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

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ClinicalTrials.gov Identifier: NCT02647060
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease
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
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : November 19, 2016


Group/Cohort
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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647060


Locations
Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng Dist, Taiwan, 10055
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Chien Meng-Yueh, PhD School and Graduate Institute of Physical Therapy, National Taiwan University

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02647060     History of Changes
Other Study ID Numbers: 201511029RINA
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018

Keywords provided by National Taiwan University Hospital:
cardiopulmonary exercise testing
right ventricle function
cardio output
pulmonary hypertension
quality of life

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases