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Clinical Trials/NCT05496751
NCT05496751
Recruiting
Not Applicable

Response Variability to Exercise in Adults

Robert Ross, PhD1 site in 1 country200 target enrollmentSeptember 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise
Sponsor
Robert Ross, PhD
Enrollment
200
Locations
1
Primary Endpoint
Cardiorespiratory Fitness
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2022
End Date
September 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Robert Ross, PhD

Professor

Queen's University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in subcutaneous fat(Measured at baseline, 16 and 32 weeks.)
  • 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)
  • Change in abdominal fat(Measured at baseline, 16 and 32 weeks.)
  • Change in lean body mass(Measured at baseline 16 and 32 weeks.)
  • Change on body weight(Measured at baseline, 16 and 32 weeks.)
  • Change in obesity phenotype(Measured at baseline 16 and 32 weeks.)

Study Sites (1)

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