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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376685
Other study ID # 17-08-008
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2018
Est. completion date November 18, 2019

Study information

Verified date April 2020
Source University of Guelph
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date November 18, 2019
Est. primary completion date November 18, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
Canada University of Guelph Guelph Ontario

Sponsors (1)

Lead Sponsor Collaborator
University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiorespiratory fitness 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)
Primary 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 Baseline (pre-training) vs. week 6 (post-training)
Primary Glucose tolerance 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 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 Baseline (pre-training) vs. week 6 (post-training)
Secondary HbA1C Change in HbA1C assessed via fasted venous blood sampling, following 6-weeks of exercise training Baseline (pre-training) vs. week 6 (post-training)
Secondary 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 Baseline (pre-training) vs. week 6 (post-training)
Secondary Blood pressure Assessed via automated brachial blood pressure (including systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP)) Baseline (pre-training) vs. week 6 (post-training)
Secondary 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. Baseline (pre-training) vs. week 6 (post-training)
Secondary Arterial stiffness Assessed via carotid-femoral pulse wave velocity (PWV) Baseline (pre-training) vs. week 6 (post-training)
Secondary 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 Acutely pre-exercise vs. post-exercise in week 1 of training
Secondary Brachial artery vascular function Assessed via brachial artery flow mediated dilation (FMD) following 6-weeks of exercise training Baseline (pre-training) vs. week 6 (post-training)
Secondary 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 Acutely pre-exercise vs. post-exercise in week 1 of training
Secondary Daily sedentary/active time Assessed via accelerometer Baseline (pre-training), week 1 (of training), week 6 (post-training)
Secondary Free-living glycemic regulation during the first week of exercise training Assessed via continuous glucose monitoring (CGM) Baseline (pre-training) vs. week 1 (of training)
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