Hypertension, PulmonaryNCT02647060
The Exercise Capacity and Quality of Life in the Patients With IPAH and Secondary PH
An observational study of Hypertension, Pulmonary, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Pulmonary
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2016to 19 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle
Who may be able to join
- diagnose as pulmonary hypertension
- clinical stable over 3 months
- able to walk and can perform cardiopulmonary exercise testing by bicycle
Who cannot join
- acute right heart failure
- sever arrythmia
- the history of exercise induce syncope
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng Dist, 10055
About this study
Official title: The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension
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.
Read the detailed description
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.
- Conditions
- Hypertension, Pulmonary
- Keywords
- cardiopulmonary exercise testing, right ventricle function, cardio output, pulmonary hypertension, quality of life
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise capacity
cardiopulmonary exercise testing(using ''MetaMax 3B system, CORTEX Biophysik GmbH'' as the measure system, and the data will present as VO2)
Measured: within 1 months after inclusion
quality of life
SF-36
Measured: within 1 months after inclusion
Functional exercise capacity
six minutes walk test
Measured: within 1 months after inclusion
Secondary outcomes (4)
Cardiac function
using non-invasive cardiac output test instrument (Bioelectrical impedance, Physioflow lab1), the data will present as cardiac output(CO)
Measured: within 1 months after inclusion
Volume of regular physical activity
using "Seven day physical activity recall questionnaire"
Measured: within 1 months after inclusion
fatigue severity
using "Fatigue severity scale"
Measured: within 1 months after inclusion
body composition
using bioelectrical impedance (Maltron BioScan BF-920), the data will present as fat percentage
Measured: within 1 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start13 Jan 2016
- Primary completionApr 2016
- Study completion19 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien Meng-Yueh, PhD, Study director, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647060
- Sponsor's protocol ID
- 201511029RINA
- Status last verified
- Jun 2018
- First submitted
- 15 Dec 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exercise Capacity and Quality of Life in the Patients With Idiopathic Pulmonary Arterial Hypertension and Secondary Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02647060
- Acronym / sponsor ID
- 201511029RINA
- Conditions
- Hypertension, Pulmonary
- Keywords
- cardiopulmonary exercise testing, right ventricle function, cardio output, pulmonary hypertension, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 19 Nov 2016 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pulmonary hypertension, clinical stable, able to walk and can perform cardiopulmonary exercise testing by bicycle
Key inclusion criteria (3 listed)
- diagnose as pulmonary hypertension
- clinical stable over 3 months
- able to walk and can perform cardiopulmonary exercise testing by bicycle
Key exclusion criteria (3 listed)
- acute right heart failure
- sever arrythmia
- the history of exercise induce syncope
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
exercise capacity
Time frame: 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)
quality of life
Time frame: within 1 months after inclusion
SF-36
Functional exercise capacity
Time frame: within 1 months after inclusion
six minutes walk test
4 secondary outcomes
Cardiac function
Time frame: within 1 months after inclusion
Volume of regular physical activity
Time frame: within 1 months after inclusion
fatigue severity
Time frame: within 1 months after inclusion
body composition
Time frame: within 1 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chien Meng-Yueh, PhD study director
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise capacity (time frame: within 1 months after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.