- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Zhongzheng Dist
-
Taipei, Zhongzheng Dist, Taiwan, 10055
- National Taiwan University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
idiopathic pulmonary hypertension
|
secondary pulmonary hypertension
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
exercise capacity
Tidsram: 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)
|
within 1 months after inclusion
|
quality of life
Tidsram: within 1 months after inclusion
|
SF-36
|
within 1 months after inclusion
|
Functional exercise capacity
Tidsram: within 1 months after inclusion
|
six minutes walk test
|
within 1 months after inclusion
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Cardiac function
Tidsram: within 1 months after inclusion
|
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
Tidsram: within 1 months after inclusion
|
using "Seven day physical activity recall questionnaire"
|
within 1 months after inclusion
|
fatigue severity
Tidsram: within 1 months after inclusion
|
using "Fatigue severity scale"
|
within 1 months after inclusion
|
body composition
Tidsram: within 1 months after inclusion
|
using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
|
within 1 months after inclusion
|
Samarbetspartners och utredare
Utredare
- Studierektor: Chien Meng-Yueh, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 201511029RINA
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