Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT06847061
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Rehabilitation for Rural Patients With COPD
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study design is control/Wait.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Chronic Respiratory Questionnaire Physical and Emotional (CRQ-SAS) summary scores', 'timeFrame': 'Baseline, 3 months', 'description': "The Chronic Respiratory Disease Questionnaire is a 20 item questionnaire assessing the quality of life for patients with chronic obstructive pulmonary disease (COPD).\n\nThe CRQ covers four domains: dyspnea, fatigue, emotional function, and mastery. Questions are scored on a 7-point Likert scale, with 1 representing 'All of the time' and 7 representing 'None of the time'. Higher scores indicate better outcomes."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the uptake, effectiveness, and patient-caregiver-provider experience of a crucial treatment not provided in rural areas: pulmonary rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 40 years of age or older\n* Physician-diagnosed COPD\n* Living in a rural area defined by Rural-Urban Commuting Area Codes 4-10\n* mMRC score\\>=1\n* English Speaking\n\nExclusion Criteria\n\n* Inability to walk (orthopedic/neurologic/cardiac limitation causing immobility)\n* Cognitive impairment or inability to understand and follow instructions.\n* Patients with no COPD symptom burden, no breathlessness (mMRC score 0), as based on our previous studies they usually perceive no benefit from PR and do not have compliance with PR.\n* Traditional center-based PR was completed within 3 months of initial study recruitment.\n* Transition to hospice or end-of-life care at the time of screening.\n* Acute exacerbation at the time of screening.'}, 'identificationModule': {'nctId': 'NCT06847061', 'briefTitle': 'Pulmonary Rehabilitation for Rural Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Decreasing Disparity in Lung Disease: Pulmonary Rehabilitation for Rural Patients With COPD', 'orgStudyIdInfo': {'id': '24-008332'}, 'secondaryIdInfos': [{'id': '1R01NR021634-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01NR021634-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Subjects randomized to the treatment arm will begin the home-based pulmonary rehabilitation intervention immediately.', 'interventionNames': ['Behavioral: Pulmonary rehabilitation program']}, {'type': 'EXPERIMENTAL', 'label': 'Waitlist Control', 'description': 'Subjects randomized to the waitlist control (usual care) arm will be offered the home-based pulmonary rehabilitation intervention after completing the 12-week control period.', 'interventionNames': ['Behavioral: Pulmonary rehabilitation program']}], 'interventions': [{'name': 'Pulmonary rehabilitation program', 'type': 'BEHAVIORAL', 'description': 'Participants are expected to engage in the home-based pulmonary rehabilitation routine at least 24 minutes a day, five to six days a week for the entire 12-week study period.\n\nThe pulmonary rehabilitation routine begins with slow upper body and timed breathing exercises, followed by two slow balance walks for 6 minutes each. The total exercise time again is 24 minutes, followed by a 4-minute mindful breathing meditation/cool down', 'armGroupLabels': ['Treatment Group', 'Waitlist Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roberto P Benzo, M.D.', 'role': 'CONTACT'}, {'name': 'Roberto P Benzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Teng Moua, M.D.', 'role': 'CONTACT'}, {'name': 'Teng Moua, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Johanna Hoult, M.A.', 'role': 'CONTACT', 'email': 'Hoult.Johanna@mayo.edu', 'phone': '507-293-1989'}], 'overallOfficials': [{'name': 'Roberto Benzo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Teng Moua, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Roberto P. Benzo', 'investigatorAffiliation': 'Mayo Clinic'}}}}