Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-25 @ 7:28 PM
Study NCT ID:
NCT00373932
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-Time Support for Exercise Persistence in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-03', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise behavior', 'timeFrame': '3 & 6 Months'}], 'secondaryOutcomes': [{'measure': 'Self-efficacy for exercise', 'timeFrame': '3 & 6 Months'}, {'measure': 'Perception of support', 'timeFrame': '3 & 6 Months'}, {'measure': 'COPD exacerbation', 'timeFrame': '3 & 6 Months'}, {'measure': 'Exercise Performance', 'timeFrame': '3 & 6 months'}, {'measure': 'Health related quality of life', 'timeFrame': '3 & 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise', 'Physical Activity', 'Adherence'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'COPD', 'Emphysema', 'Chronic Bronchitis']}, 'referencesModule': {'references': [{'pmid': '22772084', 'type': 'DERIVED', 'citation': 'Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.'}, {'pmid': '19750190', 'type': 'DERIVED', 'citation': 'Nguyen HQ, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis. 2009;4:301-13. doi: 10.2147/copd.s6643. Epub 2009 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this exploratory study is to determine the feasibility, acceptability, and efficacy of an exercise persistence intervention for patients with chronic obstructive pulmonary disease (COPD) following pulmonary rehabilitation (PR).', 'detailedDescription': "Exercise, a cornerstone of PR, is effective in improving dyspnea, functioning, and health related quality of life (HRQL) in patients with COPD. However, these improvements gradually dissipate following program completion. There are currently few successful interventions that support patients' persistence with community-based exercise after PR and that have closely monitored the potentially negative impact that COPD exacerbations have on exercise behaviors. Emerging technologies such as wirelessly enabled personal digital assistants (PDA) may provide an innovative means to support exercise persistence through real-time collaborative monitoring of exercise and signs and symptoms of COPD exacerbations and reinforcement to enhance exercise self-efficacy. Patient graduates of two PR programs who have COPD (n=20) will first undergo a 2-week run-in prior to being randomized to either the MOBILE (Mobilizing Support for Long-term Exercise) intervention or attention control for 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe COPD (FEV1/FVC \\<70% and FEV1%\\<80%)\n* Ability to speak, read and write English\n* Age 40 or older\n* Willingness to complete a 6 month program\n\nExclusion Criteria:\n\n* Illnesses such as bronchiectasis, active malignancies or other end stage diseases\n* Plans to continue in a maintenance program after rehabilitation.'}, 'identificationModule': {'nctId': 'NCT00373932', 'briefTitle': 'Real-Time Support for Exercise Persistence in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Real-Time Support for Exercise Persistence in COPD', 'orgStudyIdInfo': {'id': '29494-V2'}, 'secondaryIdInfos': [{'id': 'R03NR009361-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R03NR009361-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOBILE-A', 'description': 'Coached exercise persistence intervention', 'interventionNames': ['Behavioral: Coached exercise persistence intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MOBILE-B', 'description': 'Self-monitored exercise persistence intervention', 'interventionNames': ['Behavioral: Self-Monitored exercise persistence intervention']}], 'interventions': [{'name': 'Coached exercise persistence intervention', 'type': 'BEHAVIORAL', 'description': 'Collaborative symptom and exercise monitoring and weekly reinforcement for exercise persistence from nurse coach via a mobile device and telephone.', 'armGroupLabels': ['MOBILE-A']}, {'name': 'Self-Monitored exercise persistence intervention', 'type': 'BEHAVIORAL', 'description': 'Self-monitoring of symptoms and exercise using a mobile device', 'armGroupLabels': ['MOBILE-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Huong Q. Nguyen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Huong Q. Nguyen, PhD', 'oldOrganization': 'University of Washington'}}}}