The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
- Conditions
- Hypertension, Pulmonary
- Registration Number
- NCT02647060
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method exercise capacity 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 within 1 months after inclusion SF-36
Functional exercise capacity within 1 months after inclusion six minutes walk test
- Secondary Outcome Measures
Name Time Method Cardiac function 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 within 1 months after inclusion using "Seven day physical activity recall questionnaire"
fatigue severity within 1 months after inclusion using "Fatigue severity scale"
body composition within 1 months after inclusion using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Zhongzheng Dist, Taiwan