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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
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date December 24, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02620033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
  • Change from baseline level on pro-inflammatory biomarkers [ Time Frame: one year ]
  • Change from baseline level on cellular immune response [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Behavioral: Yoga therapy
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Yoga therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02620033
Other Study ID Numbers  ICMJE HSC2015-406H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP