Clinical trial NCT06963333: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Stable stage of chronic obstructive pulmonary disease
Tele-home rehabilitation
randomized controlled trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanxi Bethune Hospital
name: Henan Fantasy Intelligent Technology Co., Ltd
First posted: 2025-05-09
Enrollment: 548
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: 6 Minutes Walking Distance Test (6MWD)
timeFrame: Changes in baseline 6MWD test at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Secondary outcomes:
measure: Incidence of acute exacerbation
timeFrame: Changes in baseline Incidence of acute exacerbation at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: Degree of breathing difficulty
timeFrame: Changes in baseline mMRC scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: Borg dyspnea score
timeFrame: Changes in baseline Borg dyspnea score at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: The COPD Assessment Test(CAT)
timeFrame: Changes in baseline CAT scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: Lung function
timeFrame: Changes in baseline Lung function test at weeks 0 and 24 of the treatment.
measure: Anxiety Scale
timeFrame: Changes in baseline SAS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: Depression Scale
timeFrame: Changes in baseline SDS scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: Clinical symptom assessment questionnaire (CCQ)
timeFrame: Changes in baseline CCQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Changes in baseline SGRQ scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD)
timeFrame: Changes in baseline mESQ-COPD scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
measure: The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)
timeFrame: Changes in baseline mCOPD-PRO scores at weeks 12 and 24 of the treatment period and at 28 weeks of follow-up.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Jiansheng Li, doctor
role: STUDY_CHAIR
References: