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A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

ABSTRACT: BACKGROUND:Existing evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOME compared to PT on quality of life (QOL) and physical fitness. METHODS:Men with prostate cancer on ADT were recruited from one of two experienced Canadian centres and randomized 1:1:1 to PT, GROUP, or HOME. Randomization was stratified by length of ADT use and site. Participants completed moderate intensity aerobic and resistance exercises 4-5?days per week for 6 months with a target 150?min per week of exercise. Exercise prescriptions were individualized and progressed throughout the trial. Feasibility endpoints included recruitment, retention, adherence, and participant satisfaction. The efficacy endpoints QOL, fatigue, and fitness (VO2 peak, grip strength, and timed chair stands) in GROUP and HOME were compared for non-inferiority to PT. Descriptive analyses were used for feasibility endpoints. Between-group differences for efficacy endpoints were examined using Bayesian linear mixed effects models. RESULTS:Fifty-nine participants (mean age 69.9?years) were enrolled. The recruitment rate was 25.4% and recruitment was slower than projected. Retention was 71.2%. Exercise adherence as measured through attendance was high for supervised sessions but under 50% by self-report and accelerometry. Satisfaction was high and there was no difference in this measure between all three groups. Between-group differences (comparing both GROUP and HOME to PT) were smaller than the minimum clinically important difference on most measures of QOL, fatigue, and fitness. However, two of six outcomes for GROUP and four of six outcomes for HOME had a?>?20% probability of being inferior for GROUP. CONCLUSIONS:Feasibility endpoints were generally met. Both GROUP and HOME interventions in men with PC on ADT appeared to be similar to PT for multiple efficacy outcomes, although conclusions are limited by a small sample size and cost considerations have not been incorporated. Efforts need to be targeted to improving recruitment and adherence. A larger trial is warranted. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02046837 . Date of registration: January 20, 2014.

SUBMITTER: Alibhai SMH

PROVIDER: S-EPMC6318980 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

Alibhai Shabbir M H SMH Santa Mina Daniel D Ritvo Paul P Tomlinson George G Sabiston Catherine C Krahn Murray M Durbano Sara S Matthew Andrew A Warde Padraig P O'Neill Meagan M Timilshina Narhari N Segal Roanne R Culos-Reed Nicole N

BMC cancer 20190103 1

<h4>Background</h4>Existing evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOM ...[more]

PMID: 30606137

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Project description:BackgroundAndrogen deprivation therapy is commonly used to treat prostate cancer, the most common visceral cancer in men. However, various side effects often worsen physical functioning and reduce well-being among men on this treatment. Based on existing evidence, both resistance and aerobic training provide benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-center or home-based) may be important, yet few studies have compared different models. Additionally, long-term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors of adherence are lacking. The primary aim of this phase II, non-inferiority randomized controlled trial is to determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-effectiveness.DesignMen diagnosed with prostate cancer, starting or continuing on androgen deprivation therapy for at least 6 months, fluent in English, and living close to one of two experienced Canadian study centers are eligible. Participants complete five assessments over one year, including a fitness assessment and self-report questionnaires. Socio-demographic and clinical data collection occur at baseline, bone mineral density testing at two time points, and blood work is performed at three time points. Participants are randomized in a 1:1:1 fashion to supervised personal training, supervised group training, or home-based smartphone- and health coach-supported training. Each participant receives a detailed exercise manual, including illustrations of exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week, incorporating aerobic, resistance and flexibility training. Participant intensity levels will be monitored. The intervention duration is 6 months, with 6 months additional follow-up. Outcomes include: body composition, fitness testing, quality of life and fatigue, biological outcomes, and program adherence. Cost information will be obtained using patient diary-based self-report.DiscussionThe goals of this study are to gain a better understanding of health benefits and costs associated with commonly used yet currently not compared exercise delivery models as well as an increased understanding of adherence to exercise.Trial registrationThe trial has been registered at clinicaltrials.gov (Registration # NCT02046837), registered January 20(th), 2014.

Project description:BackgroundAndrogen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT.Methods/designA 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data.DiscussionMusculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.Trial registrationClinicalTrials.gov: NCT00834392.

Project description:Interventions: Men with prostate cancer receiving androgen deprivation therapy will attend three clinic-based supervised exercise sessions each week, for 12 weeks (3 months), consisting of moderate-to-high intensity resistance and aerobic exercise (interval and continuous). Each session will take approximately 60 minutes, including warm-up and cool-down, and will be supervised by accredited exercise physiologists (AEP; Exercise and Sport Science Australia, Brisbane, Australia), face-to-face (in groups of up to 8 people per session). The exercise program is designed to provide optimal stimulus to the cardiorespiratory and neuromuscular systems while maximising safety, compliance and retention, thus will be tailored, progressive, periodised and autoregulated in collaboration with the patient (i.e. adjusted based on the patient’s presentation at each session). Resistance exercise will be prescribed using repetition maximums (RM), where patients will be required to perform 6-8 different resistance exercises using major muscle groups, at 6-12 RM (the maximal weight that can be lifted 6 to 12 times each set, equivalent to ~60-85% of 1RM) for 3-4 sets per exercise to achieve moderate-to-high intensity and volume. Aerobic exercise will include 20 to 30 minutes of moderate-to-vigorous intensity activity (equating to ~60-85% of estimated maximum heart rate; or a rating of perceived exertion (RPE) between 6-9 using the BORG-10 scale) involving a variety of modes including walking, jogging, cycling or rowing, using treadmills and/or stationary ergometers respectively. Aerobic intensity will be monitored using heart rate monitors (Polar M400, H10 Sensor, Polar Electro, NSW, Australia) and an RPE chart for assessment. Patients will also be encouraged to perform additional aerobic exercise Primary outcome(s): Microbiome Behaviour/DNA/Composition Gut Health and Function will be assessed through the provision of a 24-hour collection of stool sample(s); subsequently examined/analysed for microbiome behaviour/DNA/composition. The 24-hour collection of fecal samples will also be collected for comprehensive metabolomics analysis.[Week 0 (baseline) and Week 13 (post-intervention).];Fecal Calprotectin An analysis of fecal calprotectin analysis will be provided analysis also provided as an indicator of Gut Health and Function.[Week 0 (baseline) and Week 13 (post-intervention)] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy

Project description:ContextDespite a lack of data, increasing numbers of patients are receiving primary androgen deprivation therapy (PADT) as an alternative to surgery, radiation, or conservative management for the treatment of localized prostate cancer.ObjectiveTo evaluate the association between PADT and survival in elderly men with localized prostate cancer.Design, setting, and patientsA population-based cohort study of 19,271 men aged 66 years or older receiving Medicare who did not receive definitive local therapy for clinical stage T1-T2 prostate cancer. These patients were diagnosed in 1992-2002 within predefined US geographical areas, with follow-up through December 31, 2006, for all-cause mortality and through December 31, 2004, for prostate cancer-specific mortality. Instrumental variable analysis was used to address potential biases associated with unmeasured confounding variables.Main outcome measuresProstate cancer-specific survival and overall survival.ResultsAmong patients with localized prostate cancer (median age, 77 years), 7867 (41%) received PADT, and 11,404 were treated with conservative management, not including PADT. During the follow-up period, there were 1560 prostate cancer deaths and 11,045 deaths from all causes. Primary androgen deprivation therapy was associated with lower 10-year prostate cancer-specific survival (80.1% vs 82.6%; hazard ratio [HR], 1.17; 95% confidence interval [CI], 1.03-1.33) and no increase in 10-year overall survival (30.2% vs 30.3%; HR, 1.00; 95% CI, 0.96-1.05) compared with conservative management. However, in a prespecified subset analysis, PADT use in men with poorly differentiated cancer was associated with improved prostate cancer-specific survival (59.8% vs 54.3%; HR, 0.84; 95% CI, 0.70-1.00; P = .049) but not overall survival (17.3% vs 15.3%; HR, 0.92; 95% CI, 0.84-1.01).ConclusionPrimary androgen deprivation therapy is not associated with improved survival among the majority of elderly men with localized prostate cancer when compared with conservative management.

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A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

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A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

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