The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
Primary Purpose
Overweight or Obesity
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Endurance Exercise Training (END)
Sprint Exercise Training (SIT)
Sponsored by

About this trial
This is an interventional prevention trial for Overweight or Obesity focused on measuring Endurance training, Sprint interval training, Glycemic regulation, Lipid homeostasis, Cardiovascular health
Eligibility Criteria
Inclusion Criteria:
- 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+)
Exclusion Criteria:
- Prescribed with glucose lowering medications
- Smoker
- Not cleared for physical activity
Sites / Locations
- University of Guelph
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Endurance Exercise Training (END)
Sprint Exercise Training (SIT)
Arm Description
This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END)
This group is performing SIT training for 6 weeks in duration. Intervention: Behavioral: Sprint Exercise Training (SIT)
Outcomes
Primary Outcome Measures
Cardiorespiratory fitness
Assessed via VO2 peak test, to determine the change in cardiorespiratory fitness following 6-weeks of exercise 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
Glucose tolerance
Assessed via an oral glucose tolerance test (OGTT) to determine changes in standardized glycemic regulation following 6-weeks of exercise training
Secondary Outcome Measures
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
HbA1C
Change in HbA1C assessed via fasted venous blood sampling, following 6-weeks of exercise 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
Blood pressure
Assessed via automated brachial blood pressure (including systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP))
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.
Arterial stiffness
Assessed via carotid-femoral pulse wave velocity (PWV)
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
Brachial artery vascular function
Assessed via brachial artery flow mediated dilation (FMD) following 6-weeks of exercise 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
Daily sedentary/active time
Assessed via accelerometer
Free-living glycemic regulation during the first week of exercise training
Assessed via continuous glucose monitoring (CGM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03376685
Brief Title
The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
Official Title
The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
November 18, 2019 (Actual)
Study Completion Date
November 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight or Obesity
Keywords
Endurance training, Sprint interval training, Glycemic regulation, Lipid homeostasis, Cardiovascular health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endurance Exercise Training (END)
Arm Type
Experimental
Arm Description
This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END)
Arm Title
Sprint Exercise Training (SIT)
Arm Type
Experimental
Arm Description
This group is performing SIT training for 6 weeks in duration. Intervention: Behavioral: Sprint Exercise Training (SIT)
Intervention Type
Behavioral
Intervention Name(s)
Endurance Exercise Training (END)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sprint Exercise Training (SIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Assessed via VO2 peak test, to determine the change in cardiorespiratory fitness following 6-weeks of exercise training
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Free-living glycemic regulation
Description
Assessed via continuous glucose monitoring (CGM), to determine the change in free-living glycemic regulation following 6-weeks of exercise training
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Glucose tolerance
Description
Assessed via an oral glucose tolerance test (OGTT) to determine changes in standardized glycemic regulation following 6-weeks of exercise training
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Secondary Outcome Measure Information:
Title
Blood lipids
Description
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
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
HbA1C
Description
Change in HbA1C assessed via fasted venous blood sampling, following 6-weeks of exercise training
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Post-prandial blood lipids
Description
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
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Blood pressure
Description
Assessed via automated brachial blood pressure (including systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP))
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Body composition
Description
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.
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Arterial stiffness
Description
Assessed via carotid-femoral pulse wave velocity (PWV)
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Arterial stiffness acutely post-exercise
Description
Assessed via carotid-femoral pulse wave velocity (PWV) following a single bout of exercise in week 1 of each group
Time Frame
Acutely pre-exercise vs. post-exercise in week 1 of training
Title
Brachial artery vascular function
Description
Assessed via brachial artery flow mediated dilation (FMD) following 6-weeks of exercise training
Time Frame
Baseline (pre-training) vs. week 6 (post-training)
Title
Brachial artery vascular function acutely post-exercise
Description
Assessed via brachial artery flow mediated dilation (FMD) following a single bout of exercise in week 1 of each training group
Time Frame
Acutely pre-exercise vs. post-exercise in week 1 of training
Title
Daily sedentary/active time
Description
Assessed via accelerometer
Time Frame
Baseline (pre-training), week 1 (of training), week 6 (post-training)
Title
Free-living glycemic regulation during the first week of exercise training
Description
Assessed via continuous glucose monitoring (CGM)
Time Frame
Baseline (pre-training) vs. week 1 (of training)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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+)
Exclusion Criteria:
Prescribed with glucose lowering medications
Smoker
Not cleared for physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie Burr, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Graham Holloway, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
33315809
Citation
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.
Results Reference
derived
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The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
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