The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension

Conditions
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Hypertension, Pulmonary

Participation Criteria
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Eligibility Criteria
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inclusion criteria diagnose as pulmonary hypertension clinical stable over 3 months able to walk and can perform cardiopulmonary exercise testing by bicycle exclusion criteria acute right heart failure sever arrythmia the history of exercise induce syncope

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| idiopathic pulmonary hypertension<br>diagnose as idiopathic pulmonary arterial hypertension clinical stable over 3 months able to walk and can do bicycle cardiopulmonary exercise testing | |
| secondary pulmonary hypertension<br>diagnose as pulmonary hypertension clinical stable over 3 months able to walk and can do bicycle cardiopulmonary exercise testing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity | cardiopulmonary exercise testing(using ''MetaMax 3B system, CORTEX Biophysik GmbH'' as the measure system, and the data will present as VO2) | within 1 months after inclusion | 
| quality of life | SF-36 | within 1 months after inclusion | 
| Functional exercise capacity | six minutes walk test | within 1 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function | using non-invasive cardiac output test instrument (Bioelectrical impedance, Physioflow lab1), the data will present as cardiac output(CO) | within 1 months after inclusion | 
| Volume of regular physical activity | using Seven day physical activity recall questionnaire | within 1 months after inclusion | 
| fatigue severity | using Fatigue severity scale | within 1 months after inclusion | 
| body composition | using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage | within 1 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiopulmonary exercise testing, right ventricle function, cardio output, pulmonary hypertension, quality of life