Daoyin Technique for Improving Exercise Endurance in IPF

NCT07019714 | Not Yet Recruiting DMC

• 1 other identifier: Daoyin for IPF
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; Daoyin Technique; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 6 Six Minute Walk Distance(6MWD)

  6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.

  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.

  Change from baseline FVC at week 13 and 26.

Secondary Outcomes (15)

• The time of the first acute exacerbation

  Up to week 26.

• Frequency of acute exacerbation

  Up to week 26.

• Frequency of acute exacerbations resulting in hospitalization

  Up to week 26.

• Frequency of acute exacerbations resulting in ICU admission

  Up to week 26.

• Forced vital capacity (FVC)

  Change from baseline FVC at week 13 and 26.

Study Arms (2)

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 "

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 "

Behavioral: Routine Comprehensive Training

Interventions

Daoyin Technique BEHAVIORAL

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.

Daoyin Technique in addition to the guideline - directed treatment.

Routine Comprehensive Training BEHAVIORAL

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.

Routine Comprehensive Training in addition to the guideline - directed treatment.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicinenese Medicine

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Li-Jian Pang, Ph.D

CONTACT

+8615042457760; 1605893852@qq.com

Xue-qing Yu, Ph.D

CONTACT

13525518843; yxqshi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 13, 2025

Record last verified: 2025-05

Locations

CN (1)