Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-08 @ 5:51 PM
Study NCT ID:
NCT02647060
Status:
COMPLETED
Last Update Posted:
2018-07-11
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2016-01-05', 'lastUpdatePostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise capacity', 'timeFrame': 'within 1 months after inclusion', 'description': "cardiopulmonary exercise testing(using ''MetaMax 3B system, CORTEX Biophysik GmbH'' as the measure system, and the data will present as VO2)"}, {'measure': 'quality of life', 'timeFrame': 'within 1 months after inclusion', 'description': 'SF-36'}, {'measure': 'Functional exercise capacity', 'timeFrame': 'within 1 months after inclusion', 'description': 'six minutes walk test'}], 'secondaryOutcomes': [{'measure': 'Cardiac function', 'timeFrame': 'within 1 months after inclusion', 'description': 'using non-invasive cardiac output test instrument (Bioelectrical impedance, Physioflow lab1), the data will present as cardiac output(CO)'}, {'measure': 'Volume of regular physical activity', 'timeFrame': 'within 1 months after inclusion', 'description': 'using "Seven day physical activity recall questionnaire"'}, {'measure': 'fatigue severity', 'timeFrame': 'within 1 months after inclusion', 'description': 'using "Fatigue severity scale"'}, {'measure': 'body composition', 'timeFrame': 'within 1 months after inclusion', 'description': 'using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiopulmonary exercise testing', 'right ventricle function', 'cardio output', 'pulmonary hypertension', 'quality of life'], 'conditions': ['Hypertension, Pulmonary']}, 'descriptionModule': {'briefSummary': 'Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. However patients still have poor exercise capacity and decrease of the quality of life. Past studies have shown that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.', 'detailedDescription': 'Background. Pulmonary hypertension (PH) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. However patients still have poor exercise capacity and decrease of the quality of life. Past studies have shown that idiopathic and secondary PH are different in etiology and prognosis. It is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.\n\nPurpose. The purpose of this study is the comparison of idiopathic and secondary PH in exercise capacity and quality of life, and analyzed the factors affecting.\n\nMethod. The patients recruit from National Taiwan University hospital. Thirty patients who diagnosis with PH and willing to participant our study will recruited. According to the cause of disease patients will divided into two groups, idiopathic group and secondary PH group has fifteen patients. Both of group receive testing, including body composition, exercise capacity (six minutes walk test, cardiopulmonary exercise testing), record their regular physical activity( seven day physical activity recall questionnaire) , fatigue severity(fatigue severity scale), and quality of life (SF-36), monitor cardiac function (non-invasive cardiac output test instrument). Data are analyze using SPSS19.0 version. Data will be presented in mean ± standard deviation and percentage. Using Kolmogorov-Smirmov test to test, whether the data were normal distribution, when P\\> 0.05 is considered as a normal distribution. Mann-Whitney U test or Chi-square test to processing parameters between two groups. Independent sample t test will be used to compare whether there are between-group differences. Pearson correlation coefficient will be used to test correlations between the parameters. The study defines significant level at α = 0.05, two-tailed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria\n\n1. diagnose as pulmonary hypertension\n2. clinical stable over 3 months\n3. able to walk and can perform cardiopulmonary exercise testing by bicycle\n\nexclusion criteria\n\n1. acute right heart failure\n2. sever arrythmia\n3. the history of exercise induce syncope'}, 'identificationModule': {'nctId': 'NCT02647060', 'briefTitle': 'The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '201511029RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'idiopathic pulmonary hypertension', 'description': '1. diagnose as idiopathic pulmonary arterial hypertension\n2. clinical stable over 3 months\n3. able to walk and can do bicycle cardiopulmonary exercise testing'}, {'label': 'secondary pulmonary hypertension', 'description': '1. diagnose as pulmonary hypertension\n2. clinical stable over 3 months\n3. able to walk and can do bicycle cardiopulmonary exercise testing'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10055', 'city': 'Taipei', 'state': 'Zhongzheng Dist', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chien Meng-Yueh, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'School and Graduate Institute of Physical Therapy, National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}