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

NCT06963333 | Not Yet Recruiting

• 1 other identifier: Daoyin for COPD
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Stable stage of chronic obstructive pulmonary disease; Tele-home rehabilitation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 6 Minutes Walking Distance Test (6MWD)

  The 6-minute walking distance of the two groups was calculated

  Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.

Secondary Outcomes (11)

• Incidence of acute exacerbation

  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

  Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.

• Borg dyspnea score

  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)

  Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.

• Lung function

  Changes in baseline Lung function test at weeks 0 and 24 of the treatment.

Study Arms (2)

Breathing guided rehabilitation group

EXPERIMENTAL

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.

Behavioral: Breathing guided exercise

Flat ground walking training

ACTIVE COMPARATOR

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.

Behavioral: Flat walking training

Interventions

Breathing guided exercise BEHAVIORAL

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.

Breathing guided rehabilitation group

Flat walking training BEHAVIORAL

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.

Flat ground walking training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Shanxi Bethune Hospital: collaborator
• Henan Fantasy Intelligent Technology Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiansheng Li, doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Hailong Zhang, doctor

CONTACT

+86-0371-66248624; zhanghailong6@126.com

Jiansheng Li, doctor

CONTACT

+86-0371-66248624; li_js8@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 9, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 9, 2025

Record last verified: 2025-03

Locations

CN (1)