Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454864
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-22
Brief Title:
Multiple Risk Factor Intervention Trial in Breast Cancer Survivors
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Multiple Risk Factor Intervention Trial In Breast Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MsFITBC
Brief Summary:
This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors Using a 3-arm RCT with to 6 months of 1 exercise following Health Canada guidelines 2 the same exercise plus counselling to follow Canadas Dietary Guidelines to improve diet quality or 3 stretching group this study will answer the following questions
What is the impact of exercise on cardiometabolic health and body composition in BC survivors
What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition
Is there a link between the capacity of skeletal muscle adaptation to exercise and diet and insulin resistance in BC survivors
The investigators hypothesize that 1 exercise will improve cardiometabolic and body composition outcomes 2 improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality which will be essential or additive for Matsuda index metabolic syndrome Framingham CVD risk thigh myosteatosis muscle mass VO2peak 3 skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins eg GLUT4 and co-occur with impaired muscle quality eg higher rates of fat depots presence of fibrous tissue negatively impacting insulin signalling
What is the impact of exercise on cardiometabolic health and body composition in BC survivors
What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition
Is there a link between the capacity of skeletal muscle adaptation to exercise and diet and insulin resistance in BC survivors
The investigators hypothesize that 1 exercise will improve cardiometabolic and body composition outcomes 2 improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality which will be essential or additive for Matsuda index metabolic syndrome Framingham CVD risk thigh myosteatosis muscle mass VO2peak 3 skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins eg GLUT4 and co-occur with impaired muscle quality eg higher rates of fat depots presence of fibrous tissue negatively impacting insulin signalling
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None