Daoyin Technique for Improving Exercise Endurance in IPF

Официальное название

Clinical Research on the Improvement of Exercise Endurance in Idiopathic Pulmonary Fibrosis by Daoyin Technique

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Daoyin Technique
  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 Rehabili
• Поведенческое Routine Comprehensive Training
  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 purs

Первичные конечные точки

• 6 Six Minute Walk Distance(6MWD) [Срок оценки: Change from baseline 6MWD at week 13 and 26.]
• the 30 - second sit - to - stand test(30s STS) [Срок оценки: Change from baseline FVC at week 13 and 26.]

Вторичные конечные точки (12)

• The time of the first acute exacerbation [Срок оценки: Up to week 26.]
• Frequency of acute exacerbation [Срок оценки: Up to week 26.]
• Frequency of acute exacerbations resulting in hospitalization [Срок оценки: Up to week 26.]
• Frequency of acute exacerbations resulting in ICU admission [Срок оценки: Up to week 26.]
• Forced vital capacity (FVC) [Срок оценки: Change from baseline FVC at week 13 and 26.]
• Forced expiratory volume in one second(FEV1) [Срок оценки: Change from baseline FEV1 at week 13 and 26.]
• Percent of FEV1#FEV1%# [Срок оценки: Change from baseline FEV1% at week 13 and 26.]
• Diffusing Capacity of Carbon Monoxide#DLCO# [Срок оценки: Change from baseline DLCO at week 13 and 26.]
• Cardiopulmonary Exercise Testing(CPET) [Срок оценки: 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) [Срок оценки: Change from baseline SpO2 at week 13 and 26.]
• Dyspnea [Срок оценки: Change from baseline mMRC scores at week 13 and 26.]
• A Tool to Assess Quality of life (ATAQ-IPF) [Срок оценки: Change from baseline ATAQ-IPF scores at week 13 and 26.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Hospital of Liaoning University of Traditional Chinese Medicinenese Medicin — Шэньян

Идентификаторы

NCT: NCT07019714 · Daoyin for IPF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗