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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
236
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.
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.
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicinenese Medicine
Shenyang, Liaoning, China
6 Six Minute Walk Distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Time frame: 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.
Time frame: Change from baseline FVC at week 13 and 26.
The time of the first acute exacerbation
The time of the patients' first acute exacerbation will be recorded.
Time frame: Up to week 26.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Time frame: Up to week 26.
Frequency of acute exacerbations resulting in hospitalization
Frequency of acute exacerbation resulting in hospitalization will be recorded.
Time frame: Up to week 26.
Frequency of acute exacerbations resulting in ICU admission
Frequency of acute exacerbation resulting in ICU admission will be recorded.
Time frame: Up to week 26.
Forced vital capacity (FVC)
FVC will be used to assess pulmonary function.
Time frame: Change from baseline FVC at week 13 and 26.
Forced expiratory volume in one second(FEV1)
FEV1 will be used to assess pulmonary function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Change from baseline FEV1 at week 13 and 26.
Percent of FEV1#FEV1%#
FEV1% will be used to assess pulmonary function.
Time frame: Change from baseline FEV1% at week 13 and 26.
Diffusing Capacity of Carbon Monoxide#DLCO#
DLCO will be used to assess pulmonary function.
Time frame: 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.
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)
SpO2 of the subjects is measured by a finger clip pulse oximeter.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to week 13, 26.