Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-03-09 @ 4:09 AM
Study NCT ID:
NCT01254851
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2010-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Operative Walking Enhancements for Recovery (POWER) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lbrubaker@lumc.edu', 'phone': '708-216-4033', 'title': 'Linda Brubaker', 'organization': 'Loyola University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Difficulty ensuring that encouragement was given, as we did not quantify the frequency of encouragement by the health care team. Loss of data due to loss of pedometers'}}, 'adverseEventsModule': {'timeFrame': 'During Hospitalization.', 'eventGroups': [{'id': 'EG000', 'title': 'Goal-augmented Post-operative Care.', 'description': 'Patients in this group will be given a goal number of steps to take on each post-operative day.', 'otherNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'routine post-operative ambulation', 'otherNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Steps Taken in 24 Hours.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Goal-augmented Post-operative Care.', 'description': 'Patients in this group will be given a goal number of steps to take on each post-operative day.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'routine post-operative ambulation'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2353'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3576'}]}]}], 'analyses': [{'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standardized test statistic (z-score)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.39', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.', 'unitOfMeasure': 'Steps', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is an intention to treat (ITT) analysis comprising all participants who were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Goal-augmented Post-operative Care.', 'description': 'Patients in this group will be given a goal number of steps to take on each post-operative day.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'routine post-operative ambulation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'This randomized controlled trial enrolled patients who were going to undergo gynecologic surgery were enrolled from 1/11-6/11 at Loyola University Medical Center .We approached adult (\\>18 years) English speaking women prior to undergoing major gynecologic surgery who were expected to have at least a 24-hour hospital stay post-operatively.', 'preAssignmentDetails': 'All Enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis had their data lost due to lost pedometer.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Goal-augmented Post-operative Care.', 'description': 'Patients in this group will be given a goal number of steps to take on each post-operative day.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'routine post-operative ambulation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '13.27', 'groupId': 'BG001'}, {'value': '54.98', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2010-12-03', 'resultsFirstSubmitDate': '2012-04-24', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-15', 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Steps Taken in 24 Hours.', 'timeFrame': '1 day', 'description': 'The primary outcome assessed was the number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['discharge criteria, gynecologic surgery, post-op ambulation'], 'conditions': ['External Causes of Morbidity and Mortality']}, 'referencesModule': {'references': [{'pmid': '23635615', 'type': 'DERIVED', 'citation': 'Liebermann M, Awad M, Dejong M, Rivard C, Sinacore J, Brubaker L. Ambulation of hospitalized gynecologic surgical patients: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):533-537. doi: 10.1097/AOG.0b013e318280d50a.'}]}, 'descriptionModule': {'briefSummary': 'This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. goal-augmented post-operative care (they will be given a goal number of steps to take on each post-operative day) following in-patient gynecologic surgery.', 'detailedDescription': "This study is a non-blinded randomized controlled trial. Consenting participants will be randomized to routine post-operative ambulation vs. treadmill-augmented post-operative care (placement of non-motorized treadmill in their room) following in-patient gynecologic surgery.\n\nWe will approach all women undergoing gynecologic procedures that are expected to ambulate within 12 hours of their operation and are anticipated to remain hospitalized at least 18 hours. Following confirmation of eligibility, we will enroll subjects either in the clinic when they are being consented for their gynecologic procedure or upon presentation to the hospital the day of their procedure. Randomization will occur at the completion of the gynecologic procedure when it has been confirmed by the primary surgeon that the patient is able to ambulate independently within 12 hours after completion of the procedure. At that time, participants will be randomized using opaque envelopes prepared by the study statistician in a 1:1 ratio to receive usual post-operative care or treadmill-augmented care.\n\nAll patients will have a pedometer placed on their person in the post-anesthesia recovery unit (PACU) which will be removed the day of their discharge. The primary outcome assessed will be number of steps taken in the 24 hour period prior to discharge as assessed by the electronic pedometer readings.\n\nPedometer will be placed on patients using a lanyard and pedometer clip in the recovery room. No participant will start ambulation without physician's clinical order. When the patient is ready for the first ambulation she will be accompanied by a nurse to sit up in a chair. Once the patient is able to ambulate herself she may ambulate in her room or in the hallway or if randomized to treadmill group she will be able to ambulate on the treadmill. She will be wearing her pedometer at all times until discharge from Loyola."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Independent ambulation pre-operatively\n* Undergoing gynecologic procedure\n* Expected to ambulate within 12 hours of their procedure\n\nExclusion Criteria:\n\n* Children under the age of 18\n* Inability to ambulate independently prior to their surgery\n* Primary surgeon does not want patient to ambulate within 12 hours of procedure\n* English is not the primary language spoken by the patient'}, 'identificationModule': {'nctId': 'NCT01254851', 'acronym': 'POWER', 'briefTitle': 'Post Operative Walking Enhancements for Recovery (POWER) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'Post Operative Walking Enhancements for Recovery (POWER) Trial', 'orgStudyIdInfo': {'id': '203031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'goal-augmented post-operative care.', 'description': 'Patients in this group will be given a goal number of steps to take on each post-operative day.', 'interventionNames': ['Behavioral: goal-augmented post-operative care']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'routine post-operative ambulation'}], 'interventions': [{'name': 'goal-augmented post-operative care', 'type': 'BEHAVIORAL', 'description': 'Patients in the goal-augmented post-operative care group will be given a goal number of steps to take on each post-operative day following in-patient gynecologic surgery.', 'armGroupLabels': ['goal-augmented post-operative care.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '60160', 'city': 'Melrose Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Gottlieb Memorial Hospital', 'geoPoint': {'lat': 41.90059, 'lon': -87.85673}}], 'overallOfficials': [{'name': 'Linda Brubaker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Dean, and Chief Diversity Officer', 'investigatorFullName': 'Linda Brubaker', 'investigatorAffiliation': 'Loyola University'}}}}