Chronic Pulmonary DiseaseNCT05760352
Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease
A study testing Eccentric bike and Helmet ventilation in people with Chronic Pulmonary Disease, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Pulmonary Disease
- What is being tested?
- Eccentric bike and Helmet ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 2023to 29 Feb 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age between 20 and 80 years
- Diagnosed with chronic respiratory diseases
- Having undergone pulmonary rehabilitation for more than 3 months
Who cannot join
- Existing of tracheostomy
- Those who use oxygen therapy or ventilator at home
- Severe left heart failure (NYHA III-IV)
- Neuromuscular disease
- Acute exacerbation within the past three months
- Those who are unable to cooperate with the cardiopulmonary exercise test
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
About this study
Official title: Comparison of Multiple Methods of Exercise Training for Accessing Maximal Oxygen Consumption, Skeletal Muscle Oxygen Saturation, and Cardiopulmonary Outcomes in Patients With Chronic Respiratory Disease
The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.
Read the detailed description
Background： Chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. Patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. Symptoms of COPD may contribute to activity restriction, deconditioning, and exercise intolerance. Pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. However, the optimal exercise training modality is remaining unclear.
Study Design： This is a one-year, single-centre, prospective randomized controlled trial
Methods： The investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). All participants will receive a graded exercise test, then followed a 9-weeks of exercise training. After 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. Physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded.
Effect： After 9 weeks' exercise training, VO2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation.
Key words： Pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease
- Conditions
- Chronic Pulmonary Disease
- Being tested
- Eccentric bike, Helmet ventilation
- Keywords
- Pulmonary rehabilitation, Eccentric cycling exercise, Helmet ventilation, Chronic respiratory disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric bikeDevice
Received eccentric cycling exercise
Helmet ventilationDevice
Using helmet ventilation during eccentric cycling exercise
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Self-paced exercise |
| Intervention Group: eccentric cycling exercise | Experimental | Received eccentric cycling exercise Receives: Device: Eccentric bike |
| Intervention Group: eccentric cycling exercise with helmet ventilation | Experimental | Eccentric cycling exercise combined with helmet ventilation Receives: Device: Eccentric bike; Device: Helmet ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak % of oxygen consumption
To observe the maximum exercise performance
Measured: 9 weeks
Secondary outcomes (5)
Heart rate, b/m
Cardiac hemodynamic parameter
Measured: 9 weeks
Respiratory rate, b/m
Pulmonary parameter
Measured: 9 weeks
Mean arterial blood pressure, mmHg
Cardiac hemodynamic parameter
Measured: 9 weeks
FEV1/FVC, %
Pulmonary function
Measured: 9 weeks
Saturation of Peripheral Oxygen(SpO2), %
Blood oxygenation
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start14 Apr 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
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
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760352
- Sponsor's protocol ID
- FJUH111193
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
PubMed 41290215
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multiple Methods of Exercise Training for Accessing Maximal Oxygen Consumption, Skeletal Muscle Oxygen Saturation, and Cardiopulmonary Outcomes in Patients With Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT05760352
- Acronym / sponsor ID
- FJUH111193
- Conditions
- Chronic Pulmonary Disease
- Keywords
- Pulmonary rehabilitation, Eccentric cycling exercise, Helmet ventilation, Chronic respiratory disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 8 Mar 2023 (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 present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.
Detailed description
Background： Chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. Patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. Symptoms of COPD may contribute to activity restriction, deconditioning, and exercise intolerance. Pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. However, the optimal exercise training modality is remaining unclear.
Study Design： This is a one-year, single-centre, prospective randomized controlled trial
Methods： The investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). All participants will receive a graded exercise test, then followed a 9-weeks of exercise training. After 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. Physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded.
Effect： After 9 weeks' exercise training, VO2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation.
Key words： Pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Self-paced exercise |
| Intervention Group: eccentric cycling exercise | Experimental | Device: Eccentric bikeReceived eccentric cycling exercise |
| Intervention Group: eccentric cycling exercise with helmet ventilation | Experimental | Device: Eccentric bike, Device: Helmet ventilationEccentric cycling exercise combined with helmet ventilation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 80 years
- Diagnosed with chronic respiratory diseases
- Having undergone pulmonary rehabilitation for more than 3 months
Key exclusion criteria (6 listed)
- Existing of tracheostomy
- Those who use oxygen therapy or ventilator at home
- Severe left heart failure (NYHA III-IV)
- Neuromuscular disease
- Acute exacerbation within the past three months
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 |
|---|---|---|
| Eccentric bikeReceived eccentric cycling exercise | Device | Intervention Group: eccentric cycling exercise, Intervention Group: eccentric cycling exercise with helmet ventilation |
| Helmet ventilationUsing helmet ventilation during eccentric cycling exercise | Device | Intervention Group: eccentric cycling exercise with helmet ventilation |
Primary outcome
Peak % of oxygen consumption
Time frame: 9 weeks
To observe the maximum exercise performance
5 secondary outcomes
Heart rate, b/m
Time frame: 9 weeks
Respiratory rate, b/m
Time frame: 9 weeks
Mean arterial blood pressure, mmHg
Time frame: 9 weeks
FEV1/FVC, %
Time frame: 9 weeks
Saturation of Peripheral Oxygen(SpO2), %
Time frame: 9 weeks
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 12 Mar 2024.
- Derived from this study: PubMed 41290215Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
- 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.
Ke-Yun Chao, PhD principal investigator
Fu Jen Catholic University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric bike and Helmet ventilation in people with Chronic Pulmonary Disease, 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 3 inclusion and 6 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 12 Mar 2024. 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?
Peak % of oxygen consumption (time frame: 9 weeks). 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 NCT05760352, which also lists 1 linked publication.
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 12 Mar 2024.