The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
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|ClinicalTrials.gov Identifier: NCT02647060|
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : July 11, 2018
|Condition or disease|
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.
Purpose. 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.
Method. 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.
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension|
|Actual Study Start Date :||January 13, 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||November 19, 2016|
idiopathic pulmonary hypertension
secondary pulmonary hypertension
- exercise capacity [ Time Frame: within 1 months after inclusion ]cardiopulmonary exercise testing(using ''MetaMax 3B system, CORTEX Biophysik GmbH'' as the measure system, and the data will present as VO2)
- quality of life [ Time Frame: within 1 months after inclusion ]SF-36
- Functional exercise capacity [ Time Frame: within 1 months after inclusion ]six minutes walk test
- Cardiac function [ Time Frame: within 1 months after inclusion ]using non-invasive cardiac output test instrument (Bioelectrical impedance, Physioflow lab1), the data will present as cardiac output(CO)
- Volume of regular physical activity [ Time Frame: within 1 months after inclusion ]using "Seven day physical activity recall questionnaire"
- fatigue severity [ Time Frame: within 1 months after inclusion ]using "Fatigue severity scale"
- body composition [ Time Frame: within 1 months after inclusion ]using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647060
|National Taiwan University Hospital|
|Taipei, Zhongzheng Dist, Taiwan, 10055|
|Study Director:||Chien Meng-Yueh, PhD||School and Graduate Institute of Physical Therapy, National Taiwan University|