Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-01 @ 11:02 PM
Study NCT ID:
NCT01007903
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2009-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind-Body Exercise for COPD: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000088543', 'term': 'Aquatic Therapy'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2009-11-03', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study feasibility'}], 'secondaryOutcomes': [{'measure': 'Quality of life'}, {'measure': 'Exercise capacity'}]}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '20979675', 'type': 'DERIVED', 'citation': 'Yeh GY, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS. Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study. Respir Care. 2010 Nov;55(11):1475-82.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized controlled trial of feasibility and preliminary effects of a 12 week tai chi intervention vs. usual care in patients with chronic obstructive pulmonary disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physician diagnosis of COPD\n* FEV1\\<65% of predicted and FEV1/FVC\\<0.70\n* ≥45 years old\n\nExclusion Criteria:\n\n* COPD exacerbation requiring ER visit or hospitalization within past month\n* planned major pulmonary intervention in coming 3 months\n* severe peripheral vascular disease/claudication or other physical condition precluding walk test\n* inability to perform bicycle ergometry\n* severe cognitive dysfunction (MMSE ≤ 24)\n* inability to speak English\n* current participation in a pulmonary rehabilitation or regular practice of tai chi'}, 'identificationModule': {'nctId': 'NCT01007903', 'briefTitle': 'Mind-Body Exercise for COPD: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Tai Chi Exercise in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2007P000065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care'}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi', 'interventionNames': ['Behavioral: Tai Chi exercise']}], 'interventions': [{'name': 'Tai Chi exercise', 'type': 'BEHAVIORAL', 'description': '12-week tai chi exercise class', 'armGroupLabels': ['Tai Chi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Gloria Yeh, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Medical School (HMS and HSDM)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Gloria Y. Yeh', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}