Skip to main content
OpenTrials
Completed

NCT Number: NCT02647060

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 10055, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. quality of life

    Time frame: within 1 months after inclusion

    SF-36

  3. Functional exercise capacity

    Time frame: within 1 months after inclusion

    six minutes walk test

Secondary outcomes

  1. 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)

  2. Volume of regular physical activity

    Time frame: within 1 months after inclusion

    using "Seven day physical activity recall questionnaire"

  3. fatigue severity

    Time frame: within 1 months after inclusion

    using "Fatigue severity scale"

  4. body composition

    Time frame: within 1 months after inclusion

    using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 6, 2016
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.