The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
1 other identifier
observational
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedStudy Start
First participant enrolled
January 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2016
CompletedJuly 11, 2018
June 1, 2018
3 months
December 15, 2015
July 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
exercise capacity
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
SF-36
within 1 months after inclusion
Functional exercise capacity
six minutes walk test
within 1 months after inclusion
Secondary Outcomes (4)
Cardiac function
within 1 months after inclusion
Volume of regular physical activity
within 1 months after inclusion
fatigue severity
within 1 months after inclusion
body composition
within 1 months after inclusion
Study Arms (2)
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
Eligibility Criteria
pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle
You may qualify if:
- diagnose as pulmonary hypertension
- clinical stable over 3 months
- able to walk and can perform cardiopulmonary exercise testing by bicycle
You may not qualify if:
- acute right heart failure
- sever arrythmia
- the history of exercise induce syncope
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 10055, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chien Meng-Yueh, PhD
School and Graduate Institute of Physical Therapy, National Taiwan University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
January 6, 2016
Study Start
January 13, 2016
Primary Completion
April 1, 2016
Study Completion
November 19, 2016
Last Updated
July 11, 2018
Record last verified: 2018-06