Clinical trial NCT05496751: Response Variability to Exercise
Official title: Response Variability to Exercise in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise
Cardiorespiratory Fitness
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Measured at baseline and every 4 weeks for 32 weeks.
Secondary outcomes:
measure: Change in glucose
timeFrame: Measured at baseline, 16 and 32 weeks.
measure: Change in blood lipids
timeFrame: Measured at baseline, 16 and 32 weeks.]
measure: Change in insulin
timeFrame: Measured at baseline, 16 and 32 weeks.]
measure: Change in triglycerides
timeFrame: Measured at baseline, 16 and 32 weeks.
measure: Change in body fat
timeFrame: Measured at baseline, 16 and 32 weeks
measure: Change in abdominal fat
timeFrame: Measured at baseline, 16 and 32 weeks.
measure: Change in lean body mass
timeFrame: Measured at baseline 16 and 32 weeks.
measure: Change in subcutaneous fat
timeFrame: Measured at baseline, 16 and 32 weeks.
measure: Change in obesity phenotype
timeFrame: Measured at baseline 16 and 32 weeks.
measure: Change on body weight
timeFrame: Measured at baseline, 16 and 32 weeks.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: School of Kinesiology and Health Studies, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References: