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Response Variability to Exercise

Response Variability to Exercise in Adults

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05496751
Acronym
REVISE
Enrollment
200
Registered
2022-08-11
Start date
2022-09-30
Completion date
2025-09-30
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiorespiratory Fitness, Exercise

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.

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.

Interventions

BEHAVIORALLow amount, low intensity exercise

Participants will exercise under supervision. Exercise dose will vary by amount and intensity

BEHAVIORALLow amount, high intensity exercise

Participants will exercise under supervision. Exercise dose will vary by amount and intensity

BEHAVIORALHigh amount, high intensity exercise

Participants will exercise under supervision. Exercise dose will vary by amount and intensity

Sponsors

Robert Ross, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomized trial

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiorespiratory FitnessMeasured 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.

Secondary

MeasureTime frameDescription
Change in blood lipidsMeasured at baseline, 16 and 32 weeks.]Fasting LDL- and HDL-cholesterol (mmol/L)
Change in insulinMeasured at baseline, 16 and 32 weeks.]fasting insulin (pmol/L)
Change in triglyceridesMeasured at baseline, 16 and 32 weeks.fasting triglycerides (mmol/L)
Change in body fatMeasured at baseline, 16 and 32 weeksTotal adiposity
Change in glucoseMeasured at baseline, 16 and 32 weeks.Fasting glucose (mmol/L)
Change in lean body massMeasured at baseline 16 and 32 weeks.Lean mass
Change in subcutaneous fatMeasured at baseline, 16 and 32 weeks.Subcutaneous adiposity
Change in obesity phenotypeMeasured at baseline 16 and 32 weeks.waist circumference
Change on body weightMeasured at baseline, 16 and 32 weeks.Body weight
Change in abdominal fatMeasured at baseline, 16 and 32 weeks.Visceral adiposity

Countries

Canada

Contacts

Primary ContactRobert Ross, PhD
rossr@queensu.ca613-533-6583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026