Impact of Yoga As Complementary Therapy on Quality of Life, Pro-inflammatory, and Cellular Immune Biomarkers in Patients Undergoing Radical Prostatectomy: A Pilot Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Total number of participants recruited to and withdraw from the study
研究概览
简要总结
The researchers hope to learn if yoga complementary therapy would improve health-related quality of life, recovery of urinary continence and erectile function in patients who underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary therapy would improve health- related quality of life (HRQOL), recovery of urinary continence and erectile function.
This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between the age of 30 to 80
- •Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- •Is scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- •Has no other active primary malignancy aside from prostate cancer
- •Currently not practicing yoga as a form of exercise and/or meditation
- •Does not have uncontrolled pain
- •Does not have neurological or musculoskeletal co-morbidity inhibiting exercise
- •Has never been diagnosed by health care professionals to have absolute contraindications to exercise testing
- •Willing to be randomized to either standard care or intervention group
- •Willing to participate in yoga therapy for twelve weeks if randomized to intervention group
- •Willing to undergo phlebotomy
- •Able and willing to provide informed consent
排除标准
- •Men under the age of 30 or over the age of 80
- •Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- •Is NOT scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- •Has other active primary malignancy aside from prostate cancer
- •Currently practicing yoga as a form of exercise and/or meditation
- •Has uncontrolled pain
- •Has neurological or musculoskeletal co-morbidity inhibiting exercise
- •Has been diagnosed with psychotic, addictive, and major cognitive disorders
- •Has been diagnosed by health care professionals to have absolute contraindications to exercise testing Unwilling to be randomized to either standard care or intervention group
- •Unwilling to participate in yoga therapy for twelve weeks if randomized to intervention group
- •Unwilling to undergo phlebotomy
- •Unable and unwilling to provide informed consent
结局指标
主要结局
Total number of participants recruited to and withdraw from the study
时间窗: One year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
时间窗: One year
Total number of participants completed the study
时间窗: One year
Change from baseline in health related quality of life measures
时间窗: One year
health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.
Change from baseline in 6-minute walk test
时间窗: One year
次要结局
- Change from baseline level on pro-inflammatory biomarkers(one year)
- Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)(One year)