- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Zhongzheng Dist
-
Taipei, Zhongzheng Dist, Taiwan, 10055
- National Taiwan University Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
---|
idiopathic pulmonary hypertension
|
secondary pulmonary hypertension
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
exercise capacity
Zeitfenster: 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
Zeitfenster: within 1 months after inclusion
|
SF-36
|
within 1 months after inclusion
|
Functional exercise capacity
Zeitfenster: within 1 months after inclusion
|
six minutes walk test
|
within 1 months after inclusion
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cardiac function
Zeitfenster: 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
Zeitfenster: within 1 months after inclusion
|
using "Seven day physical activity recall questionnaire"
|
within 1 months after inclusion
|
fatigue severity
Zeitfenster: within 1 months after inclusion
|
using "Fatigue severity scale"
|
within 1 months after inclusion
|
body composition
Zeitfenster: within 1 months after inclusion
|
using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
|
within 1 months after inclusion
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Chien Meng-Yueh, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 201511029RINA
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Bluthochdruck, Lungen
-
Nantes University HospitalBeendetZirrhotischer Patient mit Verdacht auf portale Hypertension und im Rahmen eines OV-ScreeningsFrankreich