Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT02620033|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : December 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Yoga therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
No Intervention: Standard Care
Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.
Active Comparator: Yoga therapy group
Those assigned to the yoga therapy group will be asked to participate in yoga session three times in a week for 6 weeks prior to the scheduled surgery and then re-initiated 3 weeks after the surgery for another 6 weeks. Each session will be approximately 60 - 75 minutes. These yoga session will be held at Nydia's Yoga Therapy Studio, located in San Antonio, TX, under the guidance of certified yoga instructor, Dr. Nydia Tijerina Darby, PT, DPT, MS, who's the owner of the studio and co-investigator of this study. The yoga exercise will be tailored to patient's comfort level.
Behavioral: Yoga therapy
- Change from baseline in health related quality of life measures [ Time Frame: 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 [ Time Frame: One year ]
- Total number of participants recruited to and withdraw from the study [ Time Frame: One year ]
- Total number of participants completed the study [ Time Frame: One year ]
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: One year ]
- Change from baseline level on pro-inflammatory biomarkers [ Time Frame: one year ]
- Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells) [ Time Frame: One year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620033
|United States, Texas|
|University of Texas Health Science Center at San Antonio||Recruiting|
|San Antonio, Texas, United States, 78829|
|Contact: Grace Ihsiu Todd, MSN, ANP-BC 210-550-0715 firstname.lastname@example.org|
|Contact: Dharam Kaushik, MD 210-567-5676 email@example.com|
|Principal Investigator: Dharam Kaushik, MD|
|Sub-Investigator: Nydia Tijerina Darby, PT, DPT, MS|
|Sub-Investigator: Stacey Young-McCaughan, RN, PhD|