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Clinical Trials/NCT02647060
NCT02647060
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country26 target enrollmentJanuary 13, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension, Pulmonary
Sponsor
National Taiwan University Hospital
Enrollment
26
Locations
1
Primary Endpoint
exercise capacity
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2016
End Date
November 19, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Cardiac function(within 1 months after inclusion)
  • Volume of regular physical activity(within 1 months after inclusion)
  • fatigue severity(within 1 months after inclusion)
  • body composition(within 1 months after inclusion)

Study Sites (1)

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