Culos-Reed, S. N., Robinson, J. W., Lau, H., Stephenson, L., Keats, M., Norris, S., . . . Faris, P. (2010). Physical activity for men receiving androgen deprivation therapy for prostate cancer: benefits from a 16-week intervention. Supportive Care in Cancer, 18, 591–599.

To investigate the effects of a physical activity intervention for men receiving androgen deprivation therapy (ADT) on physical activity behavior, quality of life (QOL), and fitness.

Patients were randomly assigned to either the intervention or a wait-list control group. Assessments were performed in both groups at baseline, after completion of the 16-week activity intervention, and two and six months postintervention. The exercise program included a home-based portion and weekly group sessions of an individualized program provided by a certified fitness professional. Exercises were tailored to ability but consisted mostly of walking, stretching, and resistance exercises with a Thera-Band. A physioball and Thera-Band were provided to each patient for use in the home-based activity. Home exercise was suggested three to five times per week. Group sessions were conducted weekly for 16 weeks and monthly thereafter until completion of all follow-up measures. These included a group-based workout with individualized feedback, education, and group discussion. Discussion focused on common concerns, goal setting, monitoring behavior, overcoming barriers, role of a positive attitude, social support, relapse prevention, and nutrition.

• One hundred patients were randomized, and 66 completed the study.
• Mean age was 67.6 years (standard deviation = 8.6 years). 
• Patients had any stage of prostate cancer and were expected to receive ADT for at least six months.
• Patients with a high risk of osteoporosis were excluded (long-term steroid use or a T-score less than –2.5 on bone mineral densitometry).
• Of the patients, 88% were married and 61% were retired.
• Patients were recruited between 2004 and 2006 and had physician clearance to participate in the exercise program.

• Single site
• Calgary, Canada

The study used a randomized, controlled, repeated measures design.

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Expanded Prostate Cancer Index Composite (EPIC):  This instrument assesses function and bother in three organ systems:  sexual, urinary, and bowel, and has recently expanded to include possible effects of ADT. The test retest reliability and internal consistency is reported to be high for the urinary, bowel, sexual, and hormonal domain summary scores (r ≥ 0.80; α ≥ 0.82).
• Fatigue Severity Scale (FSS)
• Center for Epidemiologic Studies Depression scale (CESD)
• Godins’ leasure score index (LSI) of Godin’s leisure time exercise questionnaire:  a three-item measure assessment of frequency of exercise
• Fitness assessment, including resting heart rate, blood pressure, six-minute walk, grip dynamometer, and flexibility by testing modified sit and reach
• Body mass index (BMI)
• Baseline bone densitometry
• Variety of bloodwork

• Of the patients, 34% dropped out.
• LSI scores pre- to postintervention showed a significant interaction effect (p = 0.004) with the intervention group reporting increased physical activity and the controls reporting decreased levels.
• No significant changes were seen in QOL measurements.
• Of the patients who dropped out, 67% were in the wait-list control group. In the intervention group, 10 patients withdrew; five of these withdrew for medical reasons.
• Attendance for group sessions was 77.8%, with attendance on average at 12 of 16 sessions.
• At baseline, both groups had similar BMI measures and were considered in the overweight category. After the program, the intervention group had a very slight decrease in average BMI (change of –0.23), whereas the controls showed an average increase to 29.04 (change of 0.75), just below the level that differentiates overweight from obesity.
• In the intervention group, there were nonsignificant improvements seen in depression over time; however, the intervention group had a higher level of depression at baseline than the control group.
• There were no significant changes in fatigue scores over time or between groups.

The physical activity intervention was associated with an overall increase in reported physical activity. There were no significant effects seen in QOL or fatigue.

• The high drop-out rate reduced the statistical power of the study, which may have resulted in an inability to detect significant differences between groups.
• No mechanism was used to evaluate patient adherence to the home-based part of the program.
• The study lacked an attentional control.
• There may have been sample selection bias because individuals interested in or already having a more active lifestyle may be more likely to participate in this type of program, so any results seen cannot be attributed to solely to the program.
• The duration of the intervention may not have been sufficient to see significant changes in the outcome measures.
• The study demonstrated that maintaining involvement and adherence to exercise in this patient population is challenging.
• The findings showed that additional studies of the use of exercise in various patient types should continue because effects and issues seen in this study differ somewhat from those in other patient groups.