Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-04-01 @ 10:04 AM
Study NCT ID:
NCT00110227
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2005-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tai Chi Mind-Body Therapy for Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2005-05-04', 'studyFirstSubmitQcDate': '2005-05-04', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HF-specific quality of life', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'functional capacity', 'timeFrame': 'baseline and endpoint'}, {'measure': 'Walking Test', 'timeFrame': 'baseline, midpoint, endpoint'}], 'secondaryOutcomes': [{'measure': 'General quality of life', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'mood and emotional status', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'exercise self-efficacy', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'sense of coherence', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'utility assessment', 'timeFrame': 'baseline, midpoint, endpoint, 6mo'}, {'measure': 'beliefs, attitudes, and expectations', 'timeFrame': 'baseline, midpoint, endpoint'}, {'measure': 'physical activity level', 'timeFrame': 'baseline, midpoint, endpoint'}, {'measure': 'perceived social support', 'timeFrame': 'baseline, midpoint, endpoint'}, {'measure': 'neurohormonal status', 'timeFrame': 'baseline, midpoint, endpoint'}, {'measure': 'autonomic tone, heart rate variability', 'timeFrame': 'baseline and endpoint'}, {'measure': 'echocardiography', 'timeFrame': 'baseline and endpoint'}, {'measure': 'costs and use of HF services', 'timeFrame': 'baseline and endpoint'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Complementary Therapies', 'Tai Chi'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '15465501', 'type': 'BACKGROUND', 'citation': 'Yeh GY, Wood MJ, Lorell BH, Stevenson LW, Eisenberg DM, Wayne PM, Goldberger AL, Davis RB, Phillips RS. Effects of tai chi mind-body movement therapy on functional status and exercise capacity in patients with chronic heart failure: a randomized controlled trial. Am J Med. 2004 Oct 15;117(8):541-8. doi: 10.1016/j.amjmed.2004.04.016.'}, {'pmid': '21518942', 'type': 'RESULT', 'citation': 'Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, Davis RB, Phillips RS. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med. 2011 Apr 25;171(8):750-7. doi: 10.1001/archinternmed.2011.150.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of a tai chi exercise program on functional capacity and health-related quality of life in patients with chronic heart failure (HF). This study will also examine the way tai chi influences mental, physical, and social functioning.', 'detailedDescription': 'HF is a major public health problem in the United States, affecting approximately 5 million adults. Despite recent advances in pharmacologic therapy and technologic devices, HF is the most common reason for hospitalization among Medicare patients and is reaching epidemic proportions as the population ages. New and inexpensive interventions that can improve functional capacity and quality of life and can delay disease progression are needed. Tai chi is a popular mind-body exercise that is a potential treatment for heart disease. This exercise incorporates both gentle physical activity and meditation, and it may be particularly suited to frail patients with HF. This study will examine the effects of a tailored tai chi program on functional capacity and quality of life in patients with HF.\n\nParticipants will be randomly assigned to either a tai chi program or heart health education for 12 weeks. Participants in both groups will undergo a bicycle stress test at study entry and will receive weekly training sessions of their assigned intervention. Self-report scales and questionnaires will be used to assess participants at study start and at the end of 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic HF\n* Percentage of blood pumped from the left ventricle (ventricular ejection fraction) less than 40% for at least 1 year prior to study entry\n* Stable medical regimen, defined as no major changes in medication, in the 3 months prior to study entry\n* New York Heart Association Classification of Class I (no activity limitations), Class II (slight activity limitations), or Class III (marked activity limitations)\n* English-speaking\n\nExclusion Criteria:\n\n* Unstable angina, myocardial infarction, cardiac resynchronization, or major cardiac surgery within 3 months prior to study entry\n* History of cardiac arrest or diagnosis of peripartum cardiomyopathy within 6 months prior to study entry\n* Unstable ventricular arrhythmias or structural valvular disease\n* Current participation in a conventional cardiac rehabilitation program\n* Inability to perform a bicycle stress test at study entry\n* Lower extremity amputation or other inability to walk due to conditions other than HF\n* Severe cognitive dysfunction preventing informed consent and understanding of tai chi concept\n* Current regular practice of tai chi\n* Current participation in a tai chi pilot study or other studies'}, 'identificationModule': {'nctId': 'NCT00110227', 'acronym': 'NEXT-Heart', 'briefTitle': 'Tai Chi Mind-Body Therapy for Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Tai Chi Mind-Body Therapy for Chronic Heart Failure', 'orgStudyIdInfo': {'id': '2004P000390'}, 'secondaryIdInfos': [{'id': 'R01AT002454', 'link': 'https://reporter.nih.gov/quickSearch/R01AT002454', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi', 'description': '12-week tai chi program', 'interventionNames': ['Behavioral: 12-week Tai Chi Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heart Health Education', 'description': '12-week attention control', 'interventionNames': ['Behavioral: 12-week Education Program']}], 'interventions': [{'name': '12-week Tai Chi Program', 'type': 'BEHAVIORAL', 'description': '24 tai chi sessions. 2 sessions/week for 12 weeks.', 'armGroupLabels': ['Tai Chi']}, {'name': '12-week Education Program', 'type': 'BEHAVIORAL', 'description': '24 Educational sessions. 2 sessions/week for 12 weeks.', 'armGroupLabels': ['Heart Health Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center, Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02446', 'city': 'Brookline', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lown Cardiovascular Center', 'geoPoint': {'lat': 42.33176, 'lon': -71.12116}}], 'overallOfficials': [{'name': 'Russell S. Phillips, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School'}, {'name': 'Ellen P. McCarthy, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Gloria Y. Yeh', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}