Addressing Individual Variability in Response to Exercise

NCT ID: NCT04304092

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-04-01

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 exercise amount or intensity, 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 amount or intensity 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. 4) To what extent is biological sex and/or phenotype a determinant of response or non-response to exercise?

Detailed Description

The trial has three objectives:

Primary objective: Determine whether alterations in exercise amount and intensity improves the rate of clinically meaningful improvements in aerobic exercise capacity as measured by cardiorespiratory fitness (CRF, VO2peak) among adults.

Secondary objective: Determine whether common cardiometabolic risk factors segregate with respect to variation in CRF to first line therapy in adults, and, whether clinically meaningful improvements in cardiometabolic risk factors segregate with associated improvement in CRF.

Tertiary objective: Identify whether biological sex and/or phenotype are determinants of variation in CRF and cardiometabolic risk factors in response to first line therapy, and, whether they predict variability in CRF response to alterations in exercise dose.

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Low amount, high intensity

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

High Amount, low intensity

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

High Amount, high intensity

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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

Intervention Type: OTHER

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: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Dr. Robert Ross

OTHER

Sponsor Role: lead

Responsible Party

Dr. Robert Ross

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Ross2019

Identifier Type: -

Identifier Source: org_study_id