Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-31 @ 11:47 PM
Study NCT ID:
NCT05950633
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2023-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Active Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059952', 'term': 'Pelvic Floor Disorders'}], 'ancestors': [{'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Pelvic Floor Distress Inventory-20 (PFDI-20)', 'timeFrame': 'Baseline to 12 weeks post-surgery', 'description': 'The change in the Pelvic Floor Distress Inventory-20 (PFDI-20) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how much symptoms bother them from 0 (not at all) to 4 (quite a bit)'}, {'measure': 'Change in the Short Form Health Survey (SF-36)', 'timeFrame': 'Baseline to 12 weeks', 'description': 'The change in the Short Form Health Survey (SF-36) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their overall health. Scores can range from 0 to 100'}, {'measure': 'Change in the Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline to 12 weeks post-surgery', 'description': 'The change in the Patient Health Questionnaire (PHQ-9) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate how frequently problems have bothered them from 0 (not at all) to 4 (nearly every day)'}, {'measure': 'Change in the Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Baseline to 12 weeks post-surgery', 'description': 'The change in the Patient Global Impressions of Improvement (PGI-I) between arms from baseline to 12 weeks post-surgery. Participants will be asked to rate their symptoms from 1 (very much better) to 7 (very much worse)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Floor Disorders']}, 'descriptionModule': {'briefSummary': 'This is a study evaluating a novel active recovery program in the immediate postoperative period following pelvic reconstructive surgery.', 'detailedDescription': 'This is a randomized controlled trial comparing usual care postoperative restrictions and a novel new active recovery program to look at differences in pelvic floor function, patient quality of life, and mental health in between groups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between the ages of 18 and 89\n2. Undergoing minimally invasive apical prolapse reconstructive procedure at OHSU. This includes laparoscopic and robotic-assisted sacrocolpopexy, laparoscopic and vaginal uterosacral ligament suspension, and vaginal sacrospinous ligament fixation. We will include patients undergoing concomitant procedures such as hysterectomy and incontinence procedures.\n3. Have access to reliable email for communication and questionnaires.\n\nExclusion Criteria:\n\n1. Unable to consent\n2. Unable to read and complete questionnaires in English\n3. Unable to sustain 30 minutes of moderate walking/activity at baseline (self-reported)\n4. Use a mobility assistance device such as a walker/cane at baseline\n5. Balance or stability problems\n6. Patients on chronic opioids'}, 'identificationModule': {'nctId': 'NCT05950633', 'briefTitle': 'Postoperative Active Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Evaluating a Novel Active Recovery Program in the Immediate Postoperative Period Following Pelvic Reconstructive Surgery: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'OHSU IRB 25625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants will receive standard postoperative instructions only', 'interventionNames': ['Other: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Recovery', 'description': 'Participants will receive active recovery instructions with specific walking goals, abdominal strengthening exercises, and pelvic floor exercises', 'interventionNames': ['Other: Active Recovery']}], 'interventions': [{'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Participants will receive standard of care postoperative instructions', 'armGroupLabels': ['Standard of Care']}, {'name': 'Active Recovery', 'type': 'OTHER', 'description': 'Participants will receive instructions to increase their fitness to walking at least 30 minutes a day for 5 days a week following surgery and abdominal and pelvic floor exercises will focus on abdominal wall strengthening and abdominal pressure management, urinary urgency and retention, bowel and constipation management', 'armGroupLabels': ['Active Recovery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Sara Cichowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sara Cichowski', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}