Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02834416
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2016-06-02
Brief Title:
ADT Exercise Trial and Economic Analysis
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Randomized Control Trial RCT and Economic Analysis of Two Exercise Delivery Methods in Men With Prostate Cancer on ADT
Status:
COMPLETED
Status Verified Date:
2021-04
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:
ADTExRCT
Brief Summary:
Prostate Cancer PC affects 1 in 7 men Nearly half of those diagnosed with PC will receive androgen deprivation therapy ADT as part of their treatment ADT is good at managing PC but has many side effects Researchers have shown that exercise specifically one-on-one supervised exercise improves many of the side effects of ADT However exercise programs for men on ADT are not widely available More questions need to be answered in order for exercise programs to become part of PC treatment First can programs that require fewer resources such as group-exercise or home-based exercise also improve ADT side-effects Second do exercise-related benefits continue beyond the structured exercise program And what makes people continue exercising Third which exercise program is most cost-effective
In this study the investigators will compare a group supervised in-centre and b home-based supported exercise programs to see which program is most effective for men with PC on ADT The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective
Participants men with PC on ADT will be recruited from one of the following cancer centres Princess Margaret Cancer Centre in Toronto the Tom Baker Cancer Centre in Calgary the Southlake Regional Health Centre in Newmarket and Scarborough and Rouge Hospital - Centenary Site in Scarborough When a patient agrees to participate patient will be randomly placed in 1 of 2 exercise programs All programs will include the same type of exercises aerobic resistance and flexibility and all participants will exercise 4-5 days per week for 30 minutes per day as tolerated for the length of the program 6 months The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life QOL fatigue and different physical measures before during and after the exercise program
Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects it is unknown if other forms of exercise are just as beneficial and more financially responsible This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment
In this study the investigators will compare a group supervised in-centre and b home-based supported exercise programs to see which program is most effective for men with PC on ADT The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective
Participants men with PC on ADT will be recruited from one of the following cancer centres Princess Margaret Cancer Centre in Toronto the Tom Baker Cancer Centre in Calgary the Southlake Regional Health Centre in Newmarket and Scarborough and Rouge Hospital - Centenary Site in Scarborough When a patient agrees to participate patient will be randomly placed in 1 of 2 exercise programs All programs will include the same type of exercises aerobic resistance and flexibility and all participants will exercise 4-5 days per week for 30 minutes per day as tolerated for the length of the program 6 months The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life QOL fatigue and different physical measures before during and after the exercise program
Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects it is unknown if other forms of exercise are just as beneficial and more financially responsible This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None