An Exercise Trial and Economic Analysis in Men With Prostate Cancer
NCT ID: NCT02046837
Last Updated: 2021-04-13
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
PHASE2
59 participants
INTERVENTIONAL
2013-11-30
2018-01-31
Brief Summary
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In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based supported; and (c) 1:1 supervised in-centre 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.
The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 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
SUPPORTIVE_CARE
SINGLE
Study Groups
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Supervised 1:1 exercise
This intervention arm will include 3 one-on-one, supervised sessions per week for 6 months with a certified exercise specialist. 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 1:1 exercise
The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.
Supervised group exercise
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 exercise
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 supervised groups). 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 1:1 exercise
The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.
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
* starting or continuing on ADT for at least 6 months
* fluent in English
* able to provide consent
* live close to a study centre
* screened with the Physical Activity Readiness Questionnaire (PAR-Q+ or PARmed-X) to ensure safe exercise participation OR receive medical clearance by attending physician
Exclusion Criteria
* conditions that would interfere with ability to participate
MALE
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Shabbir MH Alibhai, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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University of Calgary/Tom Baker Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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References
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Papadopoulos E, Leach HJ, Tomlinson G, Durbano S, Danyluk JM, Sabiston CM, Mina DS, Alibhai SMH, Culos-Reed SN. Factors predicting gains in moderate-to-vigorous physical activity in prostate cancer survivors on androgen deprivation therapy. Support Care Cancer. 2022 Nov;30(11):9011-9018. doi: 10.1007/s00520-022-07300-2. Epub 2022 Aug 10.
Alibhai SMH, Santa Mina D, Ritvo P, Tomlinson G, Sabiston C, Krahn M, Durbano S, Matthew A, Warde P, O'Neill M, Timilshina N, Segal R, Culos-Reed N. A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2019 Jan 3;19(1):2. doi: 10.1186/s12885-018-5189-5.
Alibhai SM, Santa Mina D, Ritvo P, Sabiston C, Krahn M, Tomlinson G, Matthew A, Segal R, Warde P, Durbano S, O'Neill M, Culos-Reed N. A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2015 Apr 25;15:312. doi: 10.1186/s12885-015-1316-8.
Other Identifiers
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UHN ADT Ex 01
Identifier Type: -
Identifier Source: org_study_id
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