Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Completed

CT.gov ID

NCT02620033

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Behavioral: Yoga therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

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

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Jun 29, 2020

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change from baseline in health related quality of life measures [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 [One year]
Total number of participants recruited to and withdraw from the study [One year]
Total number of participants completed the study [One year]
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [One year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78829

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator: Dharam Kaushik, MD, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT02620033

Other Study ID Numbers:

HSC2015-406H

First Posted:

Dec 2, 2015

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Keywords provided by The University of Texas Health Science Center at San Antonio

Prostatectomy

Yoga therapy

Health related quality of life

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jan 20, 2022