Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-30 @ 2:36 PM
Study NCT ID:
NCT04481295
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2020-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-25', 'studyFirstSubmitDate': '2020-07-19', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the six-minutes walking distance prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}], 'secondaryOutcomes': [{'measure': 'Change in the six-minutes walking test (lowest SpO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the constant-load exercise test (duration time etc.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the incremental-exercise test (Maximum load value etc.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the body composition measured by InBody (muscle mass et.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the arterial blood gas (PaO2 value etc.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the inflammation marker (CRP etc.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the nutritional status (body mass index(kg/m2) et.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the sympathetic activity (Plasma catecholamine et.) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}, {'measure': 'Change in the dyspnea (Modified Borg scale) prior to and following 4 weeks of pulmonary rehabilitation', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFNC', '6MWD'], 'conditions': ['High-flow Nasal Cannula', 'Exercise Capacity', 'Chronic Respiratory Failure', 'Optimal SpO2 Value']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.', 'detailedDescription': 'In patients with chronic respiratory failure, pulmonary rehabilitation is recognized as an evidence-based treatment in improving exercise capacity, muscle strength, dyspnea, and quality of life. However, optimal SpO2 value during pulmonary rehabilitation in patients with chronic respiratory failure receiving long-term oxygen therapy is unclear.\n\nThe present study is randomized to compare the effect of exercise capacity between high SpO2 (Minimum SpO2 94-96%) value during pulmonary rehabilitation and low SpO2 (Minimum SpO2 84-86%) value during pulmonary rehabilitation for the patients with chronic respiratory failure receiving long-term oxygen therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months.\n\nExclusion Criteria:\n\n* Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure.\n* Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month.\n* Subjects with changes in LTOT prescription flow within the last month\n* Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.'}, 'identificationModule': {'nctId': 'NCT04481295', 'briefTitle': 'Study on Optimal Oxygen Concentration During Pulmonary Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'National Hospital Organization Minami Kyoto Hospital'}, 'officialTitle': 'Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula', 'orgStudyIdInfo': {'id': '2019-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High SpO2 group', 'description': 'In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 94-96%, and a flow of 10 L/min).', 'interventionNames': ['Other: High-flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low SpO2 group', 'description': 'In this group, patients have undergone 4 weeks of pulmonary rehabilitation under the HFNC (FIO2 value that the minimum SpO2 value during pulmonary rehabilitation is 84-86%, and a flow of 10 L/min).', 'interventionNames': ['Other: Low SpO2']}], 'interventions': [{'name': 'High-flow nasal cannula', 'type': 'OTHER', 'description': 'The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.', 'armGroupLabels': ['High SpO2 group']}, {'name': 'Low SpO2', 'type': 'OTHER', 'description': 'Low SpO2', 'armGroupLabels': ['Low SpO2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610-0113', 'city': 'Jōyō', 'state': 'Kyoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yuichi Chihara, MD., PhD.', 'role': 'CONTACT', 'email': 'yc.r03107@gmail.com', 'phone': '81-774-52-0065'}], 'facility': 'National Hospital Organization Minami Kyoto Hospital', 'geoPoint': {'lat': 34.84396, 'lon': 135.80561}}], 'centralContacts': [{'name': 'Yuichi Chihara', 'role': 'CONTACT', 'email': 'yc.r03107@gmail.com', 'phone': '81-774-52-0065'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Hospital Organization Minami Kyoto Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}