An interventional study of Yoga therapy in Prostate Cancer, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to male participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 443 studies on the registry; 88 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
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Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.
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
health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.
Time frame: One year
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
Ran from Sep 2015 to primary completion in Jun 2020, 57 months.
Of 1,018 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 87. This study's 57 months is above that.
Counting every sponsor, half of 1,063 studies reached it within 45 months; a quarter within 22 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio →