Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04430751
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Qigong for Mobility and Balance Self-Confidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Community Balance and Mobility Scale', 'timeFrame': 'through study completion, up to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Activities-specific Balance Confidence Scale', 'timeFrame': 'through study completion, up to 16 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Falls, Balance Self-confidence']}, 'referencesModule': {'references': [{'pmid': '32923446', 'type': 'DERIVED', 'citation': 'Stahl JE, Belisle SS, Zhao W. Medical Qigong for Mobility and Balance Self-Confidence in Older Adults. Front Med (Lausanne). 2020 Aug 14;7:422. doi: 10.3389/fmed.2020.00422. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The population is aging and increasingly at risk for falls and fractures with substantial consequences to wellbeing, health and costs. Training interventions such as Tai Chi have been demonstrated to help reduce these risks. Tai chi is a subset of both martial and medical qi gong.\n\nThis is a prospective intervention study with wait time control that will examine the ability of a manualized medical qi gong training protocol improve balance, gait and health self-confidence.\n\nThe intervention is a 12 week manualized medical qi gong training program where students are taught a progressive series of 10 qi gong forms that are designed to build upon each other and restore balance and function. These forms involve both physical movement and visualization.\n\nThe Community Balance and Mobility scale (a performance based measure) and Activities-specified Balance Confidence scale (a survey)will be the prime outcome instruments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 50 years of age or older who presented at the two study locations (Massachusetts, Arizona) were considered eligible for participation\n\nExclusion Criteria:\n\n* Unable to participate in informed consent'}, 'identificationModule': {'nctId': 'NCT04430751', 'briefTitle': 'Medical Qigong for Mobility and Balance Self-Confidence', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Medical Qigong for Mobility and Balance Self-Confidence', 'orgStudyIdInfo': {'id': '250-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Immediate start', 'interventionNames': ['Behavioral: Medical QiGong training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'wait time control', 'interventionNames': ['Behavioral: Medical QiGong training']}], 'interventions': [{'name': 'Medical QiGong training', 'type': 'BEHAVIORAL', 'description': 'The study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong "forms" that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization.', 'armGroupLabels': ['Immediate start', 'wait time control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'blinded de-identified information will be shared at request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'James E. Stahl', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}