University of New Brunswick
Fredericton, New Brunswick, E3B 5A3, Canada
NCT Number: NCT03787836
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.
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Notify Me19 year–85 year
All sexes
Interventional
Not applicable
Fredericton, New Brunswick, E3B 5A3, Canada
Exercise can effectively slow the progression towards Type 2 diabetes (T2D). However, data suggest large interindividual variability exists in glycemic response to exercise, resulting in a subset of individuals known as exercise non-responders (NRs). Emerging research proposes that altering the parameters of an exercise intervention to provide a sufficient stimulus can elicit a response in those previously identified as NRs. To date, no research has attempted to rescue previously classified NRs based on glycemic outcomes by altering the parameters of an exercise intervention.
This study will implement an exercise program targeted at achieving the Canadian Physical Activity Guidelines, and calculate the number of NRs. We will then evaluate if increasing the intensity of exercise will elicit response to the treatment in the NRs.
Sixty adults living with prediabetes or T2D will be recruited into one of a control group, or an exercise group. The exercising participants will begin a 16-week exercise intervention, targeted at achieving 150 minutes of moderate to vigorous intensity (equating to 4.5 METs) aerobic physical activity per week. Following the 16-week exercise program, participants will be randomized into two groups, each completing an additional 12 weeks of exercise. The first will maintain the same time and intensity, while the other will complete the 150 minutes per week at an intensity equal to 6.0 METs. Randomization will occur in blocks in order to ensure an equal number of NRs in each group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Week 17
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Time frame: Week 30
The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin
Time frame: Baseline
Participant self-reported biological sex
Time frame: Baseline
Self-reported family history of cardiovascular disease
Time frame: Baseline
Self-reported family history of cardiometabolic disease
Time frame: Baseline
Record of quantity and dose of current medications
Time frame: Baseline
Participant self-reported physical activity patterns and daily step counts over a 7-day period.
Time frame: Baseline
Daily step count as recorded over a 7-day period
Time frame: Baseline, week 17 and week 30
Body mass (kilograms)
Time frame: Baseline, week 17 and week 30
Height (centimetres)
Time frame: Baseline, week 17 and week 30
Waist circumference (cm)
Time frame: Baseline, week 17 and week 30
Fat mass (kg)
Time frame: Baseline, week 17 and week 30
Fat free mass (kg)
Time frame: Baseline, week 17 and week 30
VO2 peak
Time frame: Baseline, week 17, week 30
Weight (kilograms) and height (measured in centimetres and converted to metres) will be combined to report body mass index in kg/m^2
University of New Brunswick
Other
Acronym: INTENSITY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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