Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments supervised 1:1 exercise, supervised group exercise, home-based exercise
Phase phase 2
Sponsor University Health Network, Toronto
Start date November 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT02046837, UHN ADT Ex 01

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; (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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
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.
(Experimental)
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.
(Experimental)
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.

Primary Outcomes

Measure
Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year

Secondary Outcomes

Measure
Change from baseline in quality of life (QOL) at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in fatigue at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in aerobic fitness (VO2peak) at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in musculoskeletal fitness at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in grip strength at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in body composition at 6 and 12 months
time frame: Every 6 months for 1 year
Change from baseline in bone mineral density at 12 months
time frame: Baseline and 1 year.
Change from baseline in biological outcomes at 6 and 12 months
time frame: Every 6 months for 1 year
Change from baseline in adherence predictors at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year
Change from baseline in cost-effectiveness at 3, 6, 9, and 12 months
time frame: Every 3 months for 1 year

Eligibility Criteria

Male participants of any age.

Inclusion Criteria: - confirmed prostate cancer - 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: - already meeting guidelines for moderate to vigorous physical activity (MVPA) as defined by the Canadian Physical Activity Guidelines (greater than or equal to 150 minutes of MVPA per week) - conditions that would interfere with ability to participate

Additional Information

Official title A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT
Principal investigator Shabbir MH Alibhai, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.