Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-29 @ 1:42 AM
Study NCT ID:
NCT04722393
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2021-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Resection and Pulmonary Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pulmonary Rehabilitation Group and Control Group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Capacity', 'timeFrame': 'up to 8 weeks', 'description': 'Six minutes walk test'}], 'secondaryOutcomes': [{'measure': 'Respiratory Functions', 'timeFrame': 'up to 8 weeks', 'description': "Pulmonary Function Test Pulmonary function test (PFT) which is noninvasive tests that show how well the lungs are working. The tests will measure FEV1; It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration.\n\nFVC: It s the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible, as measured by spirometry FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC)."}, {'measure': 'Dyspnea Sensation', 'timeFrame': 'up to 8 weeks', 'description': 'Modified Medical Research Council (MMRC)" dyspnea scale, which consists of 5 items ranging between 1 and 5, to determine the severity of patients\' shortness of breath. Higher scores mean a worse outcome.'}, {'measure': 'Disease Specific Quality of Life', 'timeFrame': 'up to 8 weeks', 'description': "St. George's Respiratory Questionnaire (SGRQ) to determine disease-specific quality of life. At this scale, high scores define worsened disease and increased symptoms. Higher scores mean a worse outcome."}, {'measure': 'Anxiety', 'timeFrame': 'up to 8 weeks', 'description': 'Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.'}, {'measure': 'Depression', 'timeFrame': 'up to 8 weeks', 'description': 'Hospital Anxiety and Depression (HAD) Inventory for assessment of anxiety and depression. In this scale; scores of anxiety and depression are calculated separately. The maximum score for both is 21 and high scores correspond to high degree anxiety and depression. Cut-off scores for anxiety and depression were determined as 10/11 and 7/8 respectively.'}, {'measure': 'Body Mass Index', 'timeFrame': 'up to 8 weeks', 'description': 'Body mass index is calculated by dividing body mass by the square of length in meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary rehabilitation', 'lung surgery', 'lung cancer'], 'conditions': ['Pulmonary Rehabilitation', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': "Lung cancer is the most common cancer in the world and surgical resection remains the gold standard curative treatment in early stage non-small cell lung cancer. However, surgery itself is the direct cause of pulmonary function impairment, which dramatically reduces patients tolerance to exercise and their quality of life. Pulmonary rehabilitation (PR) complements surgical treatment and improves patients' exercise and functional capacity, decreases dyspnea, improves health status.\n\nOur aim is to examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.", 'detailedDescription': 'Pulmonary rehabilitation (PR) is an evidence-based, interdisciplinary, comprehensive exercise program that targets patients with symptomatic chronic respiratory disease. PR integrates exercise and training interventions into a personalized treatment program. PR has become an important component of the general treatment strategy in patients with high-risk surgical diseases such as lung resection. It helps patients return to normal not only physically, but also emotionally and mentally. In patients with lung cancer, preoperative PR increases exercise capacity, decreases post-operative morbidity and mortality. Although it is reported that the PR program applied in the post-operative period increases physical performance and improves the quality of life, referral of patients in need of the PR unit is less than 25%. There is a need to increase the awareness of both pulmonologists and thoracic surgeons about the benefits of the PR program, which is a non-pharmacological and effective intervention.\n\nThe investigators have had two objectives in this study. 1- To examine the effectiveness of PR applied after lung resection in patients with lung cancer, 2- To determine whether the respiratory exercise training given to patients who could not participate in the PR program is effective.\n\nAn 8-week comprehensive outpatient PR program will applied to half of 66 patients with non-small cell lung cancer who underwent lung resection, and the other half received respiratory exercise training. After the intervention, the results of both groups will compare.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had undergone surgery for non-small cell lung cancer in the last two years\n* Patients who had no chemotherapy or radiotherapy\n\nExclusion Criteria:\n\n* Patients who were found unsuitable with the cardiology consultation\n* Patients with psychiatric problems\n* Patients with severe joint diseases\n* Reluctant patients'}, 'identificationModule': {'nctId': 'NCT04722393', 'briefTitle': 'Lung Resection and Pulmonary Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Outcomes of Pulmonary Rehabilitation After Lung Resection in Patients With Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'IKC123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary Rehabilitation Group', 'description': 'An 8-week comprehensive outpatient PR program including respiratory exercises, aerobic and strengthening training', 'interventionNames': ['Other: Exercise']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Respiratory exercises', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Exercise training', 'armGroupLabels': ['Control Group', 'Pulmonary Rehabilitation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35620', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'İlknur Naz Gürşan', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof', 'investigatorFullName': 'Ilknur Naz', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}