Chronic Obstructive Pulmonary DiseaseNCT06756646
Exploring the Effects of Aerobic Exercise Combined With BFRT on Patients With COPD
A study testing Aerobic exercise intervention, Disease and exercise suggestion and Blood flow restriction (BFR) intervention in people with Chronic Obstructive Pulmonary Disease, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in COPD patients. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Aerobic exercise intervention, Disease and exercise suggestion and Blood flow restriction (BFR) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2024to 31 Dec 2030
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD classified as levels 2-4.
- Stable condition without worsening in the past three months.
- No participation in any rehabilitation program within the past six months.
- Ability to understand and follow verbal commands and cooperate with an exercise training program.
Who cannot join
- Unconscious or unable to cooperate with the evaluator.
- Hospitalization due to acute illness within the past three months.
- Severe joint diseases or history of lower limb surgery.
- Severe cardiovascular disease (e.g., presence of a cardiac pacemaker or acute myocardial infarction within the past six months).
- Dependence on oxygen supply.
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
National Cheng Kung University Hostipal
Tainan, Taiwan, 701
Kun-Ling Tsai, PhD, 062353535 ext. 6219, kunlingtsai@mail.ncku.edu.tw
About this study
Official title: Exploring the Effects of Aerobic Exercise Combined With Blood Flow Restriction Training on Exercise Capacity, Cardiopulmonary Functions, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in COPD patients.
Read the detailed description
The systemic effects of Chronic Obstructive Pulmonary Disease (COPD) can precipitate a series of complications, including cardiovascular disorders, muscle atrophy, and osteoporosis. These comorbid conditions often result in decreased physical activity and suboptimal physical fitness, compelling patients to lead a sedentary lifestyle to mitigate exercise-induced dyspnea. Addressing the limitations in exercise tolerance remains a critical therapeutic goal in the treatment of COPD. According to research, exercise intolerance is caused by both poor pulmonary function and associated skeletal muscle dysfunction. Blood flow restriction training, a new rehabilitation technique, has shown promise in improving muscular strength at lower exercise intensities and in shorter timeframes, presenting a fresh approach to COPD rehabilitation.
The research aims to investigate the impact of incorporating blood flow restriction training into a holistic aerobic exercise program on exercise capacity and quality of life among patients with COPD. The findings are intended to clarify the potential of this innovative training technique as a supplementary therapeutic strategy in the management of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Aerobic exercise intervention, Disease and exercise suggestion, Blood flow restriction (BFR) intervention
- Keywords
- Blood flow restriction training, 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.
Aerobic exercise interventionBehavioural
The aerobic exercise intervention will utilize an ergometer. The program will be conducted 2-3 times per week over a 3-month period.
Disease and exercise suggestionBehavioural
The participants will be provided by educational program about COPD self-care and home-based exercise approach.
Blood flow restriction (BFR) interventionBehavioural
Blood flow restriction (BFR) intervention will combine aerobic exercise on the ergometer with BFR training. The program will be conducted 2-3 times per week over a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| Usual care group | Active comparator | The Usual care group will receive COPD and exercise-related education. Receives: Behavioral: Disease and exercise suggestion |
| Aerobic exercise group-cycling | Experimental | The aerobic exercise group will receive cycling training intervention 2-3 times per week for 2 months. Receives: Behavioral: Aerobic exercise intervention |
| BFR group-cycling + BFR | Experimental | The BFR group will receive cycling training combined with BFR intervention 2-3 times per week for 2 months. Receives: Behavioral: Blood flow restriction (BFR) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption (VO2)
Oxygen consumption examined by cardiopulmonary exercise test
Measured: Change from baseline (0 week) to follow up (20 weeks)
Functional capacity
Functional capacity examined by 6MWT
Measured: Change from baseline (0 week) to follow up (20 weeks)
Secondary outcomes (7)
Heart Rate Variability
Heart Rate Variability examined by autonomic nervous system
Measured: Change from baseline (0 week) to follow up (20 weeks)
Pulmonary function test
Pulmonary function test examined by spirometer. Spirometry is a physiological test that measures the ability to inhale and exhale air over time. The main spirometry results are forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio.
Measured: Change from baseline (0 week) to follow up (20 weeks)
Maximum respiratory pressure
Maximum respiratory pressure examined by pressure meter
Measured: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-I)
Quality of life score examined by mMRC Questionnaire.
Measured: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-II)
COPD Assessment Test (CAT) questionaire
Measured: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-III)
St George's Respiratory Questionnaire (SGRQ)
Measured: Change from baseline (0 week) to follow up (20 weeks)
Diaphragm capacity
Diaphragm capacity examined by diaphragmatic ultrasound
Measured: Change from baseline (0 week) to follow up (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start20 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
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 Obstructive 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ling Tsai, National Cheng Kung University
- Investigators
- Kun-Ling Tsai, Ph.D., Principal investigator, Department of Physical Therapy, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756646
- Sponsor's protocol ID
- B-ER-113-298
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing plan will be decided after summarized data being published.
Publications
Huang YT, Cheng HC, Yang HL, Hung CH, Wu TY, Kuo CW, Wang SY, Tsai KL. Efficacy of blood flow restriction combined with low-intensity aerobic training in patients with COPD: Study protocol for the BREATH randomized controlled trial. Contemp Clin Trials. 2026 Oct 22:108515. doi: 10.1016/j.cct.2026.108515. Online ahead of print.
PubMed 42914006
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Aerobic Exercise Combined With Blood Flow Restriction Training on Exercise Capacity, Cardiopulmonary Functions, and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06756646
- Acronym / sponsor ID
- B-ER-113-298
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Blood flow restriction training, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Jan 2025 (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.
Investigate the effects of exercise training on the cardiopulmonary function and exercise capacity in COPD patients.
Detailed description
The systemic effects of Chronic Obstructive Pulmonary Disease (COPD) can precipitate a series of complications, including cardiovascular disorders, muscle atrophy, and osteoporosis. These comorbid conditions often result in decreased physical activity and suboptimal physical fitness, compelling patients to lead a sedentary lifestyle to mitigate exercise-induced dyspnea. Addressing the limitations in exercise tolerance remains a critical therapeutic goal in the treatment of COPD. According to research, exercise intolerance is caused by both poor pulmonary function and associated skeletal muscle dysfunction. Blood flow restriction training, a new rehabilitation technique, has shown promise in improving muscular strength at lower exercise intensities and in shorter timeframes, presenting a fresh approach to COPD rehabilitation.
The research aims to investigate the impact of incorporating blood flow restriction training into a holistic aerobic exercise program on exercise capacity and quality of life among patients with COPD. The findings are intended to clarify the potential of this innovative training technique as a supplementary therapeutic strategy in the management of COPD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care group | Active comparator | Behavioral: Disease and exercise suggestionThe Usual care group will receive COPD and exercise-related education. |
| Aerobic exercise group-cycling | Experimental | Behavioral: Aerobic exercise interventionThe aerobic exercise group will receive cycling training intervention 2-3 times per week for 2 months. |
| BFR group-cycling + BFR | Experimental | Behavioral: Blood flow restriction (BFR) interventionThe BFR group will receive cycling training combined with BFR intervention 2-3 times per week for 2 months. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD classified as levels 2-4.
- Stable condition without worsening in the past three months.
- No participation in any rehabilitation program within the past six months.
- Ability to understand and follow verbal commands and cooperate with an exercise training program.
Key exclusion criteria (5 listed)
- Unconscious or unable to cooperate with the evaluator.
- Hospitalization due to acute illness within the past three months.
- Severe joint diseases or history of lower limb surgery.
- Severe cardiovascular disease (e.g., presence of a cardiac pacemaker or acute myocardial infarction within the past six months).
- Dependence on oxygen supply.
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 |
|---|---|---|
| Aerobic exercise interventionThe aerobic exercise intervention will utilize an ergometer. The program will be conducted 2-3 times per week over a 3-month period. | Behavioural | Aerobic exercise group-cycling |
| Disease and exercise suggestionThe participants will be provided by educational program about COPD self-care and home-based exercise approach. | Behavioural | Usual care group |
| Blood flow restriction (BFR) interventionBlood flow restriction (BFR) intervention will combine aerobic exercise on the ergometer with BFR training. The program will be conducted 2-3 times per week over a 3-month period. | Behavioural | BFR group-cycling + BFR |
Primary outcome
Oxygen consumption (VO2)
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Oxygen consumption examined by cardiopulmonary exercise test
Functional capacity
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Functional capacity examined by 6MWT
7 secondary outcomes
Heart Rate Variability
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Pulmonary function test
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Maximum respiratory pressure
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-I)
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-II)
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Quality of life score (COPD-related questionnaire-III)
Time frame: Change from baseline (0 week) to follow up (20 weeks)
Diaphragm capacity
Time frame: Change from baseline (0 week) to follow up (20 weeks)
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 21 Oct 2026.
- Derived from this study: PubMed 42914006Huang YT, Cheng HC, Yang HL, Hung CH, Wu TY, Kuo CW, Wang SY, Tsai KL. Efficacy of blood flow restriction combined with low-intensity aerobic training in patients with COPD: Study protocol for the BREATH randomized controlled trial. Contemp Clin Trials. 2026 Oct 22:108515. doi: 10.1016/j.cct.2026.108515. Online ahead of print.
- Individual participant dataSharing planned: No. IPD sharing plan will be decided after summarized data being published.
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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.
Kun-Ling Tsai, Ph.D. principal investigator
Department of Physical Therapy, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise intervention, Disease and exercise suggestion and Blood flow restriction (BFR) intervention in people with Chronic Obstructive Pulmonary Disease, run by National Cheng Kung 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 4 inclusion and 5 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 21 Oct 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 Kun-Ling Tsai, Ph.D. (886-6-2353535 ext. 5078, kunlingtsai@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption (VO2) (time frame: Change from baseline (0 week) to follow up (20 weeks)). The study lists 2 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 NCT06756646, 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 21 Oct 2026.