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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02647060

Enrollment

Registered

2016-01-06

Start date

2016-01-13

Completion date

2016-11-19

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pulmonary

Keywords

cardiopulmonary exercise testing, right ventricle function, cardio output, pulmonary hypertension, quality of life

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. diagnose as pulmonary hypertension 2. clinical stable over 3 months 3. able to walk and can perform cardiopulmonary exercise testing by bicycle

Exclusion criteria

1. acute right heart failure 2. sever arrythmia 3. the history of exercise induce syncope

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
body composition	within 1 months after inclusion	using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
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

Countries

Taiwan

Outcome results