Addressing Individual Variability in Response to Exercise

Sponsor
Dr. Robert Ross (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04304092
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
0
5
51

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
exercise trial, no blinding
Primary Purpose:
Treatment
Official Title:
Addressing Individual Variability in Response to Exercise
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low amount, low intensity

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

Experimental: Low amount, high intensity

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

Experimental: High Amount, low intensity

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

Experimental: High Amount, high intensity

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Change in Cardiorespiratory Fitness [Measured at baseline and every 4 weeks for 32 weeks.]

    Cardiorespiratory fitness will be determined using direct (open circuit spirometry) measures of oxygen consumption (expressed in L/min) obtained during a maximal treadmill test.

Secondary Outcome Measures

  1. Change in cardiometabolic risk factors [Measured at baseline, 16 and 32 weeks.]

    Fasting glucose (mmol/L)

  2. Change in cardiometabolic risk factors [Measured at baseline, 16 and 32 weeks.]

    Fasting LDL- and HDL-cholesterol (mmol/L)

  3. Change in cardiometabolic risk factors [Measured at baseline, 16 and 32 weeks.]

    fasting insulin (pmol/L)

  4. Change in cardiometabolic risk factor [Measured at baseline, 16 and 32 weeks.]

    fasting triglycerides (mmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dr. Robert Ross
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Robert Ross, Professor, Queen's University
ClinicalTrials.gov Identifier:
NCT04304092
Other Study ID Numbers:
  • Ross2019
First Posted:
Mar 11, 2020
Last Update Posted:
Jun 22, 2022
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 22, 2022