Obstructive Airway DiseaseNCT06332820
In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise
An observational study of Obstructive Airway Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Airway Disease
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2024to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Obstructive airway disease patients
Who may be able to join
- Age > 18
Who cannot join
- Coronary angiography via femoral artery in recent 3 days
- Central venous catheter in femoral vein
- The patient couldn't walk over 20 meters
- Lower limb arthropathy
- Unclear consciousness and the patient couldn't cooperate well
- SPO2 < 85%
Show all 10Show fewer
- Acute coronary syndrome in recent 1 month
- Respiratory failure or unstable hemodynamics
- Pneumothorax or bronchial fistula
- Acute exacerbation in recent 3 months
Trial locations and contacts
1 site in 1 country.
About this study
The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease.
Read the detailed description
Obstructive airway disease is defined as forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) <0.7. It includes chronic obstructive pulmonary disease (COPD), asthma, lymphangioleiomyomatosis (LAM) and bronchiolitis obliterans syndrome. Pulmonary rehabilitation is widely utilized in patients with obstructive airway disease. Comprehensive intervention based on a thorough patient assessment followed by patient-tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people. The exercise prescription for pulmonary rehabilitation is often determined based on exercise capacity. The exercise capacity includes peaked VO2 (oxygen consumption), peaked work rate, and anaerobic threshold. They are all measured in cardiopulmonary exercise test (CPET). However, patients often struggle to achieve training goals due to severe dyspnea. Dynamic hyperinflation is a common cause of shortness of breath on exertion in obstructive airway disease.
Generally, end-expiratory lung volume (EELV) is relative constant during exercise. Inspiratory capacity (IC) is increasing during exercise. The IC maneuver is used to monitor exercise-induced dynamic hyperinflation. Dynamic hyperinflation caused by air trapping, which increases residual air volume, is a common cause of shortness of breath on exertion in obstructive lung disease. There are many diagnostic criteria, including a decrease in dynamic IC of >140mL, a decrease of ≥5% in IC during maximal exercise, or a decrease of ≥10% in IC during maximal exercise. In a prospective observational study, dynamic hyperinflation occurred at a higher prevalence (55%) in patients with LAM. Dynamic hyperinflation was associated with a reduction in FEV1 and higher dyspnea intensity at exercise cessation (R = -0.53, P-value < 0.001). COPD patients develop dynamic hyperinflation during symptom-limited incremental work exercise with cycle ergometer. The increase in EELV seems to be the best predictor of dyspnea.
The pedaling rate is typically set at 60 revolutions per minute in National Taiwan University Hospital. The average respiratory rate for a total of 31 patients is 29 breaths per minute. 2019 European respiratory society suggested that maintaining over a wide range of pedaling rates (40-70 revolutions per minute) in CPET. The evidence of the optimal pedaling rate during exercise obstructive airway disease is limited. The current consensus remains inconclusive on whether a lower pedaling rate will result in a reduction of breathing speed, subsequently improving dynamic hyperinflation, and ultimately leading to an improvement in exercise capacity. This prospective observational study, employing a crossover design, aims to investigate the impact of pedaling rate during exercise tests on dynamic hyperinflation and exercise capacity in individuals with obstructive airway disease.
- Conditions
- Obstructive Airway Disease
- Keywords
- Obstructive airway disease, Cardiopulmonary exercise test
- Medical subject headings
- Lung Diseases, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory capacity during exercise
Inspiratory capacity during exercise
Measured: During the cardiopulmonary exercise test
Secondary outcomes (1)
Change of FEV1 and symptoms
Change of FEV1 and symptoms
Measured: During the cardiopulmonary exercise test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start20 Mar 2024
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Airway 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting-Yu Liao, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332820
- Sponsor's protocol ID
- 202401226RINB
- Status last verified
- Mar 2024
- First submitted
- 20 Mar 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise
- ClinicalTrials.gov ID
- NCT06332820
- Acronym / sponsor ID
- 202401226RINB
- Conditions
- Obstructive Airway Disease
- Keywords
- Obstructive airway disease, Cardiopulmonary exercise test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Mar 2024 (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.
The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease.
Detailed description
Obstructive airway disease is defined as forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) <0.7. It includes chronic obstructive pulmonary disease (COPD), asthma, lymphangioleiomyomatosis (LAM) and bronchiolitis obliterans syndrome. Pulmonary rehabilitation is widely utilized in patients with obstructive airway disease. Comprehensive intervention based on a thorough patient assessment followed by patient-tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people. The exercise prescription for pulmonary rehabilitation is often determined based on exercise capacity. The exercise capacity includes peaked VO2 (oxygen consumption), peaked work rate, and anaerobic threshold. They are all measured in cardiopulmonary exercise test (CPET). However, patients often struggle to achieve training goals due to severe dyspnea. Dynamic hyperinflation is a common cause of shortness of breath on exertion in obstructive airway disease.
Generally, end-expiratory lung volume (EELV) is relative constant during exercise. Inspiratory capacity (IC) is increasing during exercise. The IC maneuver is used to monitor exercise-induced dynamic hyperinflation. Dynamic hyperinflation caused by air trapping, which increases residual air volume, is a common cause of shortness of breath on exertion in obstructive lung disease. There are many diagnostic criteria, including a decrease in dynamic IC of >140mL, a decrease of ≥5% in IC during maximal exercise, or a decrease of ≥10% in IC during maximal exercise. In a prospective observational study, dynamic hyperinflation occurred at a higher prevalence (55%) in patients with LAM. Dynamic hyperinflation was associated with a reduction in FEV1 and higher dyspnea intensity at exercise cessation (R = -0.53, P-value < 0.001). COPD patients develop dynamic hyperinflation during symptom-limited incremental work exercise with cycle ergometer. The increase in EELV seems to be the best predictor of dyspnea.
The pedaling rate is typically set at 60 revolutions per minute in National Taiwan University Hospital. The average respiratory rate for a total of 31 patients is 29 breaths per minute. 2019 European respiratory society suggested that maintaining over a wide range of pedaling rates (40-70 revolutions per minute) in CPET. The evidence of the optimal pedaling rate during exercise obstructive airway disease is limited. The current consensus remains inconclusive on whether a lower pedaling rate will result in a reduction of breathing speed, subsequently improving dynamic hyperinflation, and ultimately leading to an improvement in exercise capacity. This prospective observational study, employing a crossover design, aims to investigate the impact of pedaling rate during exercise tests on dynamic hyperinflation and exercise capacity in individuals with obstructive airway disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive airway disease patients
Key inclusion criteria (1 listed)
- Age > 18
Key exclusion criteria (10 listed)
- Coronary angiography via femoral artery in recent 3 days
- Central venous catheter in femoral vein
- The patient couldn't walk over 20 meters
- Lower limb arthropathy
- Unclear consciousness and the patient couldn't cooperate well
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
Inspiratory capacity during exercise
Time frame: During the cardiopulmonary exercise test
Inspiratory capacity during exercise
1 secondary outcome
Change of FEV1 and symptoms
Time frame: During the cardiopulmonary exercise test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Ting-Yu Liao study chair
National Taiwan University Hospital
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 Obstructive Airway 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 1 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Inspiratory capacity during exercise (time frame: During the cardiopulmonary exercise test). 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 Feb 2025.