Chronic Obstructive Pulmonary DiseaseNCT06963333
Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance
A study testing Breathing guided exercise and Flat walking training in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Breathing guided exercise and Flat walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 31 Jul 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD in stable stage
- Patients with grade 2 to 4 lung function
- Age 40~80 years old
- Be able to use smart phones, computers and other devices independently or with the help of family members during home training
- Volunteer for treatment and sign an informed consent form
Who cannot join
- Pregnant or lactating women and patients with recent pregnancy plans
- Delirious, dementia, all kinds of mental illness
- Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years
- Patients with severe osteoarthropathy or osteoporosis, unstable fractures
- Patients with severe visual impairment that cannot be improved or who have epilepsy or vertigo and cannot use VR devices
- Patients with progressive neuromuscular disease
Show all 11Show fewer
- Patients with pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism and other pulmonary diseases
- Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.)
- Patients with severe liver disease (cirrhosis, portal hypertension and bleeding caused by esophageal and gastric varices, etc.) and severe kidney disease (dialysis, kidney transplantation, etc.)
- Participants who were participating in other clinical trials within 1 month prior to enrollment
- People who stay in bed for a long time for various reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Hailong Zhang, doctor, +86-0371-66248624, zhanghailong6@126.com
About this study
Official title: Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance: A Multicenter, Randomized, Controlled Clinical Trial
This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease in China. Based on the digital management platform, 548 patients with COPD in stable stage were selected as the research objects. A multi-center, randomized, controlled clinical trial design was adopted to scientifically evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability and reveal its mechanism of action. A breath-guided rehabilitation program based on intelligent iot and remote home was established and promoted to improve exercise ability and reduce acute exacerbation. To form high-quality clinical evidence, and realize tracking management, real-time evaluation and effect evaluation throughout rehabilitation.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Breathing guided exercise, Flat walking training
- Keywords
- Stable stage of chronic obstructive pulmonary disease, Tele-home rehabilitation, randomized controlled trial
- 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.
Breathing guided exerciseBehavioural
Breathing guided exercise are divided into six sections: relaxing standing, two fields breathing, regulating lung and kidney, turning side finger, running kidney hall and nourishing qi and collecting gong. Exercise time: 5 days a week, 1 to 2 times a day, a total of 24 weeks.
Flat walking trainingBehavioural
Flat walking training can be performed either outdoors or on flat indoor surfaces at a steady pace of 80 to 120 steps per minute for at least 30 minutes each session, raising the heart rate to the target range and maintaining it for over 10 minutes. This should be done 3 to 5 times a week, with 1 to 2 sessions each day, for a total of 24 weeks. The intensity of the exercise is moderate. The target heart rate based on heart rate reserve is calculated as (maximum heart rate during exercise - resting heart rate) × (40-60)% + resting heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Breathing guided rehabilitation group | Experimental | The breathing guided rehabilitation group will receive conventional western medicine treatment and breathing guided exercise which consists of training and patient education. They will be evaluated with some tests for the study. Receives: Behavioral: Breathing guided exercise |
| Flat ground walking training | Active comparator | The flat ground walking training group will receive conventional western medicine treatment and flat walking training which consists of training and patient education. They will be evaluated with some tests for the study. Receives: Behavioral: Flat walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Distance Test (6MWD)
The 6-minute walking distance of the two groups was calculated
Measured: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Secondary outcomes (11)
Incidence of acute exacerbation
The proportion of patients with ≥1 acute exacerbation in each group during the study period was recorded. If the interval between two acute exacerbations was within 5 days, it was considered as 1 acute exacerbation.
Measured: Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Degree of breathing difficulty
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Borg dyspnea score
Borg dyspnea score is a 10-point (0-10) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "10" means most severe dyspnea perception.
Measured: Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The COPD Assessment Test(CAT)
The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.
Measured: Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Lung function
Forced Vital Capacity (FVC)、Forced Expiratory Volume in One Second (FEV1) and Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) were mainly used for lung function evaluation.
Measured: Changes in baseline Lung function test at weeks 0 and 24 of the treatment.
Anxiety Scale
The Self-Rating Anxiety Scale (SAS) was used to assess the anxiety state of patients. It is a questionnaire consisting of 20 items, with a score range of 1 to 4. The higher the value, the more severe the anxiety state of the patients.
Measured: Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Depression Scale
The Self-Rating Depression Scale (SDS) was used to assess the depressive state of patients. It is a questionnaire consisting of 20 items, with a score range of 1 to 4. The higher the value, the more severe the depressive state of the patients.
Measured: Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Clinical symptom assessment questionnaire (CCQ)
The Clinical symptom assessment questionnaire (CCQ) is a self-administered questionnaire that measures healthrelated quality of life. It is an 10-item questionnaire on a 0-6 point scale with higher values indicating greater impact of COPD.
Measured: Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
St. George's Respiratory Questionnaire (SGRQ)
The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.
Measured: Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.
Measured: Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.
Measured: Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Henan Fantasy Intelligent Technology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963333
- Sponsor's protocol ID
- Daoyin for COPD
- Status last verified
- Mar 2025
- First submitted
- 17 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance: A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06963333
- Acronym / sponsor ID
- Daoyin for COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Stable stage of chronic obstructive pulmonary disease, Tele-home rehabilitation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanxi Bethune Hospital, Henan Fantasy Intelligent Technology Co., Ltd
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 May 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.
This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease in China. Based on the digital management platform, 548 patients with COPD in stable stage were selected as the research objects. A multi-center, randomized, controlled clinical trial design was adopted to scientifically evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability and reveal its mechanism of action. A breath-guided rehabilitation program based on intelligent iot and remote home was established and promoted to improve exercise ability and reduce acute exacerbation. To form high-quality clinical evidence, and realize tracking management, real-time evaluation and effect evaluation throughout rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing guided rehabilitation group | Experimental | Behavioral: Breathing guided exerciseThe breathing guided rehabilitation group will receive conventional western medicine treatment and breathing guided exercise which consists of training and patient education. They will be evaluated with some tests for the study. |
| Flat ground walking training | Active comparator | Behavioral: Flat walking trainingThe flat ground walking training group will receive conventional western medicine treatment and flat walking training which consists of training and patient education. They will be evaluated with some tests for the study. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with COPD in stable stage
- Patients with grade 2 to 4 lung function
- Age 40~80 years old
- Be able to use smart phones, computers and other devices independently or with the help of family members during home training
- Volunteer for treatment and sign an informed consent form
Key exclusion criteria (11 listed)
- Pregnant or lactating women and patients with recent pregnancy plans
- Delirious, dementia, all kinds of mental illness
- Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years
- Patients with severe osteoarthropathy or osteoporosis, unstable fractures
- Patients with severe visual impairment that cannot be improved or who have epilepsy or vertigo and cannot use VR devices
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 |
|---|---|---|
| Breathing guided exerciseBreathing guided exercise are divided into six sections: relaxing standing, two fields breathing, regulating lung and kidney, turning side finger, running kidney hall and nourishing qi and collecting gong. Exercise time: 5 days a week, 1 to 2 times a day, a total of 24 weeks. | Behavioural | Breathing guided rehabilitation group |
| Flat walking trainingFlat walking training can be performed either outdoors or on flat indoor surfaces at a steady pace of 80 to 120 steps per minute for at least 30 minutes each session, raising the heart rate to the target range and maintaining it for over 10 minutes. This should be done 3 to 5 times a week, with 1 to 2 sessions each day, for a total of 24 weeks. The intensity of the exercise is moderate. The target heart rate based on heart rate reserve is calculated as (maximum heart rate during exercise - resting heart rate) × (40-60)% + resting heart rate. | Behavioural | Flat ground walking training |
Primary outcome
6 Minutes Walking Distance Test (6MWD)
Time frame: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The 6-minute walking distance of the two groups was calculated
11 secondary outcomes
Incidence of acute exacerbation
Time frame: Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Degree of breathing difficulty
Time frame: Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Borg dyspnea score
Time frame: Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The COPD Assessment Test(CAT)
Time frame: Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Lung function
Time frame: Changes in baseline Lung function test at weeks 0 and 24 of the treatment.
Anxiety Scale
Time frame: Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Depression Scale
Time frame: Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Clinical symptom assessment questionnaire (CCQ)
Time frame: Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
St. George's Respiratory Questionnaire (SGRQ)
Time frame: Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
Time frame: Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
Time frame: Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
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 9 May 2025.
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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.
Jiansheng Li, doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing guided exercise and Flat walking training in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 11 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: opening soon, as of the sponsor's last update on 9 May 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 China. 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 Hailong Zhang, doctor (+86-0371-66248624, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Distance Test (6MWD) (time frame: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.). 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 9 May 2025.