Response Variability to Exercise

Official title

Response Variability to Exercise in Adults

Overview

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.

Interventions

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

Primary outcome measures

• Cardiorespiratory Fitness [Time frame: Measured at baseline and every 4 weeks for 32 weeks.]

Secondary outcome measures (10)

• Change in glucose [Time frame: Measured at baseline, 16 and 32 weeks.]
• Change in blood lipids [Time frame: Measured at baseline, 16 and 32 weeks.]]
• Change in insulin [Time frame: Measured at baseline, 16 and 32 weeks.]]
• Change in triglycerides [Time frame: Measured at baseline, 16 and 32 weeks.]
• Change in body fat [Time frame: Measured at baseline, 16 and 32 weeks]
• Change in abdominal fat [Time frame: Measured at baseline, 16 and 32 weeks.]
• Change in lean body mass [Time frame: Measured at baseline 16 and 32 weeks.]
• Change in subcutaneous fat [Time frame: Measured at baseline, 16 and 32 weeks.]
• Change in obesity phenotype [Time frame: Measured at baseline 16 and 32 weeks.]
• Change on body weight [Time frame: Measured at baseline, 16 and 32 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• School of Kinesiology and Health Studies, Queen's University — Kingston

Publications

• 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. PMID 40688055

Identifiers

NCT: NCT05496751 · Ross2022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗