Exercise Clinical Trial
Official title:
Addressing Individual Variability in Response to Exercise
NCT number | NCT04304092 |
Other study ID # | Ross2019 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | April 1, 2026 |
Verified date | September 2021 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this proposal, the investigators challenge the assumption that following the physical activity guidelines implies benefit for ALL adults, and that if benefit is not achieved in response to first line therapy, it will be by simply exercising more. Thus, for improving cardiorespiratory fitness and cardiometabolic risk factors, unanswered questions include: 1) To what extent, regardless of exercise amount or intensity, is exercise not associated with benefit? Demonstration of a resistance to benefit through exercise in a substantial number of adults would be a novel and important finding, would counter the assumptions of many if not most health care practitioners, and could have immediate and direct application in all health care settings. 2) To what extent will non-responders to first line therapy (150 min/wk) be required to increase exercise amount or intensity to achieve benefit? 3) To what extent will failure to improve CRF segregate (be associate with) with cardiometabolic risk factors? The investigators propose that adults who remain exercise resistant for improvement in CRF and cardiometabolic risk despite increasing amount or intensity are at high risk of metabolic disease and consequently, are candidates for alternative treatment strategies. 4) To what extent is biological sex and/or phenotype a determinant of response or non-response to exercise?
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 1, 2026 |
Est. primary completion date | April 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 60 Years |
Eligibility | Inclusion Criteria: - Sedentary lifestyle (planned physical activity for one day per week or less). - Weight stable (± 2 kg) for 6 months prior to the beginning of the study. - BMI between 20 and 40 kg/m2. Exclusion Criteria: - Physical impairment which would make the intervention very difficult or unsafe according to doctor's advice. - Diabetes, current smokers. - Plan to move from the area in next 8 months. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Robert Ross | Canadian Institutes of Health Research (CIHR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cardiorespiratory Fitness | Cardiorespiratory fitness will be determined using direct (open circuit spirometry) measures of oxygen consumption (expressed in L/min) obtained during a maximal treadmill test. | Measured at baseline and every 4 weeks for 32 weeks. | |
Secondary | Change in cardiometabolic risk factors | Fasting glucose (mmol/L) | Measured at baseline, 16 and 32 weeks. | |
Secondary | Change in cardiometabolic risk factors | Fasting LDL- and HDL-cholesterol (mmol/L) | Measured at baseline, 16 and 32 weeks. | |
Secondary | Change in cardiometabolic risk factors | fasting insulin (pmol/L) | Measured at baseline, 16 and 32 weeks. | |
Secondary | Change in cardiometabolic risk factor | fasting triglycerides (mmol/L) | Measured at baseline, 16 and 32 weeks. |
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