This study aims to evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability, establish a breath-guided rehabilitation program of intelligent iot and remote home, improve COPD exercise ability, reduce acute exacerbation, and form high-quality clinical evidence.
Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease in China. Based on the digital management platform, 548 patients with COPD in stable stage were selected as the research objects. A multi-center, randomized, controlled clinical trial design was adopted to scientifically evaluate the clinical efficacy of breath-guided improvement of COPD exercise ability and reveal its mechanism of action. A breath-guided rehabilitation program based on intelligent iot and remote home was established and promoted to improve exercise ability and reduce acute exacerbation. To form high-quality clinical evidence, and realize tracking management, real-time evaluation and effect evaluation throughout rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
548
Breathing guided exercise are divided into six sections: relaxing standing, two fields breathing, regulating lung and kidney, turning side finger, running kidney hall and nourishing qi and collecting gong. Exercise time: 5 days a week, 1 to 2 times a day, a total of 24 weeks.
Flat walking training can be performed either outdoors or on flat indoor surfaces at a steady pace of 80 to 120 steps per minute for at least 30 minutes each session, raising the heart rate to the target range and maintaining it for over 10 minutes. This should be done 3 to 5 times a week, with 1 to 2 sessions each day, for a total of 24 weeks. The intensity of the exercise is moderate. The target heart rate based on heart rate reserve is calculated as (maximum heart rate during exercise - resting heart rate) × (40-60)% + resting heart rate.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
6 Minutes Walking Distance Test (6MWD)
The 6-minute walking distance of the two groups was calculated
Time frame: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Incidence of acute exacerbation
The proportion of patients with ≥1 acute exacerbation in each group during the study period was recorded. If the interval between two acute exacerbations was within 5 days, it was considered as 1 acute exacerbation.
Time frame: Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Degree of breathing difficulty
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Time frame: Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Borg dyspnea score
Borg dyspnea score is a 10-point (0-10) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "10" means most severe dyspnea perception.
Time frame: Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The COPD Assessment Test(CAT)
The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.
Time frame: Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lung function
Forced Vital Capacity (FVC)、Forced Expiratory Volume in One Second (FEV1) and Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) were mainly used for lung function evaluation.
Time frame: Changes in baseline Lung function test at weeks 0 and 24 of the treatment.
Anxiety Scale
The Self-Rating Anxiety Scale (SAS) was used to assess the anxiety state of patients. It is a questionnaire consisting of 20 items, with a score range of 1 to 4. The higher the value, the more severe the anxiety state of the patients.
Time frame: Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Depression Scale
The Self-Rating Depression Scale (SDS) was used to assess the depressive state of patients. It is a questionnaire consisting of 20 items, with a score range of 1 to 4. The higher the value, the more severe the depressive state of the patients.
Time frame: Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Clinical symptom assessment questionnaire (CCQ)
The Clinical symptom assessment questionnaire (CCQ) is a self-administered questionnaire that measures healthrelated quality of life. It is an 10-item questionnaire on a 0-6 point scale with higher values indicating greater impact of COPD.
Time frame: Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
St. George's Respiratory Questionnaire (SGRQ)
The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.
Time frame: Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.
Time frame: Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.
Time frame: Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.