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

NCT ID: NCT02647060

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-13
• Study Completion Date: 2016-11-19

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.

Conditions

Hypertension, Pulmonary

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

idiopathic pulmonary hypertension

1. diagnose as idiopathic pulmonary arterial hypertension

2. clinical stable over 3 months

3. able to walk and can do bicycle cardiopulmonary exercise testing

No interventions assigned to this group

secondary pulmonary hypertension

1. diagnose as pulmonary hypertension

2. clinical stable over 3 months

3. able to walk and can do bicycle cardiopulmonary exercise testing

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chien Meng-Yueh, PhD

Role: STUDY_DIRECTOR

School and Graduate Institute of Physical Therapy, National Taiwan University

Locations

National Taiwan University Hospital

Taipei, Zhongzheng Dist, Taiwan

Countries

Taiwan

Other Identifiers

201511029RINA

Identifier Type: -

Identifier Source: org_study_id