COPD Received PRNCT05240989
Correlation Between Pulmonary Rehabilitation and TFC
An observational study of COPD Received PR, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
To study the effects of lung rehabilitation on the heart's hemodynamic performance of patients with chronic bidirectional lung disease when performing routine and regular PR, and found that the effects of lung rehabilitation on the heart mechanism and patients long-term quality of life research. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Received PR
- What is being tested?
- pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2021to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of Affiliated University Hospital
Who may be able to join
- treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic
- signing of the subject's consent
Who cannot join
- gas-cut patients
- patients who cannot perform conventional lung rehabilitation
- patients who use respirators at home
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, M.Sc, +886952909103, ck_qq@hotmail.con
Ke-Yun Chao, M.Sc
About this study
Official title: Correlation Between Pulmonary Rehabilitation and Thoracic Fluid Capacity: One-year Follow-up of Observation Research
To study the effects of lung rehabilitation on the heart's hemodynamic performance of patients with chronic bidirectional lung disease when performing routine and regular PR, and found that the effects of lung rehabilitation on the heart mechanism and patients long-term quality of life research.
Read the detailed description
This study will be conducted in the Pulmonary Rehabilitation Treatment Room on the 6th floor of the Affiliated University Hospital. The acceptance conditions are: (1) treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic, and (2) signing of the subject's consent; exclusion conditions: (1) tracheostomized patients, (2) patients who cannot perform conventional lung rehabilitation, (3) patients who use respirators at home.
The study is a prospective observational study. It is expected to include a total of 25 subjects. The study will be implemented for one year from the date of IRB adoption. Before performing PR treatment, performed the 6th and 12th Every month, routine lung function, six-minute walking tests, and non-invasive cardiac output measurements are performed. The main results are: cardiac hemodynamic parameters.
- Conditions
- COPD Received PR
- Being tested
- pulmonary rehabilitation
- Keywords
- pulmonary rehabilitation, negative pressure ventilation, electrical cardiometry, chronic obstructive pulmonary disease
- 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 rehabilitationProcedure or surgery
one-year regular lung rehabilitation treatment and control the intensive monitoring of hemodynamic parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac hemodynamic parameters
heart rate (HR)
Measured: one year
cardiac hemodynamic parameters
blood pressure (BP)
Measured: one year
cardiac hemodynamic parameters
stroke volume (SV)
Measured: one year
cardiac hemodynamic parameters
cardiac output (CO)
Measured: one year
cardiac hemodynamic parameters
total peripheral resistance (TPR)
Measured: one year
Secondary outcomes (3)
mMRC (Modified Medical Research Council) Dyspnea Scale Dyspnea Scale
assessing the severity of breathlessness in patients with COPD
Measured: one year
Chronic Respiratory Disease Questionnaire
The Chronic Respiratory Disease Questionnaire (CRQ) is the most commonly used disease specific measurement tool to assess health related quality of life (HRQL) in patients with chronic respiratory disease. It examines four aspects of patients' lives: dyspnoea, fatigue, emotional function, and mastery (the feeling of control over the disease and its effects).
Measured: one year
COPD Assessment Test
measure the impact of COPD on a person's life, and how this changes over time. Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dysnea, chest tighteness) on health status. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start22 Oct 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD Received PRStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Yun, Chao, Fu Jen Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240989
- Sponsor's protocol ID
- PL-202008027-M
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farias CC, Resqueti V, Dias FA, Borghi-Silva A, Arena R, Fregonezi GA. Costs and benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease: a randomized controlled trial. Braz J Phys Ther. 2014 Mar-Apr;18(2):165-73. doi: 10.1590/s1413-35552012005000151. Epub 2014 May 2.
PubMed 24838809Peng DM, Zampi JD, Smith SM, Yu S, Rottach N, Lowery R, Lim HM, Riegger LQ, Schumacher KR, Rocchini A. Acute Hemodynamic Effects of Negative Extrathoracic Pressure in Fontan Physiology. Pediatr Cardiol. 2019 Dec;40(8):1633-1637. doi: 10.1007/s00246-019-02197-x. Epub 2019 Aug 29.
PubMed 31468061Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.
PubMed 27741132
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pulmonary Rehabilitation and Thoracic Fluid Capacity: One-year Follow-up of Observation Research
- ClinicalTrials.gov ID
- NCT05240989
- Acronym / sponsor ID
- PL-202008027-M
- Conditions
- COPD Received PR
- Keywords
- pulmonary rehabilitation, negative pressure ventilation, electrical cardiometry, chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Feb 2022 (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.
To study the effects of lung rehabilitation on the heart's hemodynamic performance of patients with chronic bidirectional lung disease when performing routine and regular PR, and found that the effects of lung rehabilitation on the heart mechanism and patients long-term quality of life research.
Detailed description
This study will be conducted in the Pulmonary Rehabilitation Treatment Room on the 6th floor of the Affiliated University Hospital. The acceptance conditions are: (1) treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic, and (2) signing of the subject's consent; exclusion conditions: (1) tracheostomized patients, (2) patients who cannot perform conventional lung rehabilitation, (3) patients who use respirators at home.
The study is a prospective observational study. It is expected to include a total of 25 subjects. The study will be implemented for one year from the date of IRB adoption. Before performing PR treatment, performed the 6th and 12th Every month, routine lung function, six-minute walking tests, and non-invasive cardiac output measurements are performed. The main results are: cardiac hemodynamic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of Affiliated University Hospital
Key inclusion criteria (2 listed)
- treatment of chronic pulmonary obstructive pulmonary disease in the lung rehabilitation clinic
- signing of the subject's consent
Key exclusion criteria (3 listed)
- gas-cut patients
- patients who cannot perform conventional lung rehabilitation
- patients who use respirators at home
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 rehabilitationone-year regular lung rehabilitation treatment and control the intensive monitoring of hemodynamic parameters | Procedure or surgery | – |
Primary outcome
cardiac hemodynamic parameters
Time frame: one year
heart rate (HR)
cardiac hemodynamic parameters
Time frame: one year
blood pressure (BP)
cardiac hemodynamic parameters
Time frame: one year
stroke volume (SV)
cardiac hemodynamic parameters
Time frame: one year
cardiac output (CO)
cardiac hemodynamic parameters
Time frame: one year
total peripheral resistance (TPR)
3 secondary outcomes
mMRC (Modified Medical Research Council) Dyspnea Scale Dyspnea Scale
Time frame: one year
Chronic Respiratory Disease Questionnaire
Time frame: one year
COPD Assessment Test
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 24838809Farias CC, Resqueti V, Dias FA, Borghi-Silva A, Arena R, Fregonezi GA. Costs and benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease: a randomized controlled trial. Braz J Phys Ther. 2014 Mar-Apr;18(2):165-73. doi: 10.1590/s1413-35552012005000151. Epub 2014 May 2.
- Background: PubMed 31468061Peng DM, Zampi JD, Smith SM, Yu S, Rottach N, Lowery R, Lim HM, Riegger LQ, Schumacher KR, Rocchini A. Acute Hemodynamic Effects of Negative Extrathoracic Pressure in Fontan Physiology. Pediatr Cardiol. 2019 Dec;40(8):1633-1637. doi: 10.1007/s00246-019-02197-x. Epub 2019 Aug 29.
- Background: PubMed 27741132Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.
- Individual participant dataSharing planned: Undecided
Related trials for COPD Received PR
Not yet recruiting
Efficacy Of Inpatient Pulmonary Rehabilitation Program In Elderly Patients With Acute Exacerbation Of COPD
COPD Received PR, Elderly (People Aged 65 or More)
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.
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 COPD Received PR, run by Fu Jen Catholic University 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 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. 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 Ke-Yun Chao, M.Sc (+886952909103, ck_qq@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac hemodynamic parameters (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240989, which also lists 3 linked publications.
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 26 Oct 2022.