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NCT Number: NCT05496751

Response Variability to Exercise

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Kinesiology and Health Studies, Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location status: Recruiting

Location contact

Robert Ross, PhD

CONTACT

[email protected]

613-533-6583

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low amount, low intensity exercise

Behavioral

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

Low amount, high intensity exercise

Behavioral

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

High amount, high intensity exercise

Behavioral

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

Primary outcomes

  1. Cardiorespiratory Fitness

    Time frame: 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 outcomes

  1. Change in glucose

    Time frame: Measured at baseline, 16 and 32 weeks.

    Fasting glucose (mmol/L)

  2. Change in blood lipids

    Time frame: Measured at baseline, 16 and 32 weeks.]

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

  3. Change in insulin

    Time frame: Measured at baseline, 16 and 32 weeks.]

    fasting insulin (pmol/L)

  4. Change in triglycerides

    Time frame: Measured at baseline, 16 and 32 weeks.

    fasting triglycerides (mmol/L)

  5. Change in body fat

    Time frame: Measured at baseline, 16 and 32 weeks

    Total adiposity

  6. Change in abdominal fat

    Time frame: Measured at baseline, 16 and 32 weeks.

    Visceral adiposity

  7. Change in lean body mass

    Time frame: Measured at baseline 16 and 32 weeks.

    Lean mass

  8. Change in subcutaneous fat

    Time frame: Measured at baseline, 16 and 32 weeks.

    Subcutaneous adiposity

  9. Change in obesity phenotype

    Time frame: Measured at baseline 16 and 32 weeks.

    waist circumference

  10. Change on body weight

    Time frame: Measured at baseline, 16 and 32 weeks.

    Body weight

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Ross, PhD

CONTACT

[email protected]

613-533-6583

Sponsors and collaborators

Lead sponsor

Robert Ross, PhD

Other

Registry information

Official study title

Response Variability to Exercise in Adults

Acronym: REVISE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2022
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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