Individual Variability in Response to Exercise in Adults

Sponsor
Queen's University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05496751
Collaborator
(none)
200
3
48

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 increasing exercise 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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Low amount, low intensity exercise
  • Behavioral: Low amount, high intensity exercise
N/A

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized trialrandomized trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Individual Response to Exercise
Anticipated Study Start Date :
Sep 10, 2022
Anticipated Primary Completion Date :
Sep 10, 2025
Anticipated Study Completion Date :
Sep 10, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low amount, low intensity exercise

exercise dose (amount and intensity) will be controlled.

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

Experimental: Low amount, high intensity exercise

exercise dose (amount and intensity) will be controlled.

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

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. 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)

  5. Change in body composition [Measured at baseline, 16 and 32 weeks]

    Total adiposity

  6. Change in body composition [Measured at baseline, 16 and 32 weeks.]

    Visceral adiposity

  7. Change in body composition [Measured at baseline 16 and 32 weeks.]

    Lean mass

  8. Change in body composition [Measured at baseline, 16 and 32 weeks.]

    Subcutaneous adiposity

  9. Change in obesity phenotype [Measured at baseline 16 and 32 weeks.]

    waist circumference

  10. Change on body weight [Measured at baseline, 16 and 32 weeks.]

    Body weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 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

  • Queen's University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Robert Ross, PhD, Professor, Queen's University
ClinicalTrials.gov Identifier:
NCT05496751
Other Study ID Numbers:
  • Ross2022
First Posted:
Aug 11, 2022
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Aug 11, 2022