NCT06963333

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 548 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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 - resting heart rate) × (40-60)% + resting heart rate.

Timeline

• Start date: 2025-06-15
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: China