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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension, Pulmonary

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Taiwan
  • Zhongzheng Dist
    • Taipei, Zhongzheng Dist, Taiwan, 10055
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
idiopathic pulmonary hypertension; diagnose as idiopathic pulmonary arterial hypertension; clinical stable over 3 months; able to walk and can do bicycle cardiopulmonary exercise testing
secondary pulmonary hypertension; diagnose as pulmonary hypertension; clinical stable over 3 months; able to walk and can do bicycle cardiopulmonary exercise testing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Chien Meng-Yueh, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2016
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): November 19, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; pulmonary hypertension; cardiopulmonary exercise testing; right ventricle function; cardio output
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 201511029RINA