Daoyin Technique for Improving Exercise Endurance in IPF

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Behavioral: Daoyin Technique; Behavioral: Routine Comprehensive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07019714

Daoyin for IPF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who meet the diagnostic criteria for IPF;
2. Those who can tolerate guided - technique training;
3. Aged between 40 and 85 years old;
4. Those who can independently or with the assistance of family members use devices such as smartphones and computers during home - based training;
5. Those who voluntarily accept treatment and sign the informed consent form.

Exclusion criteria

1. Patients in the acute exacerbation phase of IPF.
2. Patients with comorbidities such as chronic obstructive pulmonary disease, lung cancer, active pulmonary tuberculosis, bronchiectasis, pulmonary embolism, and other pulmonary diseases.
3. 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.).
4. 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.).
5. Patients with severe osteoarthropathy or osteoporosis, and those with unstable fractures.
6. Patients with progressive neuromuscular diseases.
7. Patients with unclear consciousness, dementia, and various mental illnesses.
8. Pregnant or lactating women, and patients with a recent pregnancy plan.
9. Patients who have been participating in other clinical trials within 1 month before enrollment.
10. Patients who need long - term use of ventilators and those with unstable vital signs while bedridden.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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236 participants in 2 patient groups

Daoyin Technique in addition to the guideline - directed treatment.

Experimental group

Description:

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 "

Treatment:

Behavioral: Daoyin Technique

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

Active Comparator group

Description:

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 "

Treatment:

Behavioral: Routine Comprehensive Training