Clinical trial NCT02647060: The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
Official title: The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Keywords: cardiopulmonary exercise testing
right ventricle function
cardio output
pulmonary hypertension
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle

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.

Eligibility criteria: 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

Primary outcomes:
measure: exercise capacity
timeFrame: within 1 months after inclusion
measure: quality of life
timeFrame: within 1 months after inclusion
measure: Functional exercise capacity
timeFrame: within 1 months after inclusion
Secondary outcomes:
measure: Cardiac function
timeFrame: within 1 months after inclusion
measure: Volume of regular physical activity
timeFrame: within 1 months after inclusion
measure: fatigue severity
timeFrame: within 1 months after inclusion
measure: body composition
timeFrame: within 1 months after inclusion
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng Dist
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, National Taiwan University
name: Chien Meng-Yueh, PhD
role: STUDY_DIRECTOR
References: