Idiopathic Pulmonary FibrosisNCT07019714
Daoyin Technique for Improving Exercise Endurance in IPF
A study testing Daoyin Technique and Routine Comprehensive Training in people with Idiopathic Pulmonary Fibrosis, run by Affiliated Hospital of Liaoning University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
This study is based on the previously constructed digital rehabilitation management platform, scientifically evaluating the clinical efficacy of guided technology in improving IPF exercise endurance, and forming high-quality clinical evidence. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Daoyin Technique and Routine Comprehensive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 3 sitesChina
- Study dates
- 22 Apr 2026to 30 Nov 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet the diagnostic criteria for IPF;
- Those who can tolerate guided - technique training;
- Aged between 40 and 85 years old;
- Those who can independently or with the assistance of family members use devices such as smartphones and computers during home - based training;
- Those who voluntarily accept treatment and sign the informed consent form.
Who cannot join
- Patients in the acute exacerbation phase of IPF.
- Patients with comorbidities such as chronic obstructive pulmonary disease, lung cancer, 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, cardiac function at grade 3 or above, stroke, cerebral hemorrhage, etc.).
- Patients with severe liver diseases (such as bleeding caused by liver cirrhosis, portal hypertension, and esophagogastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.).
- Patients with severe osteoarthropathy or osteoporosis, and those with unstable fractures.
- Patients with progressive neuromuscular diseases.
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- Patients with unclear consciousness, dementia, and various mental illnesses.
- Pregnant or lactating women, and patients with a recent pregnancy plan.
- Patients who have been participating in other clinical trials within 1 month before enrollment.
- Patients who need long - term use of ventilators and those with unstable vital signs while bedridden.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100091
bing Wang, MD, +8613426459995, dr_wangbing@126.com
- Recruiting
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicinenese Medicine
Shenyang, Liaoning
Li-Jian Pang, Ph.D, +8615042457760, 1605893852@qq.com
- Recruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
ning-xia Yu, MD, +8613838270138, ynxhucm@163.com
About this study
Official title: Clinical Research on the Improvement of Exercise Endurance in Idiopathic Pulmonary Fibrosis by Daoyin Technique
This study is based on the previously constructed digital rehabilitation management platform, scientifically evaluating the clinical efficacy of guided technology in improving IPF exercise endurance, and forming high-quality clinical evidence.
Read the detailed description
This study is based on a digital and intelligent rehabilitation management platform. It collects patients' movement data through intelligent motion capture equipment and heart rate, blood oxygen, and other data using fitness trackers, to complete rehabilitation tracking management, real-time assessment, and effect evaluation. Adopting a multi-center,non inferiority, randomized controlled clinical trial design, 236 IPF patients were selected as the research subjects. Based on the guideline-directed treatment, the experimental group received guided techniques, while the control group received conventional comprehensive training. The intervention lasted for 3 months, followed by a 3-month follow-up. The primary outcome measures were 6MWD and 30- second sit-to-stand test, while secondary outcome measures included acute exacerbation, FVC, DLCO, VO2 peak, mMRC score, ATAQ-IPF score, etc. The study elucidated the mechanism of action, scientifically evaluated the impact of guided techniques on IPF endurance, and established a guided technique protocol for IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Daoyin Technique, Routine Comprehensive Training
- Keywords
- Idiopathic Pulmonary Fibrosis, Daoyin Technique, randomized controlled trial
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daoyin TechniqueBehavioural
On the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Daoyin Technique for treatment. For patients who are able to complete the respiratory guidance technique. For patients who are unable to complete the respiratory guidance technique but have stable vital signs (referring to the "Expert Consensus on Respiratory Critical Care Rehabilitation Treatment Techniques in China"), the supine guidance technique is selected. It is carried out 5 days a week, 2 times a day, and each training session lasts for 30 minutes.
Routine Comprehensive TrainingBehavioural
On the basis of treatment guided by I"Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline",the experimental group was given Routine Comprehensive Training. According to the patient's condition, select aerobic training (such as walking) or upper - limb and lower - limb resistance training (such as lifting, chest - expanding, foot - pedaling movements, etc.) combined with respiratory training (such as pursed - lip breathing, abdominal breathing, etc.). The heart rate should reach the target heart rate range and last for more than 10 minutes. This training is carried out 5 days a week, 2 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Daoyin Technique in addition to the guideline - directed treatment. | Experimental | The experimental group was given Daoyin Technique in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline " Receives: Behavioral: Daoyin Technique |
| Routine Comprehensive Training in addition to the guideline - directed treatment. | Active comparator | The experimental group was given routine Comprehensive Training in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline " Receives: Behavioral: Routine Comprehensive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Six Minute Walk Distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Change from baseline 6MWD at week 13 and 26.
the 30 - second sit - to - stand test(30s STS)
30s STS will be used to assess pulmonary function.
Measured: Change from baseline FVC at week 13 and 26.
Secondary outcomes (15)
The time of the first acute exacerbation
The time of the patients' first acute exacerbation will be recorded.
Measured: Up to week 26.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Measured: Up to week 26.
Frequency of acute exacerbations resulting in hospitalization
Frequency of acute exacerbation resulting in hospitalization will be recorded.
Measured: Up to week 26.
Frequency of acute exacerbations resulting in ICU admission
Frequency of acute exacerbation resulting in ICU admission will be recorded.
Measured: Up to week 26.
Forced vital capacity (FVC)
FVC will be used to assess pulmonary function.
Measured: Change from baseline FVC at week 13 and 26.
Forced expiratory volume in one second(FEV1)
FEV1 will be used to assess pulmonary function.
Measured: Change from baseline FEV1 at week 13 and 26.
Percent of FEV1#FEV1%#
FEV1% will be used to assess pulmonary function.
Measured: Change from baseline FEV1% at week 13 and 26.
Diffusing Capacity of Carbon Monoxide#DLCO#
DLCO will be used to assess pulmonary function.
Measured: Change from baseline DLCO at week 13 and 26.
Cardiopulmonary Exercise Testing(CPET)
CPET will be used to evaluate the cardiopulmonary function of the human body during exercise. Parameters such as Peak Oxygen Uptake, Anaerobic Threshold, Breathing Reserve, and ventilatory equivalent for carbon dioxide will be collected.
Measured: Change from baseline Peak Oxygen Uptake, Anaerobic Threshold, Breathing Reserve, and ventilatory equivalent for carbon dioxide at week 13 and 26.
Blood oxygen saturation(SpO2)
SpO2 of the subjects is measured by a finger clip pulse oximeter.
Measured: Change from baseline SpO2 at week 13 and 26.
Dyspnea
Dyspnea will be assessed by 22.modified Medical Research Council(mMRC) scores. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse condition.
Measured: Change from baseline mMRC scores at week 13 and 26.
A Tool to Assess Quality of life (ATAQ-IPF)
ATAQ - IPF is currently a specialized scale for evaluating the quality of life of patients, consisting of 13 dimensions and 74 items, with each item being scored from 1 to 5 points. A higher score indicates a worse condition.
Measured: Change from baseline ATAQ-IPF scores at week 13 and 26.
St. George's respiratory questionnaire (SGRQ)
SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. A higher score indicates a worse condition.
Measured: Change from baseline SGRQ scores at week 13 and 26.
Clinical symptoms and Signs
Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition.
Measured: Change from baseline clinical symptoms and signs up at week 13 and 26.
Imaging findings
Imaging findings will bedetected by High - Resolution Computed Tomography (HRCT) of the chest.
Measured: Up to week 13, 26.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start22 Apr 2026
- Primary completion30 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019714
- Sponsor's protocol ID
- Daoyin for IPF
- Status last verified
- Sep 2026
- First submitted
- 5 Jun 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Improvement of Exercise Endurance in Idiopathic Pulmonary Fibrosis by Daoyin Technique
- ClinicalTrials.gov ID
- NCT07019714
- Acronym / sponsor ID
- Daoyin for IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Daoyin Technique, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 13 Jun 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 is based on the previously constructed digital rehabilitation management platform, scientifically evaluating the clinical efficacy of guided technology in improving IPF exercise endurance, and forming high-quality clinical evidence.
Detailed description
This study is based on a digital and intelligent rehabilitation management platform. It collects patients' movement data through intelligent motion capture equipment and heart rate, blood oxygen, and other data using fitness trackers, to complete rehabilitation tracking management, real-time assessment, and effect evaluation. Adopting a multi-center,non inferiority, randomized controlled clinical trial design, 236 IPF patients were selected as the research subjects. Based on the guideline-directed treatment, the experimental group received guided techniques, while the control group received conventional comprehensive training. The intervention lasted for 3 months, followed by a 3-month follow-up. The primary outcome measures were 6MWD and 30- second sit-to-stand test, while secondary outcome measures included acute exacerbation, FVC, DLCO, VO2 peak, mMRC score, ATAQ-IPF score, etc. The study elucidated the mechanism of action, scientifically evaluated the impact of guided techniques on IPF endurance, and established a guided technique protocol for IPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daoyin Technique in addition to the guideline - directed treatment. | Experimental | Behavioral: Daoyin TechniqueThe experimental group was given Daoyin Technique in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline " |
| Routine Comprehensive Training in addition to the guideline - directed treatment. | Active comparator | Behavioral: Routine Comprehensive TrainingThe experimental group was given routine Comprehensive Training in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline " |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who meet the diagnostic criteria for IPF;
- Those who can tolerate guided - technique training;
- Aged between 40 and 85 years old;
- Those who can independently or with the assistance of family members use devices such as smartphones and computers during home - based training;
- Those who voluntarily accept treatment and sign the informed consent form.
Key exclusion criteria (10 listed)
- Patients in the acute exacerbation phase of IPF.
- Patients with comorbidities such as chronic obstructive pulmonary disease, lung cancer, 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, cardiac function at grade 3 or above, stroke, cerebral hemorrhage, etc.).
- Patients with severe liver diseases (such as bleeding caused by liver cirrhosis, portal hypertension, and esophagogastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.).
- Patients with severe osteoarthropathy or osteoporosis, and those with unstable fractures.
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 |
|---|---|---|
| Daoyin TechniqueOn the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Daoyin Technique for treatment. For patients who are able to complete the respiratory guidance technique. For patients who are unable to complete the respiratory guidance technique but have stable vital signs (referring to the "Expert Consensus on Respiratory Critical Care Rehabilitation Treatment Techniques in China"), the supine guidance technique is selected. It is carried out 5 days a week, 2 times a day, and each training session lasts for 30 minutes. | Behavioural | Daoyin Technique in addition to the guideline - directed treatment. |
| Routine Comprehensive TrainingOn the basis of treatment guided by I"Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline",the experimental group was given Routine Comprehensive Training. According to the patient's condition, select aerobic training (such as walking) or upper - limb and lower - limb resistance training (such as lifting, chest - expanding, foot - pedaling movements, etc.) combined with respiratory training (such as pursed - lip breathing, abdominal breathing, etc.). The heart rate should reach the target heart rate range and last for more than 10 minutes. This training is carried out 5 days a week, 2 times a day. | Behavioural | Routine Comprehensive Training in addition to the guideline - directed treatment. |
Primary outcome
6 Six Minute Walk Distance(6MWD)
Time frame: Change from baseline 6MWD at week 13 and 26.
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
the 30 - second sit - to - stand test(30s STS)
Time frame: Change from baseline FVC at week 13 and 26.
30s STS will be used to assess pulmonary function.
15 secondary outcomes
The time of the first acute exacerbation
Time frame: Up to week 26.
Frequency of acute exacerbation
Time frame: Up to week 26.
Frequency of acute exacerbations resulting in hospitalization
Time frame: Up to week 26.
Frequency of acute exacerbations resulting in ICU admission
Time frame: Up to week 26.
Forced vital capacity (FVC)
Time frame: Change from baseline FVC at week 13 and 26.
Forced expiratory volume in one second(FEV1)
Time frame: Change from baseline FEV1 at week 13 and 26.
Percent of FEV1#FEV1%#
Time frame: Change from baseline FEV1% at week 13 and 26.
Diffusing Capacity of Carbon Monoxide#DLCO#
Time frame: Change from baseline DLCO at week 13 and 26.
Cardiopulmonary Exercise Testing(CPET)
Time frame: Change from baseline Peak Oxygen Uptake, Anaerobic Threshold, Breathing Reserve, and ventilatory equivalent for carbon dioxide at week 13 and 26.
Blood oxygen saturation(SpO2)
Time frame: Change from baseline SpO2 at week 13 and 26.
Dyspnea
Time frame: Change from baseline mMRC scores at week 13 and 26.
A Tool to Assess Quality of life (ATAQ-IPF)
Time frame: Change from baseline ATAQ-IPF scores at week 13 and 26.
St. George's respiratory questionnaire (SGRQ)
Time frame: Change from baseline SGRQ scores at week 13 and 26.
Clinical symptoms and Signs
Time frame: Change from baseline clinical symptoms and signs up at week 13 and 26.
Imaging findings
Time frame: Up to week 13, 26.
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 29 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daoyin Technique and Routine Comprehensive Training in people with Idiopathic Pulmonary Fibrosis, run by Affiliated Hospital of Liaoning University of Traditional Chinese Medicine at 3 sites 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 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Li-Jian Pang, Ph.D (+8615042457760, 1605893852@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Six Minute Walk Distance(6MWD) (time frame: Change from baseline 6MWD at week 13 and 26.). 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?
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 29 Sep 2026.