- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Zhongzheng Dist
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Taipei, Zhongzheng Dist, Taiwan, 10055
- National Taiwan University Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
idiopathic pulmonary hypertension
|
secondary pulmonary hypertension
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
exercise capacity
Tidsramme: 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
Tidsramme: within 1 months after inclusion
|
SF-36
|
within 1 months after inclusion
|
Functional exercise capacity
Tidsramme: within 1 months after inclusion
|
six minutes walk test
|
within 1 months after inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cardiac function
Tidsramme: 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
Tidsramme: within 1 months after inclusion
|
using "Seven day physical activity recall questionnaire"
|
within 1 months after inclusion
|
fatigue severity
Tidsramme: within 1 months after inclusion
|
using "Fatigue severity scale"
|
within 1 months after inclusion
|
body composition
Tidsramme: within 1 months after inclusion
|
using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
|
within 1 months after inclusion
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Chien Meng-Yueh, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 201511029RINA
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