None listed
Conditions
Brief summary
This study aims to investigate the effects of a targeted exercise program on muscle function in men with non-metastatic prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible to join this study if you are a male aged 50-80 years with non-localised non-metastatic prostate cancer, and are about to commence androgen deprivation therapy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive routine recommendations for healthy lifestyle. Participants in the other group will undertake an exercise program which will be home-based and administered by an exercise physiologist The exercise physiologist will design a program tailored to each participant to strengthen lower limb muscles.. After 12 months all participants will undertake physical testing to evaluate any effects of the exercise program. They will also be asked to complete a questionnaire evaluating quality of life. It is hoped that the exercise program will help to prevent muscle loss, which is a major adverse effect of ADT.
Interventions
Participants will be individually randomised to an intervention group (exercise and standard care) or a control group (standard care alone) in a 1:1 ratio according to a computer generated randomisation procedure performed by a third party
Intervention arms: exercise and standard care/ standard care alone
Standard care will involve general lifestyle education for prostate cancer and encouragement to be physically active, in accordance with Australia’s Physical Activity and Sedentary Behaviour G
Participants will be individually randomised to an intervention group (exercise and standard care) or a control group (standard care alone) in a 1:1 ratio according to a computer generated randomisation procedure performed by a third party Intervention arms: exercise and standard care/ standard care alone Standard care will involve general lifestyle education for prostate cancer and encouragement to be physically active, in accordance with Australia’s Physical Activity and Sedentary Behaviour Guidelines These include written recommendation to participate in 150-300 mins of moderate activity per week and strength training twice per week (available at http://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-phys-act-guidelines).. Those in the intervention arm will, in addition, be provided with an individualised, home-based functional lower limb-strengthening program. This individualised exercise program will be developed at study entry in the department of physiotherapy at Austin Health. This initial visit will take 90 min. Individualised means that exercise will be tailored to each individual. It is difficult to describe this im detail but in principle, the physiotherapist will assess which muscles are the weakest and provide the participant with a written exercise program accordingly, with clear instructions. The program will focus on muscles utilised in walking and balance, specifically hip flexors, extensors and abductors, knee extensors and plantarflexors. Exercises will replicate the way muscles are used during walking, with respect to joint position, type of contraction and speed of movement. For example, hip flexors will be strengthened with the hip in an extended position with an emphasis on a fast concentric contraction. Simple equipment such as theraband and cuff weights will be used in conjunction with body weight to provide resistance. Participants will be instructed to perform one to two sets of each exercise, with each set comprising 10 – 15 repetitions at 50 – 70% of 1RM (Repetition Maximum). This exercise program will be performed twice a week and duration is 30 min. The exercise physiologist will monitor compliance during 5 face to face sessions in the participant’s place of residence (weeks 1, 4, 13, 26, 39) and 5 phone sessions (weeks 2, 9, 19, 32). The sessions at home will take 45 min and the phone sessions 10 min per session. The intervention period will be 12 months.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
ADT naive men with localised non-metastatic prostate cancer (T1-3NxM0), age 50-80 years about to commence treatment with GnRH agonists to suppress androgen production, in whom treatment with ADT is intended for at least 12 months, who live independently in the community, and are ambulant, fully active, and unrestricted in their physical activities.
Exclusion criteria
1) Impaired performance status (ECOG < 1), neuromuscular disease, or requiring a walking aid. 2) Evidence of androgen deficiency or baseline serum total T <10nmol/L. 3) Active cardiac, respiratory or joint disease affecting exercise tolerance or muscle function. 4) Corticosteroid or recreational drug use, alcohol dependence or any disease likely to lead to serious illness or death within the study period. 5) Participated in a regular strength training program (2 or more times per week for more than 6 weeks) in the last 12 months.
Outcome results
None listed