Response Variability to Exercise
REVISE
1 other identifier
interventional
200
1 country
1
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 increasing exercise intensity or amount, 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 intensity or amount 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
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
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
September 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedMarch 20, 2025
March 1, 2025
3 years
August 9, 2022
March 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 (10)
Change in glucose
Measured at baseline, 16 and 32 weeks.
Change in blood lipids
Measured at baseline, 16 and 32 weeks.]
Change in insulin
Measured at baseline, 16 and 32 weeks.]
Change in triglycerides
Measured at baseline, 16 and 32 weeks.
Change in body fat
Measured at baseline, 16 and 32 weeks
- +5 more secondary outcomes
Study Arms (4)
Low amount, low intensity exercise
EXPERIMENTALexercise dose (amount and intensity) will be controlled.
Low amount, high intensity exercise
EXPERIMENTALexercise dose (amount and intensity) will be controlled.
Control
NO INTERVENTIONno exercise intervention
High amount, high intensity exercise
EXPERIMENTALexercise dose (amount and intensity) will be controlled.
Interventions
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
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
- Robert Ross, PhDlead
Study Sites (1)
School of Kinesiology and Health Studies, Queen's University
Kingston, Ontario, K7L 3N6, Canada
Related Publications (1)
Ross R, Day AG, Stotz PJ, Wade S, Cooke R, Miller E, Liberatore N, Lamarche B. Response variability to exercise (REVISE): Study rationale, design and methods. Contemp Clin Trials Commun. 2025 Jul 5;46:101519. doi: 10.1016/j.conctc.2025.101519. eCollection 2025 Aug.
PMID: 40688055DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Ross, PhD
Queen's University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
September 30, 2022
Primary Completion
September 30, 2025
Study Completion
September 30, 2025
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Within 1 year of study completion.
- Access Criteria
- Deidentified participant data collected during the trial will be available to external groups upon scientific review.
All data will be made available upon request.