A Pilot Study of Physical Activity for Improving Quality of Life in Prostate Cancer Patients on Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility of recruiting 60 men with prostate CA on ADT to an ex intervention study w/ three arms. To determine if an ex prgm provides symptom mgt as compared to usual care,if resistance training provides symptom mgt not obtained from aerobic ex alone.
研究概览
简要总结
60 eligible subjects will be randomized into one of three study arms 1) aerobic exercise, 2) resistance exercise, or 3) usual care. Baseline measurements will be done on all study subjects, these measurements include: height, weight, dual energy x-ray absorptiometry (DXA) for bone mineral density and lean body mass measurements, blood will be taken to measure serum free testosterone, prostate-specific antigen (PSA), glucose, and insulin levels. Fitness will also be evaluated using a graded exercise test. Questionnaires on health and personal history will also be completed. Men randomized to the aerobic exercise treatment arm will participate in a walking program three times a week for eight weeks. The participants will start at 15 minutes per session and increase to a goal of 60 minutes per session. Men randomized to the resistance training treatment arm will participate in an eight-week program of eight strength training exercises three times per week. Men in the usual care arm will receive written materials from the American Cancer Society about coping with cancer, which includes information about participation in physical activity. At the end of the eight week intervention participants in all three study arms will complete the same questionnaires and measurements they completed at baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with metastatic prostate cancer receiving ADT and men who have failed primary therapy and are receiving ADT.
- •Men from the radiology practice who are receiving ADT as neoadjuvant therapy to primary radiotherapy (enrolled only following completion of primary radiotherapy).
排除标准
- •Men with the following counter-indications to exercise:
- •Lower limb, bone, muscle, or joint pathology of a severity which limits their ability to be physically active.
- •A history of significant cardiac disease using criteria established by the American College of Sports Medicine ( Criteria: pain, discomfort in the chest, neck, jaw, arms, or other areas that may be due to ischemia; shortness of breath at rest or with mild exertion; ankle edema; palpitations or tachycardia; known heart murmur; unusual fatigue or shortness of breath with usual activities' syncope)
- •Other medical contraindications which would compromise participation in a lifestyle physical activity program.
- •Those who are currently physically active
研究组 & 干预措施
aerobic exercise
Subjects who are randomly assigned to this arm will be assigned a walking program to participate in 3 times a week for eight weeks
干预措施: walking exercise (Behavioral)
resistence training
Subjects who are randomly assigned to this arm will be assigned a weight training program to participate in 3 times a week for eight weeks
干预措施: weight training (Behavioral)
Usual Care
Subjects who are randomly assigned to this arm will not participate in any exercise program and will continue with usual care treatment
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Feasibility of recruiting 60 men with prostate CA on ADT to an ex intervention study w/ three arms. To determine if an ex prgm provides symptom mgt as compared to usual care,if resistance training provides symptom mgt not obtained from aerobic ex alone.
时间窗: 8 weeks
次要结局
未报告次要终点