Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT03162133
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2017-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2017-05-12', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Quality of Life (QoL) at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 version 3 (EORTC QLQ-C30)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline IL-6 at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'proinflammatory cytokines interleukin-6'}, {'measure': 'Change from Baseline Fatigue at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Piper fatigue questionnaire'}, {'measure': 'Change from Baseline sleep quality at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Pittsburgh sleep quality index, PSQI'}, {'measure': 'Change from Baseline Aromatase Inhibitor-Induced Arthralgia at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Brief Pain Inventory-Short Form'}, {'measure': 'Change from Baseline Symptoms of climacteric syndrome at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Kupperman Index'}, {'measure': 'Change from Baseline BMD at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Bone mineral density'}, {'measure': 'Change from Baseline BMI at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Body Mass Index'}, {'measure': 'Change from Baseline Aerobic Fitness Assessment at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Six-min walk test (6MWT)'}, {'measure': 'Change from Baseline Muscle strength test at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Upper strength: hand grip (measured by a dynamometer; the average of 3 readings) lower limb strength：sit-to-stand (measured as number of reps in a 30-s period)'}, {'measure': 'Change from Baseline Flexibility test at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'Test of scratching his back and Sit in the chair and reach'}, {'measure': 'Change from Baseline Balance test at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'stand on one foot'}, {'measure': 'Change from Baseline TNF-α at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'tumor necrosis factor alpha'}, {'measure': 'Change from Baseline IL-1β at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'interleukin-1β'}, {'measure': 'Change from Baseline CRP at 3 months', 'timeFrame': 'at baseline and 3 months', 'description': 'C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Aromatase Inhibitor Therapy', 'Baduanjin Exercise'], 'conditions': ['Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy']}, 'descriptionModule': {'briefSummary': 'A 12-week randomized controlled trail was conducted in 72 Chinese breast cancer survivors who had received aromatase inhibitors treatment for more than 6 months. All participants were assigned to either 12 weeks of Baduanjin classes which involved to two 90-minute sessions per week or a wait-list control. Participants completed fitness assessments, measurements of lipopolysaccharide-stimulated production of proinflammatory cytokines interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), interleukin-1β(IL-1β) ,C-reactive protein (CRP) ，BMI，BMD and questionnaires to measure QoL, fatigue, sleep quality, Aromatase Inhibitor-Induced Arthralgia, symptoms of climacteric syndrome were completed at baseline and 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed as stage I to III breast cancer 0.5 to 4.0 years before enrollment\n* Taking an AI (aromatase inhibitors )，and had been receiving an AI for at least 6 months\n\nExclusion Criteria:\n\n* A prior history of breast or any other cancer except basal or squamous cell skin cancer Inflammatory breast cancer\n* With exercise contraindications：chronic obstructive pulmonary disease, uncontrolled hypertension, evidence of liver or kidney failure, symptomatic ischemic heart disease ,conditions involving the immune system such as autoimmune and/or inflammatory diseases, cognitive impairment, alcohol/drug abuse\n* Current Baduanjin practice (within the last 6 months), and/or previous Baduanjin practice for more than 3 months\n* Women reporting 5 hours or more of vigorous physical activity per week'}, 'identificationModule': {'nctId': 'NCT03162133', 'briefTitle': 'Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Evaluating the Impact of Baduanjin Exercise Intervention on Quality of Life in Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy：: A Pilot Study', 'orgStudyIdInfo': {'id': '20170217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise group', 'description': 'After completing the baseline tests, participants in exercise group were instructed to attend 90-minute, supervised Baduanjin exercise 2 times per week. The Baduanjin intervention used the standardized Baduanjin training program, designed by the General Administration of Sports of China. Two senior Baduanjin teachers from Guangzhou Sports University conducted the training.', 'interventionNames': ['Other: Baduanjin exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Waiting list Control group', 'description': 'Participants assigned to the wait-list control were told to continue performing their usual care and daily activities, and to refrain from doing any Baduanjin exercise.\n\nAfter their post-assessment they were able to attend the Baduanjin classes.', 'interventionNames': ['Other: Baduanjin exercise']}], 'interventions': [{'name': 'Baduanjin exercise', 'type': 'OTHER', 'armGroupLabels': ['Exercise group', 'Waiting list Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Kun Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangzhou Sport University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'KunWang', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}