None listed
Conditions
Brief summary
The primary purpose of this study is to determine the feasibility and efficacy of an exercise program to ameliorate the primary physical and mental health problems faced by men on prostate cancer active surveillance and to explore potential mechanisms underlying the influence of phsical exercise on markers of disease progression. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer in the previous year, currently undergoing active surveillance. Study details Participants will be randomly allocated (by chance) to receive either the exercise program or usual care. Participants in the exercise program group will receive supervised resistance and aerobic exercise sessions, each lasting approximately one hour, three times per week for six months. These participants will also be encouraged to complete additional aerobic exercise at home to create a total of 150 minutes of moderate aerobic exercise per week. Participants allocated to receive usual care will be encouraged to complete a walking program and will be given an information booklet detailing the current national aerobic exercise recommendations for cancer survivors along with a log-book to record their physical activity. The aim will be to complete a total of 150 minutes of aerobic exercise per week by month 6. Patient outcomes will then be assessed through blood samples, fitness tests and questionnaires at 3 months and 6 months. It is hoped that the findings of this trial will provide information regarding the feasibility of implementing an exercise intervention for prostate cancer patients on active surveillance, as well as the efficacy of such a program on mental and physical health outcomes, as well as on disease progression.
Interventions
Intervention group: Supervised resistance and aerobic exercise performed over 3 sessions per week (approx. 60 min per session) for 6 months. Resistance exercise involves 6-8 exercises that target the major upper and lower body muscle groups. Intensity is manipulated from 6-12 repetition maximum using 1-4 sets per exercise. The aerobic exercise component includes 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of
Intervention group: Supervised resistance and aerobic exercise performed over 3 sessions per week (approx. 60 min per session) for 6 months. Resistance exercise involves 6-8 exercises that target the major upper and lower body muscle groups. Intensity is manipulated from 6-12 repetition maximum using 1-4 sets per exercise. The aerobic exercise component includes 20 to 30 minutes of moderate to vigorous intensity cardiovascular exercise (~60-85% of estimated maximum heart rate) using a variety of modes such as walking or jogging on a treadmill, cycling or rowing on a stationary ergometer. The exercise sessions are conducted in small groups and under direct supervision by an accredited exercise physiologist. Participants are encouraged to undertake additional aerobic exercise outside the clinic sessions with the goal of achieving a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Exercise adherence is assessed by register of attendance at the exercise sessions and exercise diary for home exercises. Usual care group: Unsupervised walking program and an educational booklet outlining the current national aerobic exercise recommendations for cancer survivors along with a log-book to record the physical activity. Patients are encouraged to achieving a total of at least 150 minutes of aerobic exercise per week by month 6.
Sponsors
Edith Cowan University Exercise Medicine Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Be within 1 year of diagnosis of prostate cancer (clinical state as T1C and T2, Gleason score smaller than or equal to 6 (or as determined by treating clinician) and under 3 biopsy cores invaded with prostate cancer, PSA < 10ng/ml and PSA density < .2ng/ml) and undergoing active surveillance 2) Have physician consent 3) Willing to be randomised 4) Able to read and understand English
Exclusion criteria
1) Received former therapy for prostate cancer 2) Not fit for curative treatment 3) Already performing regular exercise defined as undertaking structured resistance and aerobic training two or more times per week within the past 3 months 4) Any acute illness, musculoskeletal, cardiovascular or neurological disorder that could inhibit a participant's ability to participate in the exercise program or put them at risk of injury or illness.
Outcome results
None listed