Response Variability to Exercise (REVISE)

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Cardiorespiratory Fitness
• Intervention / Treatment: Behavioral: Low amount, low intensity exercise; Behavioral: Low amount, high intensity exercise; Behavioral: High amount, high intensity exercise

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Ross, PhD; Phone Number: 613-533-6583; Email: rossr@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Recruiting
      • School of Kinesiology and Health Studies, Queen's University
      • Contact: Robert Ross, PhD; Phone Number: 613-533-6583; Email: rossr@queensu.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low amount, low intensity exercise; exercise dose (amount and intensity) will be controlled.	Behavioral: Low amount, low intensity exercise; Participants will exercise under supervision. Exercise dose will vary by amount and intensity
Experimental: Low amount, high intensity exercise; exercise dose (amount and intensity) will be controlled.	Behavioral: Low amount, high intensity exercise; Participants will exercise under supervision. Exercise dose will vary by amount and intensity
No Intervention: Control; no exercise intervention
Experimental: High amount, high intensity exercise; exercise dose (amount and intensity) will be controlled.	Behavioral: High amount, high intensity exercise; Participants will exercise under supervision. Exercise dose will vary by amount and intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in glucose	Fasting glucose (mmol/L)	Measured at baseline, 16 and 32 weeks.
Change in blood lipids	Fasting LDL- and HDL-cholesterol (mmol/L)	Measured at baseline, 16 and 32 weeks.]
Change in insulin	fasting insulin (pmol/L)	Measured at baseline, 16 and 32 weeks.]
Change in triglycerides	fasting triglycerides (mmol/L)	Measured at baseline, 16 and 32 weeks.
Change in body fat	Total adiposity	Measured at baseline, 16 and 32 weeks
Change in abdominal fat	Visceral adiposity	Measured at baseline, 16 and 32 weeks.
Change in lean body mass	Lean mass	Measured at baseline 16 and 32 weeks.
Change in subcutaneous fat	Subcutaneous adiposity	Measured at baseline, 16 and 32 weeks.
Change in obesity phenotype	waist circumference	Measured at baseline 16 and 32 weeks.
Change on body weight	Body weight	Measured at baseline, 16 and 32 weeks.

Collaborators and Investigators

• Sponsor: Robert Ross, PhD
• Investigators: Principal Investigator: Robert Ross, PhD, Kingston Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Ross2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be made available upon request.
• IPD Sharing Time Frame: Within 1 year of study completion.
• IPD Sharing Access Criteria: Deidentified participant data collected during the trial will be available to external groups upon scientific review.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No