Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-28 @ 5:27 PM
Study NCT ID:
NCT05053061
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2021-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telerehabilitation in 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-12', 'studyFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2021-09-21', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-min walk test (6MWT)', 'timeFrame': '8 weeks', 'description': 'exercise capacity'}], 'secondaryOutcomes': [{'measure': 'Short Form-36 (SF-36)', 'timeFrame': '8 weeks', 'description': 'Quality of life'}, {'measure': "St George's Respiratory Questionnaire", 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Pulmonary Rehabilitation', 'Telerehabilitation'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The prevalence of chronic obstructive pulmonary disease (COPD) in Turkey is 10%. Patients with COPD have a decreased physical capacity. Decreased physical activity in COPD patients causes an increase in all-cause mortality. Pulmonary rehabilitation contributes to increasing physical capacity and quality of life in COPD patients. However, a limited number of patients have access to pulmonary rehabilitation. Some of the patients drop out of pulmonary rehabilitation due to reasons such as transport difficulties, low social support, and low professional support. In addition, disruption of daily routine is one of the important reasons for this situation. Telerehabilitation can enable more patients to access pulmonary rehabilitation. Education and exercise programs can be followed with telerehabilitation in patients with COPD. An increase in exercise capacity and a decrease in dyspnea have been achieved with telerehabilitation in COPD patients.\n\nDifferent technologies such as telephone, video conferencing or web sites can be used for telerehabilitation. Also, mobile phone was used to telerehabilitation. To make pulmonary telerehabilitation completely patient-based, we have developed an application suitable for smartphones. The application contains videos which showing how to perform pulmonary rehabilitation exercise videos, and it allows the participants to follow up compliance with pulmonary rehabilitation daily. The application will be downloaded to the smartphones of the participants, and it will be shown how to use the application. Participants will not be shown pulmonary rehabilitation exercises.\n\nThis study aims to evaluate the effectiveness of telerehabilitation with the application program on physical capacity, quality of life, and dyspnea perception in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Being diagnosed with COPD\n* Not have previously participated in pulmonary rehabilitation\n* To able to use smartphone\n\nExclusion Criteria:\n\n* Under age 18\n* Pregnancy\n* Have previously participated in pulmonary rehabilitation\n* Having any malignacy\n* Having any disorder that limit exercise'}, 'identificationModule': {'nctId': 'NCT05053061', 'briefTitle': 'Telerehabilitation in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}, 'officialTitle': 'Does Pulmonary Rehabilitation With Telerehabilitation Increase Physical Capacity in Patients With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'IGHCEAH-ICU6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telerehabilitation Arm', 'interventionNames': ['Behavioral: Application program for pulmonary rehabilitation']}], 'interventions': [{'name': 'Application program for pulmonary rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Exercise videos for pulmonary rehabilitation', 'armGroupLabels': ['Telerehabilitation Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35110', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Cenk Kirakli, M.D.', 'role': 'CONTACT', 'email': 'samicenk.kirakli@sbu.edu.tr', 'phone': '902324333333'}], 'facility': '1University of Health Sciences Turkey, Dr Suat Seren Chest Diseases and Chest Surgery Training and Research Hospital, Intensive Care Unit', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Cenk Kirakli, M.D.', 'investigatorAffiliation': 'Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital'}}}}