Improving Individual Glycemic Response With Exercise Intensity
INTENSITY
1 other identifier
interventional
61
1 country
1
Brief Summary
Large interindividual variability exists in the glycemic response to exercise program, resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the intensity of an exercise intervention has been proposed as one method for rescuing NRs by producing beneficial changes. However, this theory has not been tested on NRs classified using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise intervention will elicit a response within previous exercise NRs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedMay 18, 2022
May 1, 2022
2.3 years
December 21, 2018
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Exercise responders following initial program
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Week 17
Exercise responders following additional exercise program
The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin
Week 30
Secondary Outcomes (13)
Sex
Baseline
Family history of cardiovascular disease
Baseline
Family history of cardiometabolic disease
Baseline
Current medication use
Baseline
Physical activity patterns
Baseline
- +8 more secondary outcomes
Study Arms (3)
Controls
NO INTERVENTIONThe primary purpose of the control participants are to provide a measure of variability. They will be used in our calculations of typical error to classify participants as responders or non-responders, and to quantify inter-individual variability.
Exercisers (Maintained)
EXPERIMENTALThe maintained exercise group will complete the original 16-week exercise intervention at an intensity of 4.5 metabolic equivalents (METs), and repeat the intervention for another 12-weeks following its completion.
Exercisers (Increased Intensity)
EXPERIMENTALThe increased intensity exercise group will complete the original 16-week exercise intervention, followed by an additional 12 week intervention completed at an intensity of 6.0 METs.
Interventions
Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing. Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs). Duration: Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week Week 17: Physiological Testing Week 18 - 29 Intensity: 4.5 METs Duration: 150 minutes/week All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.
Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing. Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs). Duration: Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week Week 17: Physiological Testing Week 18 - 29 Intensity: 6.0 METs Duration: 150 minutes/week All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.
Eligibility Criteria
You may qualify if:
- Community-dwelling adults aged 19 years or older.
- Currently living with prediabetes or T2DM as diagnosed by a physician and confirmed by an HbA1c value of 5.7% or above, as verified by duplicate testing.
- Not currently partaking in a self-reported regular physical activity regimen, defined as consistent participation in running or jogging activity, attending physical activity or exercise classes on a weekly basis, or averaging 10,000 steps per day or more over the course of 7 days.
You may not qualify if:
- Self reported as currently diagnosed as having, or being treated for, low iron concentrations or anemia.
- Diagnosed with any red blood cell altering condition.
- Currently living with any cardiovascular disease which would impact the ability to safely participate in exercise training.
- Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track exercise intensity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of New Brunswicklead
- Heart and Stroke Foundation of Canadacollaborator
- New Brunswick Health Research Foundationcollaborator
Study Sites (1)
University of New Brunswick
Fredericton, New Brunswick, E3B 5A3, Canada
Related Publications (5)
Hecksteden A, Pitsch W, Rosenberger F, Meyer T. Repeated testing for the assessment of individual response to exercise training. J Appl Physiol (1985). 2018 Jun 1;124(6):1567-1579. doi: 10.1152/japplphysiol.00896.2017. Epub 2018 Jan 11.
PMID: 29357481BACKGROUNDMontero D, Lundby C. Refuting the myth of non-response to exercise training: 'non-responders' do respond to higher dose of training. J Physiol. 2017 Jun 1;595(11):3377-3387. doi: 10.1113/JP273480. Epub 2017 May 14.
PMID: 28133739BACKGROUNDde Lannoy L, Clarke J, Stotz PJ, Ross R. Effects of intensity and amount of exercise on measures of insulin and glucose: Analysis of inter-individual variability. PLoS One. 2017 May 11;12(5):e0177095. doi: 10.1371/journal.pone.0177095. eCollection 2017.
PMID: 28493912BACKGROUNDThomson A, Paudel Y, Rioux B, Hrubeniuk T, Senechal M. Type 2 diabetes duration and irisin response after an aerobic exercise intervention: results from the INTENSITY study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0533.
PMID: 40456183DERIVEDHrubeniuk TJ, Bouchard DR, Gurd BJ, Senechal M. Can non-responders be 'rescued' by increasing exercise intensity? A quasi-experimental trial of individual responses among humans living with pre-diabetes or type 2 diabetes mellitus in Canada. BMJ Open. 2021 Apr 5;11(4):e044478. doi: 10.1136/bmjopen-2020-044478.
PMID: 33820788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Senechal, PhD
University of New Brunswick
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 26, 2018
Study Start
May 1, 2019
Primary Completion
July 31, 2021
Study Completion
July 31, 2021
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share