Study Stopped
COVID associated costs have reduced the available budget , and the ability to recruit participants from the community. These two factors combined do not allow us to perform the trial as originally planned.
Addressing Individual Variability in Response to Exercise
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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?
Trial Health
Trial Health Score
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Started Jan 2022
Longer than P75 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJune 22, 2022
September 1, 2021
4.2 years
February 28, 2020
June 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in cardiometabolic risk factors
Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factor
Measured at baseline, 16 and 32 weeks.
Study Arms (5)
Low amount, low intensity
EXPERIMENTALLow amount, high intensity
EXPERIMENTALHigh Amount, low intensity
EXPERIMENTALHigh Amount, high intensity
EXPERIMENTALControl
NO INTERVENTIONInterventions
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Robert Rosslead
- Canadian Institutes of Health Research (CIHR)collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- exercise trial, no blinding
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 28, 2020
First Posted
March 11, 2020
Study Start
January 1, 2022
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
June 22, 2022
Record last verified: 2021-09