ExerciseREVISENCT05496751
Response Variability to Exercise
A study testing Low amount, low intensity exercise, Low amount, high intensity exercise and High amount, high intensity exercise in people with Exercise and Cardiorespiratory Fitness, run by Robert Ross, PhD at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Cardiorespiratory Fitness
- What is being tested?
- Low amount, low intensity exercise, Low amount, high intensity exercise and High amount, high intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 30 Sep 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
School of Kinesiology and Health Studies, Queen's University
Kingston, Ontario, K7L 3N6
Robert Ross, PhD, 613-533-6583, rossr@queensu.ca
About this study
Official title: Response Variability to Exercise in Adults
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.
Read the detailed description
The trial has two objectives:
Primary objective: After 16 weeks of first line therapy (150 min/wk of MPA), does increasing exercise intensity or amount for 16 weeks improve cardiorespiratory fitness (CRF, VO2peak) deferentially depending on the CRF response at 16 weeks.
Secondary objective: Determine whether common cardiometabolic risk factors segregate/cluster with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with improvement in CRF.
- Conditions
- Exercise, Cardiorespiratory Fitness
- Being tested
- Low amount, low intensity exercise, Low amount, high intensity exercise, High amount, high intensity exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low amount, low intensity exerciseBehavioural
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
Low amount, high intensity exerciseBehavioural
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
High amount, high intensity exerciseBehavioural
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
| Study group | Role | What they receive |
|---|---|---|
| Low amount, low intensity exercise | Experimental | exercise dose (amount and intensity) will be controlled. Receives: Behavioral: Low amount, low intensity exercise |
| Low amount, high intensity exercise | Experimental | exercise dose (amount and intensity) will be controlled. Receives: Behavioral: Low amount, high intensity exercise |
| Control | No intervention | no exercise intervention |
| High amount, high intensity exercise | Experimental | exercise dose (amount and intensity) will be controlled. Receives: Behavioral: High amount, high intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and every 4 weeks for 32 weeks.
Secondary outcomes (10)
Change in glucose
Fasting glucose (mmol/L)
Measured: Measured at baseline, 16 and 32 weeks.
Change in blood lipids
Fasting LDL- and HDL-cholesterol (mmol/L)
Measured: Measured at baseline, 16 and 32 weeks.]
Change in insulin
fasting insulin (pmol/L)
Measured: Measured at baseline, 16 and 32 weeks.]
Change in triglycerides
fasting triglycerides (mmol/L)
Measured: Measured at baseline, 16 and 32 weeks.
Change in body fat
Total adiposity
Measured: Measured at baseline, 16 and 32 weeks
Change in abdominal fat
Visceral adiposity
Measured: Measured at baseline, 16 and 32 weeks.
Change in lean body mass
Lean mass
Measured: Measured at baseline 16 and 32 weeks.
Change in subcutaneous fat
Subcutaneous adiposity
Measured: Measured at baseline, 16 and 32 weeks.
Change in obesity phenotype
waist circumference
Measured: Measured at baseline 16 and 32 weeks.
Change on body weight
Body weight
Measured: Measured at baseline, 16 and 32 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start30 Sep 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Ross, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Ross, PhD, Queen's University
- Investigators
- Robert Ross, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496751
- Sponsor's protocol ID
- Ross2022
- Acronym
- REVISE
- Status last verified
- Mar 2025
- First submitted
- 9 Aug 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available upon request.
Publications
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.
PubMed 40688055
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Variability to Exercise in Adults
- ClinicalTrials.gov ID
- NCT05496751
- Acronym / sponsor ID
- REVISE / Ross2022
- Conditions
- Exercise, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Robert Ross, PhDUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial has two objectives:
Primary objective: After 16 weeks of first line therapy (150 min/wk of MPA), does increasing exercise intensity or amount for 16 weeks improve cardiorespiratory fitness (CRF, VO2peak) deferentially depending on the CRF response at 16 weeks.
Secondary objective: Determine whether common cardiometabolic risk factors segregate/cluster with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with improvement in CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- randomized trial
| Arm | Type | Receives |
|---|---|---|
| Low amount, low intensity exercise | Experimental | Behavioral: Low amount, low intensity exerciseexercise dose (amount and intensity) will be controlled. |
| Low amount, high intensity exercise | Experimental | Behavioral: Low amount, high intensity exerciseexercise dose (amount and intensity) will be controlled. |
| Control | No intervention | –no exercise intervention |
| High amount, high intensity exercise | Experimental | Behavioral: High amount, high intensity exerciseexercise dose (amount and intensity) will be controlled. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low amount, low intensity exerciseParticipants will exercise under supervision. Exercise dose will vary by amount and intensity | Behavioural | Low amount, low intensity exercise |
| Low amount, high intensity exerciseParticipants will exercise under supervision. Exercise dose will vary by amount and intensity | Behavioural | Low amount, high intensity exercise |
| High amount, high intensity exerciseParticipants will exercise under supervision. Exercise dose will vary by amount and intensity | Behavioural | High amount, high intensity exercise |
Primary outcome
Cardiorespiratory Fitness
Time frame: Measured at baseline and every 4 weeks for 32 weeks.
Cardiorespiratory fitness will be determined using direct (open circuit spirometry) measures of oxygen consumption (expressed in L/min) obtained during a maximal treadmill test.
10 secondary outcomes
Change in glucose
Time frame: Measured at baseline, 16 and 32 weeks.
Change in blood lipids
Time frame: Measured at baseline, 16 and 32 weeks.]
Change in insulin
Time frame: Measured at baseline, 16 and 32 weeks.]
Change in triglycerides
Time frame: Measured at baseline, 16 and 32 weeks.
Change in body fat
Time frame: Measured at baseline, 16 and 32 weeks
Change in abdominal fat
Time frame: Measured at baseline, 16 and 32 weeks.
Change in lean body mass
Time frame: Measured at baseline 16 and 32 weeks.
Change in subcutaneous fat
Time frame: Measured at baseline, 16 and 32 weeks.
Change in obesity phenotype
Time frame: Measured at baseline 16 and 32 weeks.
Change on body weight
Time frame: Measured at baseline, 16 and 32 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 40688055Ross 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.
- Individual participant dataSharing planned: Yes. All data will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Ross, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low amount, low intensity exercise, Low amount, high intensity exercise and High amount, high intensity exercise in people with Exercise and Cardiorespiratory Fitness, run by Robert Ross, PhD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Ross, PhD (613-533-6583, rossr@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Fitness (time frame: Measured at baseline and every 4 weeks for 32 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05496751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.