP, Franklin BA, Haskell WL, Kaminsky LA, Levine BD, Lavie CJ, Myers J, Niebauer J, Sallis R, Sawada SS, Sui X, Wisloff U; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Cardiovascular and Stroke Nursing; Council on Functional Genomics and Translational Biology; Stroke Council. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 13;134(24):e653-e699. doi: 10.1161/CIR.0000000000000461. Epub 2016 Nov 21.
- Background: PubMed 23295916Kaminsky LA, Arena R, Beckie TM, Brubaker PH, Church TS, Forman DE, Franklin BA, Gulati M, Lavie CJ, Myers J, Patel MJ, Pina IL, Weintraub WS, Williams MA; American Heart Association Advocacy Coordinating Committee, Council on Clinical Cardiology, and Council on Nutrition, Physical Activity and Metabolism. The importance of cardiorespiratory fitness in the United States: the need for a national registry: a policy statement from the American Heart Association. Circulation. 2013 Feb 5;127(5):652-62. doi: 10.1161/CIR.0b013e31827ee100. Epub 2013 Jan 7. No abstract available.
- Background: PubMed 20923918Lee DC, Artero EG, Sui X, Blair SN. Mortality trends in the general population: the importance of cardiorespiratory fitness. J Psychopharmacol. 2010 Nov;24(4 Suppl):27-35. doi: 10.1177/1359786810382057.
- Background: PubMed 24144531Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
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- 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.
Stefan Birkett, PhD principal investigator
University of Central Lancashire
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 and Circuit training in people with High Intensity Interval Training, run by University of Central Lancashire at 1 site in United Kingdom.
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 17 Feb 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximal Oxygen Consumption (ml.Kg-1.Min-1) (time frame: Baseline and 8 weeks). 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 NCT03700671, which also lists 44 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 17 Feb 2020.