ExerciseNCT04304092
Addressing Individual Variability in Response to Exercise
A study testing Exercise in people with Exercise and Cardiorespiratory Fitness, run by Dr. Robert Ross.
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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Cardiorespiratory Fitness
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- 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.
About this study
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?
Read the detailed description
The trial has three objectives:
Primary objective: Determine whether alterations in exercise amount and intensity improves the rate of clinically meaningful improvements in aerobic exercise capacity as measured by cardiorespiratory fitness (CRF, VO2peak) among adults.
Secondary objective: Determine whether common cardiometabolic risk factors segregate with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with associated improvement in CRF.
Tertiary objective: Identify whether biological sex and/or phenotype are determinants of variation in CRF and cardiometabolic risk factors in response to first line therapy, and, whether they predict variability in CRF response to alterations in exercise dose.
- Conditions
- Exercise, Cardiorespiratory Fitness
- Being tested
- 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.
ExerciseOther
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
| Study group | Role | What they receive |
|---|---|---|
| Low amount, low intensity | Experimental | Not described Receives: Other: Exercise |
| Low amount, high intensity | Experimental | Not described Receives: Other: Exercise |
| High Amount, low intensity | Experimental | Not described Receives: Other: Exercise |
| High Amount, high intensity | Experimental | Not described Receives: Other: Exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and every 4 weeks for 32 weeks.
Secondary outcomes (4)
Change in cardiometabolic risk factors
Fasting glucose (mmol/L)
Measured: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
Fasting LDL- and HDL-cholesterol (mmol/L)
Measured: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
fasting insulin (pmol/L)
Measured: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factor
fasting triglycerides (mmol/L)
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 Mar 2020
- Study start1 Jan 2022 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Robert Ross
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Dr. Robert Ross, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304092
- Sponsor's protocol ID
- Ross2019
- Status last verified
- Sep 2021
- First submitted
- 28 Feb 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Individual Variability in Response to Exercise
- ClinicalTrials.gov ID
- NCT04304092
- Acronym / sponsor ID
- Ross2019
- Conditions
- Exercise, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Robert RossUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 11 Mar 2020 (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 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?
Detailed description
The trial has three objectives:
Primary objective: Determine whether alterations in exercise amount and intensity improves the rate of clinically meaningful improvements in aerobic exercise capacity as measured by cardiorespiratory fitness (CRF, VO2peak) among adults.
Secondary objective: Determine whether common cardiometabolic risk factors segregate with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with associated improvement in CRF.
Tertiary objective: Identify whether biological sex and/or phenotype are determinants of variation in CRF and cardiometabolic risk factors in response to first line therapy, and, whether they predict variability in CRF response to alterations in exercise dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low amount, low intensity | Experimental | Other: Exercise |
| Low amount, high intensity | Experimental | Other: Exercise |
| High Amount, low intensity | Experimental | Other: Exercise |
| High Amount, high intensity | Experimental | Other: Exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| ExerciseParticipants will exercise under supervision. Exercise dose will vary by amount and intensity | Other | High Amount, high intensity, High Amount, low intensity, Low amount, high intensity, Low amount, low intensity |
Primary outcome
Change in 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.
4 secondary outcomes
Change in cardiometabolic risk factors
Time frame: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
Time frame: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factors
Time frame: Measured at baseline, 16 and 32 weeks.
Change in cardiometabolic risk factor
Time frame: Measured at baseline, 16 and 32 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise and Cardiorespiratory Fitness, run by Dr. Robert Ross.
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: withdrawn, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 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?
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 22 Jun 2022.