Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-31 @ 7:34 PM
Study NCT ID:
NCT05621694
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Oxytocin Response to Meditative Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Meditative movement practice: Tai Chi Easy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The De Jong Gierveld Loneliness Scale', 'timeFrame': 'pre-intervention only', 'description': '6 items each scored either 0 (not at all) 1 (somewhat lonely) or 2 (more lonely), score is computed as a mean across items, range 0-6 with higher scores indicating more loneliness'}, {'measure': 'Flow State Scale', 'timeFrame': 'immediately after the intervention', 'description': 'Used to assess perceptions of the experience of flow while performing the Tai Chi Easy intervention. 36 items, Score range 36-80, high scores indicate greater sense of flow.'}, {'measure': 'Meditative Movement Inventory', 'timeFrame': 'immediately after the intervention', 'description': 'Scales that assess the experience of meditative state and breath focus during intervention, 11 items, score range 11-66 (or reported as a mean of the scores on the scale, then 1-6 range), with higher numbers indicating less breath focus and meditative state.'}], 'primaryOutcomes': [{'measure': 'Change in Blood Pressure', 'timeFrame': 'Change from baseline (pre-intervention) blood pressure to immediately after the 50-minute intervention', 'description': 'Using blood pressure cuff, conducting two consecutive readings of systolic and diastolic'}], 'secondaryOutcomes': [{'measure': 'Change in Profile of Mood States; Short Form', 'timeFrame': 'Change from pre-intervention mood to immediately post-50-minute intervention point', 'description': 'Using only subscales for depression and tension, 14 items with response format 0-4, reporting mean of responses, range 0-4 with higher scores indicating higher levels of depression and tension.'}, {'measure': 'Change in perception of Connection (this is not a published scale, no formal name, created for this study)', 'timeFrame': 'Change from pre-intervention to immediately after the 50-minute intervention', 'description': 'Two items assessing perception of connection with others and connection with self, score range'}, {'measure': 'Change in Salivary Oxytocin', 'timeFrame': 'Change from pre-intervention to immediately after the 50-minute intervention', 'description': 'Saliva collection pre and post-intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '36626941', 'type': 'RESULT', 'citation': 'Larkey LK, James T, Han S, James DL. Pilot study of Qigong/Tai Chi Easy acute effects of meditative movement, breath focus and "flow" on blood pressure, mood and oxytocin in older adults. Complement Ther Med. 2023 Mar;72:102918. doi: 10.1016/j.ctim.2023.102918. Epub 2023 Jan 7.'}]}, 'descriptionModule': {'briefSummary': "This pilot study is designed to test effects of a single session of meditative movement (Tai Chi Easy) on older adults' blood pressure, perceptions of connection, mood, and oxytocin levels.", 'detailedDescription': 'Endogenous oxytocin (the "cuddle hormone") is associated with lowering blood pressure (BP), suggesting that finding ways to increase oxytocin even in the absence of social connection, may be beneficial. Meditative movement emphasizing breath, meditative state and flow-inducing movements holds potential for reducing BP, improving mood and releasing oxytocin. In a single-group pilot study we exposed 21 OAs with mild-moderate hypertension to a 50-minute "Tai Chi Easy (TCE)" (simplified Tai Chi/Qigong) session, collecting BP, saliva samples for oxytocin, and psychosocial measures (connection, mood) pre/post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55-80 --BP above 120/80 -\n\nExclusion Criteria:\n\n* having a neurologic disorder such as Parkinson\'s, seizure disorder, multiple sclerosis, Alzheimer\'s disease\n* answered "yes" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q). The PAR-Q is a seven-question assessment that determines one\'s readiness, safety and ability to engage in physical activity and is safely validated for older adults'}, 'identificationModule': {'nctId': 'NCT05621694', 'briefTitle': 'Exploring Oxytocin Response to Meditative Movement', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Exploring Oxytocin Response to Meditative Movement', 'orgStudyIdInfo': {'id': 'STUDY00006571'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qigong/Tai Chi Intervention', 'description': 'Tai chi and Qigong combined into a simplified, standard practice, "Tai Chi Easy"', 'interventionNames': ['Behavioral: Tai Chi Easy']}], 'interventions': [{'name': 'Tai Chi Easy', 'type': 'BEHAVIORAL', 'otherNames': ['Qigong/Tai Chi; taiji'], 'description': 'A meditative movement practice that includes simple qigong movement/breath practices and single, repeated tai chi movements taught to generate a meditative state and flow', 'armGroupLabels': ['Qigong/Tai Chi Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University Downtown Campus', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85005', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Linda K Larkey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available after study results are published and for 5 years after.', 'ipdSharing': 'YES', 'description': 'Will publish with indication that IPD data that is de-identified is available upon request.', 'accessCriteria': 'Requests from active researchers with current positions in research institutions will be reviewed by PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}