COPDNCT06168266
Effects of Eccentric Exercise Training in Patients With COPD
A study testing Eccentric bike and conventional group in people with COPD, run by Fu Jen Catholic University at 1 site in Taiwan.
Trial summary
The goal of this study is to design eccentric exercise strategies for COPD patients to comprehensively improve their cardiopulmonary/muscular fitness, immune and hemorheological functions, and quality of life, thereby improving the prognosis of their disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- Eccentric bike and conventional group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Dec 2023to 30 Dec 2027
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone pulmonary rehabilitation for more than 3 months
- Sign the written informed consent form
- FEV1/FVC < 0.70
- Approval for exercise training granted by a specialist physician's assessment
- Specialist physician's approval for exercise training
Who cannot join
- Existing of tracheostomy
- Those who use oxygen therapy or ventilator at home
- Severe 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
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- Taking anticoagulant medications
- Other conditions restricting exercise for over a year
- Recent or planned significant cardiovascular surgery or intervention
- Current or planned pregnancy within the next year
- Planned heart transplant within the next six months
- Heart failure due to uncorrectable valvular heart disease, congenital heart disease or obstructive cardiomyopathy
- Inadequate ICD settings for exercise heart rate
- Other exercise contraindications: unstable angina, uncontrolled blood pressure, orthostatic hypotension with symptoms, severe aortic stenosis, acute discomfort or fever, uncontrolled arrhythmias, uncompensated heart failure, acute pericarditis or myocarditis, recent thrombosis or thrombophlebitis, resting ST-segment deviation, uncontrolled diabetes, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Fu Jen Catholic University Hospital, Fu Jen Catholic University
New Taipei City, 24352
Ke-Yun Chao, PhD, +886-905-301-879, ck_qq@hotmail.com
Ke-Yun Chao, PhD
About this study
Official title: Effects of Smart Eccentric Exercise Training on Lymphocyte Immunity and Erythrocyte Rheology in Patients With Chronic Obstructive Pulmonary Disease
The goal of this study is to design eccentric exercise strategies for COPD patients to comprehensively improve their cardiopulmonary/muscular fitness, immune and hemorheological functions, and quality of life, thereby improving the prognosis of their disease.
Read the detailed description
Background: The pathological process of COPD is often accompanied by a decrease in the number and distribution of immune cells in the blood, resulting in immune dysfunction, persistent, multiple infections, and systemic inflammation. Furthermore, the high oxidative stress induced by COPD may also depress the rheological properties of erythrocytes and cause secondary circulatory dysfunction. However, ventilatory limitation and decreased muscle function in COPD patients limit the patients to perform higher-effort exercise therapy. Compared with concentric exercise, eccentric exercise can effectively improve health-related physical fitness and quality of life under lower cardiorespiratory and metabolic loads.
Study Design: This is a three-year project in single center; COPD patients with GOLD grades are recruited in the first year, and then divided into four groups according to GOLD severity grades, and 50 subjects are expected to be recruited; In the second and third year, 120 COPD patients with GOLD grades were recruited.
Methods: This study is expected to recruit 170 subjects, and it will be conducted in the pulmonary rehabilitation treatment room. In the first year, 50 COPD patients with GOLD grade will be recruited, and 20 mL of the venous blood will be drawn during rest for follow-up blood analysis. After that, each subject will perform a serious of functional test, including Six-minute walk test, Timed up-and-go test, Stairs ascending and descending walking time, cardiopulmonary exercise test and isokinetic muscle test. In the second and third year, 60 COPD patients will be recruited respectively, and they will be randomly assigned to the eccentric exercise training and control groups (general care group), each group will carry out the experiment including three stages: control period, training period (and general care group) and maintenance period. During the training period, the eccentric exercise training group will perform 36 eccentric cycling exercises with progressive exercise intensity for 12 weeks, each session about 40 minutes (including 5-min warm-up, 30-min exercise and 5-min relaxation). In the control period, maintenance period and general care group, no exercise intervention will be performed; and in these three experimental periods, 4 functional tests and 4 resting blood draws will be performed.
Effect: This project expects that after 12 weeks of intelligent eccentric exercise training, COPD patients will effectively improve their health-related fitness and quality of life under lower cardiorespiratory and metabolic loads, and will benefit from peripheral blood lymphocytes. Changes in lymphocyte immunity and erythrocyte rheology, to classfy the biological indicators of the course of COPD.
Key words: COPD, Eccentric Exercise Training, Lymphocytes, Mitochondria, Erythrocytes, Rheology
- Conditions
- COPD
- Being tested
- Eccentric bike, conventional group
- Keywords
- COPD, Eccentric Exercise Training, Lymphocytes, Mitochondria, Erythrocytes, Rheology
- 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.
Eccentric bikeDevice
Received eccentric cycling exercise
conventional groupOther
Received conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Undergoing conventional treatment Receives: Other: conventional group |
| Intervention Group: eccentric cycling exercise | Experimental | Received eccentric cycling exercise Receives: Device: Eccentric bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary oxygen consumption
to observe the maximum exercise performance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start13 Dec 2023
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 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
- Investigators
- Ke-Yun Chao, PhD, Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168266
- Sponsor's protocol ID
- FJUH111246
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2023
- Last updated
- 12 Feb 2026
- Results posted
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smart Eccentric Exercise Training on Lymphocyte Immunity and Erythrocyte Rheology in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06168266
- Acronym / sponsor ID
- FJUH111246
- Conditions
- COPD
- Keywords
- COPD, Eccentric Exercise Training, Lymphocytes, Mitochondria, Erythrocytes, Rheology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fu Jen Catholic UniversityUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Dec 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 goal of this study is to design eccentric exercise strategies for COPD patients to comprehensively improve their cardiopulmonary/muscular fitness, immune and hemorheological functions, and quality of life, thereby improving the prognosis of their disease.
Detailed description
Background: The pathological process of COPD is often accompanied by a decrease in the number and distribution of immune cells in the blood, resulting in immune dysfunction, persistent, multiple infections, and systemic inflammation. Furthermore, the high oxidative stress induced by COPD may also depress the rheological properties of erythrocytes and cause secondary circulatory dysfunction. However, ventilatory limitation and decreased muscle function in COPD patients limit the patients to perform higher-effort exercise therapy. Compared with concentric exercise, eccentric exercise can effectively improve health-related physical fitness and quality of life under lower cardiorespiratory and metabolic loads.
Study Design: This is a three-year project in single center; COPD patients with GOLD grades are recruited in the first year, and then divided into four groups according to GOLD severity grades, and 50 subjects are expected to be recruited; In the second and third year, 120 COPD patients with GOLD grades were recruited.
Methods: This study is expected to recruit 170 subjects, and it will be conducted in the pulmonary rehabilitation treatment room. In the first year, 50 COPD patients with GOLD grade will be recruited, and 20 mL of the venous blood will be drawn during rest for follow-up blood analysis. After that, each subject will perform a serious of functional test, including Six-minute walk test, Timed up-and-go test, Stairs ascending and descending walking time, cardiopulmonary exercise test and isokinetic muscle test. In the second and third year, 60 COPD patients will be recruited respectively, and they will be randomly assigned to the eccentric exercise training and control groups (general care group), each group will carry out the experiment including three stages: control period, training period (and general care group) and maintenance period. During the training period, the eccentric exercise training group will perform 36 eccentric cycling exercises with progressive exercise intensity for 12 weeks, each session about 40 minutes (including 5-min warm-up, 30-min exercise and 5-min relaxation). In the control period, maintenance period and general care group, no exercise intervention will be performed; and in these three experimental periods, 4 functional tests and 4 resting blood draws will be performed.
Effect: This project expects that after 12 weeks of intelligent eccentric exercise training, COPD patients will effectively improve their health-related fitness and quality of life under lower cardiorespiratory and metabolic loads, and will benefit from peripheral blood lymphocytes. Changes in lymphocyte immunity and erythrocyte rheology, to classfy the biological indicators of the course of COPD.
Key words: COPD, Eccentric Exercise Training, Lymphocytes, Mitochondria, Erythrocytes, Rheology
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: conventional groupUndergoing conventional treatment |
| Intervention Group: eccentric cycling exercise | Experimental | Device: Eccentric bikeReceived eccentric cycling exercise |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having undergone pulmonary rehabilitation for more than 3 months
- Sign the written informed consent form
- FEV1/FVC < 0.70
- Approval for exercise training granted by a specialist physician's assessment
- Specialist physician's approval for exercise training
Key exclusion criteria (14 listed)
- Existing of tracheostomy
- Those who use oxygen therapy or ventilator at home
- Severe 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 |
| conventional groupReceived conventional treatment | Other | Control group |
Primary outcome
cardiopulmonary oxygen consumption
Time frame: 12 weeks
to observe the maximum exercise performance
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 12 Feb 2026.
- 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.
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 conventional group in people with COPD, 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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?
Contact Ke-Yun Chao, PhD (+886905301879, C00152@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiopulmonary oxygen consumption (time frame: 12 weeks). 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 12 Feb 2026.