- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02647060
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
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Zhongzheng Dist
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Taipei, Zhongzheng Dist, 대만, 10055
- National Taiwan University Hospital
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
idiopathic pulmonary hypertension
|
|
secondary pulmonary hypertension
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
exercise capacity
기간: 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)
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within 1 months after inclusion
|
|
quality of life
기간: within 1 months after inclusion
|
SF-36
|
within 1 months after inclusion
|
|
Functional exercise capacity
기간: within 1 months after inclusion
|
six minutes walk test
|
within 1 months after inclusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiac function
기간: within 1 months after inclusion
|
using non-invasive cardiac output test instrument (Bioelectrical impedance, Physioflow lab1), the data will present as cardiac output(CO)
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within 1 months after inclusion
|
|
Volume of regular physical activity
기간: within 1 months after inclusion
|
using "Seven day physical activity recall questionnaire"
|
within 1 months after inclusion
|
|
fatigue severity
기간: within 1 months after inclusion
|
using "Fatigue severity scale"
|
within 1 months after inclusion
|
|
body composition
기간: within 1 months after inclusion
|
using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
|
within 1 months after inclusion
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Chien Meng-Yueh, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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