Response Variability to Exercise

NCT ID: NCT05496751

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-09-30

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.

Conditions

Exercise; Cardiorespiratory Fitness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low amount, low intensity exercise

exercise dose (amount and intensity) will be controlled.

Group Type: EXPERIMENTAL

Low amount, low intensity exercise

Intervention Type: BEHAVIORAL

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

Low amount, high intensity exercise

exercise dose (amount and intensity) will be controlled.

Group Type: EXPERIMENTAL

Low amount, high intensity exercise

Intervention Type: BEHAVIORAL

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

Control

no exercise intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

High amount, high intensity exercise

exercise dose (amount and intensity) will be controlled.

Group Type: EXPERIMENTAL

High amount, high intensity exercise

Intervention Type: BEHAVIORAL

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

Interventions

Low amount, low intensity exercise

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

Intervention Type: BEHAVIORAL

Low amount, high intensity exercise

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

Intervention Type: BEHAVIORAL

High amount, high intensity exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Ross, PhD

OTHER

Sponsor Role: lead

Responsible Party

Robert Ross, PhD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Ross, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

School of Kinesiology and Health Studies, Queen's University

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robert Ross, PhD

Role: CONTACT

rossr@queensu.ca

613-533-6583

Facility Contacts

Robert Ross, PhD

Role: primary

rossr@queensu.ca

613-533-6583

References

Ross R, Day AG, Stotz PJ, Wade S, Cooke R, Miller E, Liberatore N, Lamarche B. Response variability to exercise (REVISE): Study rationale, design and methods. Contemp Clin Trials Commun. 2025 Jul 5;46:101519. doi: 10.1016/j.conctc.2025.101519. eCollection 2025 Aug.

Reference Type: DERIVED

PMID: 40688055 (View on PubMed)

Other Identifiers

Ross2022

Identifier Type: -

Identifier Source: org_study_id