Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
38 participants
INTERVENTIONAL
2016-08-31
2020-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
In addition, we have modified the wear time criteria for accelerometry from 600 minutes of wear time to 500 minutes of wear time. This allows for the inclusion of more participant data and more accurately reflects the clinical nature of this population.
Amendment date: 17-Sep-20
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group-Supervised
This intervention arm will include 3 group, supervised sessions per week for 6 months with a certified exercise specialist. Supervised sessions will be delivered in a group format with 4-8 participants per group. Flexibility training will include stretching for 5-10 minutes at the beginning and end of each session. Aerobic training will involve 30 minutes of low-impact step aerobics. Resistance training will be conducted using resistance bands, a stability ball, and an exercise mat with 8 prescribed exercises that target the major muscle groups. Participants will be encouraged to perform exercises independently on additional days, for a total of 4-5 days per week of exercise.
Supervised Group Exercise
The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
Home-Based
The same protocol and training frequency as the supervised programs described above will be followed. However, all exercises will be completed independently by participants. Specific exercises in the aerobic program may be modified to accommodate patient preference (same target heart rate range as the supervised group). Participants will be supported with smartphone technology and remote 'health coaches' during the intervention phase. This will help to ensure participant adherence, appropriate progression, and safety.
Home Based Exercise
The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.
Interventions
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Supervised Group Exercise
The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
Home Based Exercise
The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.
Eligibility Criteria
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Inclusion Criteria
* fluent in English
* able to provide consent
* close to a study centre
Exclusion Criteria
MALE
No
Sponsors
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Tom Baker Cancer Centre
OTHER
Southlake Regional Health Centre
OTHER
Scarborough Rouge Hospital
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Locations
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University of Calgary/Tom Baker Cancer Centre
Calgary, Alberta, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Scarborough and Rouge Hospital
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Alibhai SMH, Papadopoulos E, Mina DS, Ritvo P, Tomlinson G, Sabiston CM, Durbano S, Bremner KE, Chiarotto J, Matthew A, Warde P, O'Neill M, Culos-Reed SN. Home-based versus supervised group exercise in men with prostate cancer on androgen deprivation therapy: A randomized controlled trial and economic analysis. J Geriatr Oncol. 2024 Jan;15(1):101646. doi: 10.1016/j.jgo.2023.101646. Epub 2023 Nov 15.
Alibhai SMH, Ritvo P, Santa Mina D, Sabiston C, Krahn M, Tomlinson G, Matthew A, Lukka H, Warde P, Durbano S, O'Neill M, Culos-Reed SN. Protocol for a phase III RCT and economic analysis of two exercise delivery methods in men with PC on ADT. BMC Cancer. 2018 Oct 23;18(1):1031. doi: 10.1186/s12885-018-4937-x.
Other Identifiers
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14-8158-CE
Identifier Type: -
Identifier Source: org_study_id
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