NCT03376685

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.5 years

First QC Date

December 6, 2017

Last Update Submit

April 27, 2020

Conditions

Keywords

Endurance trainingSprint interval trainingGlycemic regulationLipid homeostasisCardiovascular health

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (11)

  • Blood lipids

    Baseline (pre-training) vs. week 6 (post-training)

  • HbA1C

    Baseline (pre-training) vs. week 6 (post-training)

  • Post-prandial blood lipids

    Baseline (pre-training) vs. week 6 (post-training)

  • Blood pressure

    Baseline (pre-training) vs. week 6 (post-training)

  • Body composition

    Baseline (pre-training) vs. week 6 (post-training)

  • +6 more secondary outcomes

Study Arms (2)

Endurance Exercise Training (END)

EXPERIMENTAL

This group is performing END training for 6 weeks in duration. Intervention: Behavioral: Endurance Exercise Training (END)

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)

Behavioral: Sprint Exercise Training (SIT)

Interventions

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.

Endurance Exercise Training (END)

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.

Sprint Exercise Training (SIT)

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+)

You may not qualify if:

  • Prescribed with glucose lowering medications
  • Smoker
  • Not cleared for physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jamie Burr, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR
  • Graham Holloway, PhD

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study is a 6-week exercise training study, with two possible parallel training groups: endurance (END) or sprint (SIT) training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jamie Burr, Director, Human Performance and Health Laboratory, Principal Investigator, Assistant Professor, PhD

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 18, 2017

Study Start

May 30, 2018

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations