Chronic Obstructive Pulmonary DiseaseNCT03591263
Clinical Outcomes in Patients Referred to Pulmonary Rehabilitation
An observational study of Chronic Obstructive Pulmonary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production, which often misunderstood as aging or catching a cold. These symptoms may be progressive over time. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Pulmonary rehabilitation
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2018to 25 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic respiratory disease: chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis.
Who may be able to join
- age > 20 years old
- patients with chronic respiratory disease diagnosed by physician that referred to pulmonary rehabilitation in National Taiwan University Hospital including, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis
- can cooperate with pulmonary rehabilitation clinic
Who cannot join
- angina, acute myocardial infarction in the previous one month
- pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Physical Therapy Center at National Taiwan University Hospital
Taipei
Li-Ying Wang
About this study
Official title: Longitudinal Study of Clinical Outcomes in Patients Referred to Pulmonary Rehabilitation
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production, which often misunderstood as aging or catching a cold. These symptoms may be progressive over time. To provide better disease management and early detecting, pulmonary rehabilitation is now considered a fundamental component of the integrated disease management of this population. However, few studies have evaluated the beneficial outcomes in patients referred to pulmonary rehabilitation. Therefore, the purpose of this study is to investigate the clinical outcomes in patients referred to pulmonary rehabilitation in National Taiwan University Hospital.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Pulmonary rehabilitation as routine care includes, airway clearance techniques, breathing exercise, and physical training instruction
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | Subjects with the diagnosis of chronic respiratory disease, such as chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis that referred for evaluation as routine care at Physical Therapy Center (National Taiwan University) Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity using the six-minute walk test
The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity.
Measured: The six-minute walk test needs six minute to complete the test
Muscle strength: hand grip
Hand grip strength is performed by using hand dynamometer
Measured: Hand grip of both hands need about three minutes to complete
Lung hygiene
Lung hygiene is evaluated by the frequency of acute exacerbation
Measured: Lung hygiene is evaluated as the frequency of acute exacerbation in the the past one year
Home-based physical activity
All subjects were encouraged to increase their daily physical activity and recorded the amount of physical activity on patient-self-record training log.
Measured: Record the home-based physical activities everyday that the subjects have in the past one week that lasting for one year.
Muscle strength: leg press
Maximum leg press is performed by using seated leg press machine
Measured: Maximum leg press measurement needs about four minutes to complete
Heart rate
Heart rate is measured at rest, during hospital-based physical training.
Measured: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
Blood pressure
systolic and diastolic pressure are measured at rest, during hospital-based physical training.
Measured: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
Perceived dyspnea
Rating of perceived dyspnea is measured by using Borg scale at rest, during hospital-based physical training, and home-based physical activity. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).
Measured: It takes less than one minute to evaluate perceived dyspnea.
Oxygen saturation
Oxygen saturation is continuously monitored by pulse oximetry throughout Hospital-based physical training.
Measured: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start25 Jun 2018
- Primary completion25 Jun 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Ying Wang, Phd, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591263
- Sponsor's protocol ID
- 201805017RINB
- Status last verified
- Apr 2023
- First submitted
- 12 Jun 2018
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Clinical Outcomes in Patients Referred to Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT03591263
- Acronym / sponsor ID
- 201805017RINB
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 19 Jul 2018 (actual)
- 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.
Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production, which often misunderstood as aging or catching a cold. These symptoms may be progressive over time. To provide better disease management and early detecting, pulmonary rehabilitation is now considered a fundamental component of the integrated disease management of this population. However, few studies have evaluated the beneficial outcomes in patients referred to pulmonary rehabilitation. Therefore, the purpose of this study is to investigate the clinical outcomes in patients referred to pulmonary rehabilitation in National Taiwan University Hospital.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | Other: Pulmonary rehabilitationSubjects with the diagnosis of chronic respiratory disease, such as chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis that referred for evaluation as routine care at Physical Therapy Center (National Taiwan University) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic respiratory disease: chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis.
Key inclusion criteria (3 listed)
- age > 20 years old
- patients with chronic respiratory disease diagnosed by physician that referred to pulmonary rehabilitation in National Taiwan University Hospital including, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis
- can cooperate with pulmonary rehabilitation clinic
Key exclusion criteria (2 listed)
- angina, acute myocardial infarction in the previous one month
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationPulmonary rehabilitation as routine care includes, airway clearance techniques, breathing exercise, and physical training instruction | Other | Chronic obstructive pulmonary disease |
Primary outcome
Functional exercise capacity using the six-minute walk test
Time frame: The six-minute walk test needs six minute to complete the test
The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity.
Muscle strength: hand grip
Time frame: Hand grip of both hands need about three minutes to complete
Hand grip strength is performed by using hand dynamometer
Lung hygiene
Time frame: Lung hygiene is evaluated as the frequency of acute exacerbation in the the past one year
Lung hygiene is evaluated by the frequency of acute exacerbation
Home-based physical activity
Time frame: Record the home-based physical activities everyday that the subjects have in the past one week that lasting for one year.
All subjects were encouraged to increase their daily physical activity and recorded the amount of physical activity on patient-self-record training log.
Muscle strength: leg press
Time frame: Maximum leg press measurement needs about four minutes to complete
Maximum leg press is performed by using seated leg press machine
Heart rate
Time frame: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
Heart rate is measured at rest, during hospital-based physical training.
Blood pressure
Time frame: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
systolic and diastolic pressure are measured at rest, during hospital-based physical training.
Perceived dyspnea
Time frame: It takes less than one minute to evaluate perceived dyspnea.
Rating of perceived dyspnea is measured by using Borg scale at rest, during hospital-based physical training, and home-based physical activity. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).
Oxygen saturation
Time frame: Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously
Oxygen saturation is continuously monitored by pulse oximetry throughout Hospital-based physical training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
Li-Ying Wang, Phd study chair
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 Chronic Obstructive Pulmonary Disease, 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 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping-Lun Hsieh (+886-905925933, 107673@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity using the six-minute walk test (time frame: The six-minute walk test needs six minute to complete the test). The study lists 9 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 19 Apr 2023.