Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance

Official title

Clinical Study on Improving Exercise Capacity in Chronic Obstructive Pulmonary Disease Through Smart IoT-Remote Home Breathing Guidance: A Multicenter, Randomized, Controlled Clinical Trial

Overview

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.

Detailed description

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.

Interventions

• Behavioral Breathing guided exercise
  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.
• Behavioral Flat walking training
  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 - resti

Primary outcome measures

• 6 Minutes Walking Distance Test (6MWD) [Time frame: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.]

Secondary outcome measures (11)

• Incidence of 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 [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 [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) [Time frame: Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.]
• Lung function [Time frame: Changes in baseline Lung function test at weeks 0 and 24 of the treatment.]
• Anxiety Scale [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 [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) [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) [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) [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) [Time frame: Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.]

Eligibility criteria

Inclusion criteria

• Patients with COPD in stable stage
• Patients with grade 2 to 4 lung function
• Age 40\~80 years old
• Be able to use smart phones, computers and other devices independently or with the help of family members during home training
• Volunteer for treatment and sign an informed consent form

Exclusion criteria

• Pregnant or lactating women and patients with recent pregnancy plans
• Delirious, dementia, all kinds of mental illness
• Tumor patients who have undergone resection, radiation, and chemotherapy within 5 years
• Patients with severe osteoarthropathy or osteoporosis, unstable fractures
• Patients with severe visual impairment that cannot be improved or who have epilepsy or vertigo and cannot use VR devices
• Patients with progressive neuromuscular disease
• Patients with pulmonary abscess, pulmonary interstitial fibrosis, 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, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.)
• Patients with severe liver disease (cirrhosis, portal hypertension and bleeding caused by esophageal and gastric varices, etc.) and severe kidney disease (dialysis, kidney transplantation, etc.)
• Participants who were participating in other clinical trials within 1 month prior to enrollment
• People who stay in bed for a long time for various reasons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou

Identifiers

NCT: NCT06963333 · Daoyin for COPD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗