- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376685
The Relationship Between Exercise Frequency, Intensity, and Restoration of Cardiometabolic Health
April 27, 2020 updated by: Jamie Burr, University of Guelph
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 2W1
- University of Guelph
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endurance Exercise Training (END)
This group is performing END training for 6 weeks in duration.
Intervention: Behavioral: 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.
|
Experimental: Sprint Exercise Training (SIT)
This group is performing SIT training for 6 weeks in duration.
Intervention: Behavioral: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline (pre-training) vs. week 6 (post-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
|
Baseline (pre-training) vs. week 6 (post-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
|
Baseline (pre-training) vs. week 6 (post-training)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood lipids
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
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
|
Baseline (pre-training) vs. week 6 (post-training)
|
HbA1C
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
Change in HbA1C assessed via fasted venous blood sampling, following 6-weeks of exercise training
|
Baseline (pre-training) vs. week 6 (post-training)
|
Post-prandial blood lipids
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
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
|
Baseline (pre-training) vs. week 6 (post-training)
|
Blood pressure
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
Assessed via automated brachial blood pressure (including systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP))
|
Baseline (pre-training) vs. week 6 (post-training)
|
Body composition
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
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.
|
Baseline (pre-training) vs. week 6 (post-training)
|
Arterial stiffness
Time Frame: Baseline (pre-training) vs. week 6 (post-training)
|
Assessed via carotid-femoral pulse wave velocity (PWV)
|
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
|
Assessed via carotid-femoral pulse wave velocity (PWV) following a single bout of exercise in week 1 of each group
|
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)
|
Assessed via brachial artery flow mediated dilation (FMD) following 6-weeks of exercise training
|
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
|
Assessed via brachial artery flow mediated dilation (FMD) following a single bout of exercise in week 1 of each training group
|
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)
|
Assessed via accelerometer
|
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)
|
Assessed via continuous glucose monitoring (CGM)
|
Baseline (pre-training) vs. week 1 (of training)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jamie Burr, PhD, University of Guelph
- Principal Investigator: Graham Holloway, PhD, University of Guelph
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2018
Primary Completion (Actual)
November 18, 2019
Study Completion (Actual)
November 18, 2019
Study Registration Dates
First Submitted
December 6, 2017
First Submitted That Met QC Criteria
December 12, 2017
First Posted (Actual)
December 18, 2017
Study Record Updates
Last Update Posted (Actual)
April 29, 2020
Last Update Submitted That Met QC Criteria
April 27, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-08-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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