Overweight or ObesityNCT03376685
The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
A study testing Endurance Exercise Training (END) and Sprint Exercise Training (SIT) in people with Overweight or Obesity, run by University of Guelph at 1 site in Canada.
Trial summary
Regular physical activity is well established to decrease the risk of cardiometabolic diseases. While research has characterized responses based on exercise intensity, many beneficial effects of exercise are transient in nature, and therefore exercise frequency may play an important, yet currently under-appreciated… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Overweight or Obesity
- What is being tested?
- Endurance Exercise Training (END) and Sprint Exercise Training (SIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2018to 18 Nov 2019
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged 18-70 years
- Body mass index (BMI) > 25 kg/m^2 (classified as overweight or obese)
- Sedentary (<100 minutes moderate physical activity per week)
- Approval for vigorous exercise via physical activity readiness questionnaire (PARQ+)
Who cannot join
- Prescribed with glucose lowering medications
- Smoker
- Not cleared for physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Regular physical activity is well established to decrease the risk of cardiometabolic diseases. While research has characterized responses based on exercise intensity, many beneficial effects of exercise are transient in nature, and therefore exercise frequency may play an important, yet currently under-appreciated, role in improving health. The purpose of this study is to determine the efficacy of 6-week high-frequency endurance (END) or low-frequency sprint (SIT) training with respect to reducing clinically relevant cardiometabolic risk factors in overweight/obese males. It is hypothesized that END, performed at a greater frequency than SIT, will markedly improve cardiometabolic health, while low-frequency SIT will not.
Read the detailed description
Involvement in regular physical activity is known to elicit systemic adaptations and reduce the risk of cardiometabolic diseases, including hypertension, obesity, dyslipidemia, and hyperglycemia. Traditional physical activity recommendations suggest that 150 minutes of moderate-intensity continuous endurance (END) exercise dispersed over 5 days per week is sufficient to improve physical fitness in adults. However, given the commonly cited barrier of "lack of time," literature has recently focused on time effective sprint interval training (SIT), obtaining equivalent increases in aerobic capacity and acute glycemic regulation compared to classical END exercise when protocols are work-matched. Despite these similarities, END is conducive to daily sessions not feasible of SIT. As improvements in many clinically relevant risk factors are transient in nature following exercise, it remains imperative to assess the implications of variable frequency exercise regimes performed as per general practice (i.e. high-frequency END, low-frequency SIT). Furthermore, improvements in cardiovascular outcomes following END have been shown, in some instances, to be absent in response to SIT, suggesting END may be more beneficial for cardiovascular health. Therefore, the current study aims to assess several markers of cardiovascular (aerobic capacity, blood pressure, arterial stiffness, vascular endothelial function) and metabolic (glucose tolerance, lipid tolerance, body composition) health following 6-weeks of high-frequency END or low-frequency SIT, performed as per general practice. Combined, this research will provide important insight into the under-appreciated role of exercise frequency for improving cardiometabolic health.
- Conditions
- Overweight or Obesity
- Being tested
- Endurance Exercise Training (END), Sprint Exercise Training (SIT)
- Keywords
- Endurance training, Sprint interval training, Glycemic regulation, Lipid homeostasis, Cardiovascular health
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance Exercise Training (END)Behavioural
Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 5 days a week for 30 minutes (Week 1-2); 35 minutes (Weeks 3-4); or 40 minutes (Weeks 5-6) at 60% VO2 peak.
Sprint Exercise Training (SIT)Behavioural
Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 3 days a week involving a 3-minute warm-up, followed up 4 repetitions (Week 1-2); 5 repetitions (Weeks 3-4); or 6 (Weeks 5-6) repetitions of 30 seconds at a maximal intensity with 2 minutes' rest in between. Exercise will conclude with a 2-minute cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Endurance Exercise Training (END) | Experimental | This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END) Receives: Behavioral: Endurance Exercise Training (END) |
| Sprint Exercise Training (SIT) | Experimental | This group is performing SIT training for 6 weeks in duration. Intervention: Behavioral: Sprint Exercise Training (SIT) Receives: Behavioral: Sprint Exercise Training (SIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Assessed via VO2 peak test, to determine the change in cardiorespiratory fitness following 6-weeks of exercise training
Measured: Baseline (pre-training) vs. week 6 (post-training)
Free-living glycemic regulation
Assessed via continuous glucose monitoring (CGM), to determine the change in free-living glycemic regulation following 6-weeks of exercise training
Measured: Baseline (pre-training) vs. week 6 (post-training)
Glucose tolerance
Assessed via an oral glucose tolerance test (OGTT) to determine changes in standardized glycemic regulation following 6-weeks of exercise training
Measured: Baseline (pre-training) vs. week 6 (post-training)
Secondary outcomes (11)
Blood lipids
Blood lipid profile from fasted venous blood sampling, including high-density lipoproteins (HDL), low-density lipoproteins (LDL), high-sensitivity C-reactive protein (Hs-CRP), cholesterol, non-HDL cholesterol, triglycerides (TAG), free-fatty acids (FFA), and cholesterol/HDL ratio
Measured: Baseline (pre-training) vs. week 6 (post-training)
HbA1C
Change in HbA1C assessed via fasted venous blood sampling, following 6-weeks of exercise training
Measured: Baseline (pre-training) vs. week 6 (post-training)
Post-prandial blood lipids
Assessed following the consumption of an oral fat tolerance test (OFTT). Blood lipid responses include triglycerides (TAG) and free fatty acids (FFA), assessing the influence of 6-weeks of exercise training on these parameters
Measured: Baseline (pre-training) vs. week 6 (post-training)
Blood pressure
Assessed via automated brachial blood pressure (including systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP))
Measured: Baseline (pre-training) vs. week 6 (post-training)
Body composition
Assessed via dual-energy X-ray absorptiometry (DXA); including total and regional lean and fat mass. Assessed via height and weight measurements to determine BMI.
Measured: Baseline (pre-training) vs. week 6 (post-training)
Arterial stiffness
Assessed via carotid-femoral pulse wave velocity (PWV)
Measured: Baseline (pre-training) vs. week 6 (post-training)
Arterial stiffness acutely post-exercise
Assessed via carotid-femoral pulse wave velocity (PWV) following a single bout of exercise in week 1 of each group
Measured: Acutely pre-exercise vs. post-exercise in week 1 of training
Brachial artery vascular function
Assessed via brachial artery flow mediated dilation (FMD) following 6-weeks of exercise training
Measured: Baseline (pre-training) vs. week 6 (post-training)
Brachial artery vascular function acutely post-exercise
Assessed via brachial artery flow mediated dilation (FMD) following a single bout of exercise in week 1 of each training group
Measured: Acutely pre-exercise vs. post-exercise in week 1 of training
Daily sedentary/active time
Assessed via accelerometer
Measured: Baseline (pre-training), week 1 (of training), week 6 (post-training)
Free-living glycemic regulation during the first week of exercise training
Assessed via continuous glucose monitoring (CGM)
Measured: Baseline (pre-training) vs. week 1 (of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start30 May 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a 6-week exercise training study, with two possible parallel training groups: endurance (END) or sprint (SIT) training.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Burr, University of Guelph
- Investigators
- Jamie Burr, PhD, Principal investigator, University of GuelphGraham Holloway, PhD, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376685
- Sponsor's protocol ID
- 17-08-008
- Status last verified
- Apr 2020
- First submitted
- 6 Dec 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Petrick HL, King TJ, Pignanelli C, Vanderlinde TE, Cohen JN, Holloway GP, Burr JF. Endurance and Sprint Training Improve Glycemia and V O2peak but only Frequent Endurance Benefits Blood Pressure and Lipidemia. Med Sci Sports Exerc. 2021 Jun 1;53(6):1194-1205. doi: 10.1249/MSS.0000000000002582.
PubMed 33315809
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT03376685
- Acronym / sponsor ID
- 17-08-008
- Conditions
- Overweight or Obesity
- Keywords
- Endurance training, Sprint interval training, Glycemic regulation, Lipid homeostasis, Cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 18 Dec 2017 (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.
Regular physical activity is well established to decrease the risk of cardiometabolic diseases. While research has characterized responses based on exercise intensity, many beneficial effects of exercise are transient in nature, and therefore exercise frequency may play an important, yet currently under-appreciated, role in improving health. The purpose of this study is to determine the efficacy of 6-week high-frequency endurance (END) or low-frequency sprint (SIT) training with respect to reducing clinically relevant cardiometabolic risk factors in overweight/obese males. It is hypothesized that END, performed at a greater frequency than SIT, will markedly improve cardiometabolic health, while low-frequency SIT will not.
Detailed description
Involvement in regular physical activity is known to elicit systemic adaptations and reduce the risk of cardiometabolic diseases, including hypertension, obesity, dyslipidemia, and hyperglycemia. Traditional physical activity recommendations suggest that 150 minutes of moderate-intensity continuous endurance (END) exercise dispersed over 5 days per week is sufficient to improve physical fitness in adults. However, given the commonly cited barrier of "lack of time," literature has recently focused on time effective sprint interval training (SIT), obtaining equivalent increases in aerobic capacity and acute glycemic regulation compared to classical END exercise when protocols are work-matched. Despite these similarities, END is conducive to daily sessions not feasible of SIT. As improvements in many clinically relevant risk factors are transient in nature following exercise, it remains imperative to assess the implications of variable frequency exercise regimes performed as per general practice (i.e. high-frequency END, low-frequency SIT). Furthermore, improvements in cardiovascular outcomes following END have been shown, in some instances, to be absent in response to SIT, suggesting END may be more beneficial for cardiovascular health. Therefore, the current study aims to assess several markers of cardiovascular (aerobic capacity, blood pressure, arterial stiffness, vascular endothelial function) and metabolic (glucose tolerance, lipid tolerance, body composition) health following 6-weeks of high-frequency END or low-frequency SIT, performed as per general practice. Combined, this research will provide important insight into the under-appreciated role of exercise frequency for improving cardiometabolic health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a 6-week exercise training study, with two possible parallel training groups: endurance (END) or sprint (SIT) training.
| Arm | Type | Receives |
|---|---|---|
| Endurance Exercise Training (END) | Experimental | Behavioral: Endurance Exercise Training (END)This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END) |
| Sprint Exercise Training (SIT) | Experimental | Behavioral: Sprint Exercise Training (SIT)This group is performing SIT training for 6 weeks in duration. Intervention: Behavioral: Sprint Exercise Training (SIT) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male, aged 18-70 years
- Body mass index (BMI) > 25 kg/m^2 (classified as overweight or obese)
- Sedentary (<100 minutes moderate physical activity per week)
- Approval for vigorous exercise via physical activity readiness questionnaire (PARQ+)
Key exclusion criteria (3 listed)
- Prescribed with glucose lowering medications
- Smoker
- Not cleared for physical activity
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 |
|---|---|---|
| Endurance Exercise Training (END)Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 5 days a week for 30 minutes (Week 1-2); 35 minutes (Weeks 3-4); or 40 minutes (Weeks 5-6) at 60% VO2 peak. | Behavioural | Endurance Exercise Training (END) |
| Sprint Exercise Training (SIT)Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 3 days a week involving a 3-minute warm-up, followed up 4 repetitions (Week 1-2); 5 repetitions (Weeks 3-4); or 6 (Weeks 5-6) repetitions of 30 seconds at a maximal intensity with 2 minutes' rest in between. Exercise will conclude with a 2-minute cool-down. | Behavioural | Sprint Exercise Training (SIT) |
Primary outcome
Cardiorespiratory fitness
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Assessed via VO2 peak test, to determine the change in cardiorespiratory fitness following 6-weeks of exercise training
Free-living glycemic regulation
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Assessed via continuous glucose monitoring (CGM), to determine the change in free-living glycemic regulation following 6-weeks of exercise training
Glucose tolerance
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Assessed via an oral glucose tolerance test (OGTT) to determine changes in standardized glycemic regulation following 6-weeks of exercise training
11 secondary outcomes
Blood lipids
Time frame: Baseline (pre-training) vs. week 6 (post-training)
HbA1C
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Post-prandial blood lipids
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Blood pressure
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Body composition
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Arterial stiffness
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Arterial stiffness acutely post-exercise
Time frame: Acutely pre-exercise vs. post-exercise in week 1 of training
Brachial artery vascular function
Time frame: Baseline (pre-training) vs. week 6 (post-training)
Brachial artery vascular function acutely post-exercise
Time frame: Acutely pre-exercise vs. post-exercise in week 1 of training
Daily sedentary/active time
Time frame: Baseline (pre-training), week 1 (of training), week 6 (post-training)
Free-living glycemic regulation during the first week of exercise training
Time frame: Baseline (pre-training) vs. week 1 (of training)
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 29 Apr 2020.
- Derived from this study: PubMed 33315809Petrick HL, King TJ, Pignanelli C, Vanderlinde TE, Cohen JN, Holloway GP, Burr JF. Endurance and Sprint Training Improve Glycemia and V O2peak but only Frequent Endurance Benefits Blood Pressure and Lipidemia. Med Sci Sports Exerc. 2021 Jun 1;53(6):1194-1205. doi: 10.1249/MSS.0000000000002582.
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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.
Jamie Burr, PhD principal investigator
University of Guelph
Graham Holloway, PhD principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance Exercise Training (END) and Sprint Exercise Training (SIT) in people with Overweight or Obesity, run by University of Guelph 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 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: finished, as of the sponsor's last update on 29 Apr 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 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?
Cardiorespiratory fitness (time frame: Baseline (pre-training) vs. week 6 (post-training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03376685, which also lists 1 linked publication.
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 29 Apr 2020.