NCT07019714

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Nov 2028

First Submitted

Initial submission to the registry

June 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 22, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2.1 years

First QC Date

June 5, 2025

Last Update Submit

September 24, 2026

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary FibrosisDaoyin Techniquerandomized 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.

  • +10 more secondary outcomes

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 TechniqueBEHAVIORAL

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 TrainingBEHAVIORAL

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

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

The Affiliated Hospital of Liaoning University of Traditional Chinese Medicinenese Medicine

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Li-Jian Pang, Ph.D

CONTACT

+86150424577601605893852@qq.com

Xue-qing Yu, Ph.D

CONTACT

13525518843yxqshi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

April 22, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

September 29, 2026

Record last verified: 2026-09

Locations

CN(3)