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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Endurance Exercise Training (END)
This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END)
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)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Guelph

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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