Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00034112
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026301', 'term': 'Manipulation, Osteopathic'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2002-03'}, 'lastUpdateSubmitDate': '2006-08-17', 'studyFirstSubmitDate': '2002-04-22', 'studyFirstSubmitQcDate': '2002-04-22', 'lastUpdatePostDateStruct': {'date': '2006-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-04-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['chronic obstructive pulmonary disease', 'combination therapy,', 'emphysema', 'exercise', 'human therapy evaluation', 'rehabilitation', 'respiratory disease /disorder therapy', 'respiratory function', 'biomechanics', 'body movement', 'diaphragm', 'dyspnea', 'muscle tension', 'musculoskeletal system', 'outcomes research', 'quality of life', 'somatic reflex'], 'conditions': ['Emphysema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.', 'detailedDescription': 'OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.\n\nParticipants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False}, 'identificationModule': {'nctId': 'NCT00034112', 'briefTitle': 'Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'R21AT000207-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT000207-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'osteopathic manipulative treatment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63501', 'city': 'Kirksville', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kirksville College of Osteopathic Medicine', 'geoPoint': {'lat': 40.19475, 'lon': -92.58325}}], 'overallOfficials': [{'name': 'Donald R. Noll', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirksville College of Osteopathic Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}