NCT05496751

Response Variability to Exercise

Response Variability to Exercise in Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Robert Ross, PhD · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Exercise
• Cardiorespiratory Fitness

Interventions

Type	Name	Description
BEHAVIORAL	Low amount, low intensity exercise	Participants will exercise under supervision. Exercise dose will vary by amount and intensity
BEHAVIORAL	Low amount, high intensity exercise	Participants will exercise under supervision. Exercise dose will vary by amount and intensity
BEHAVIORAL	High amount, high intensity exercise	Participants will exercise under supervision. Exercise dose will vary by amount and intensity

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2022-08-11
• Last updated: 2025-03-20

Locations

1 site across 1 country: Canada