Response Variability to Exercise

Exercise Clinical Trial

— REVISE  

Official title:

Response Variability to Exercise in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496751
• Other study ID #: Ross2022
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: Queen's University
• Contact: Robert Ross, PhD
• Phone: 613-533-6583
• Email: rossr[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiorespiratory Fitness
• Exercise

Intervention

Behavioral:
• Low amount, low intensity exercise
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
• Low amount, high intensity exercise
Participants will exercise under supervision. Exercise dose will vary by amount and intensity
• High amount, high intensity exercise
Participants will exercise under supervision. Exercise dose will vary by amount and intensity

Locations

Country	Name	City	State
Canada	School of Kinesiology and Health Studies, Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

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