Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT02620033
Status:
COMPLETED
Last Update Posted:
2022-01-20
First Post:
2015-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2015-10-15', 'studyFirstSubmitQcDate': '2015-11-29', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in health related quality of life measures', 'timeFrame': 'One year', 'description': 'health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.'}, {'measure': 'Change from baseline in 6-minute walk test', 'timeFrame': 'One year'}, {'measure': 'Total number of participants recruited to and withdraw from the study', 'timeFrame': 'One year'}, {'measure': 'Total number of participants completed the study', 'timeFrame': 'One year'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Change from baseline level on pro-inflammatory biomarkers', 'timeFrame': 'one year'}, {'measure': 'Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostatectomy', 'Yoga therapy', 'Health related quality of life'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34815548', 'type': 'RESULT', 'citation': 'Kaushik D, Shah PK, Mukherjee N, Ji N, Dursun F, Kumar AP, Thompson IM Jr, Mansour AM, Jha R, Yang X, Wang H, Darby N, Ricardo Rivero J, Svatek RS, Liss MA. Effects of yoga in men with prostate cancer on quality of life and immune response: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2022 Sep;25(3):531-538. doi: 10.1038/s41391-021-00470-w. Epub 2021 Nov 23.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men between the age of 30 to 80\n* Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)\n* Is scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)\n* Has no other active primary malignancy aside from prostate cancer\n* Currently not practicing yoga as a form of exercise and/or meditation\n* Does not have uncontrolled pain\n* Does not have neurological or musculoskeletal co-morbidity inhibiting exercise\n* Has never been diagnosed by health care professionals to have absolute contraindications to exercise testing\n* Willing to be randomized to either standard care or intervention group\n* Willing to participate in yoga therapy for twelve weeks if randomized to intervention group\n* Willing to undergo phlebotomy\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Men under the age of 30 or over the age of 80\n* Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)\n* Is NOT scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)\n* Has other active primary malignancy aside from prostate cancer\n* Currently practicing yoga as a form of exercise and/or meditation\n* Has uncontrolled pain\n* Has neurological or musculoskeletal co-morbidity inhibiting exercise\n* Has been diagnosed with psychotic, addictive, and major cognitive disorders\n* 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\n* Unwilling to participate in yoga therapy for twelve weeks if randomized to intervention group\n* Unwilling to undergo phlebotomy\n* Unable and unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02620033', 'briefTitle': 'Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'HSC2015-406H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Yoga therapy group', 'description': "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.", 'interventionNames': ['Behavioral: Yoga therapy']}], 'interventions': [{'name': 'Yoga therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Yoga therapy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78829', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Dharam Kaushik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}