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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Breathing guided exercise; Behavioral: Flat walking training

Study type: Interventional

Funder types: Other

Identifiers

NCT06963333

Daoyin for COPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 548 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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548 participants in 2 patient groups

Breathing guided rehabilitation group

Experimental group

Description:

The breathing guided rehabilitation group will receive conventional western medicine treatment and breathing guided exercise which consists of training and patient education. They will be evaluated with some tests for the study.

Treatment:

Behavioral: Breathing guided exercise

Flat ground walking training

Active Comparator group

Description:

The flat ground walking training group will receive conventional western medicine treatment and flat walking training which consists of training and patient education. They will be evaluated with some tests for the study.

Treatment:

Behavioral: Flat walking training