Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program

Taipei Medical University

Status and phase: Unknown; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Indacaterol/Glycopyrronium

Study type: Interventional

Funder types: Other

Identifiers

NCT03364829

TMU-JIRB Form057/20140202

Details and patient eligibility

About

The effectiveness of combined bronchodilator and exercise training on improving exercise capacity has been reported in COPD. However, little is known about effect of respective treatment in a real-time monitoring. Investigators applied wearable devices in monitoring continuously in COPD patients under treatment of combined dual bronchodilator and exercise training and research on associated inflammatory biomarkers profiles change

Full description

The prevalence of chronic obstructive pulmonary disease (COPD) has increased year by year and the estimated mortality rate by 2030 will be in the fourth place. Estimated global prevalence of COPD in the population over age 40 is about 9-10% of the population. In Taiwan, the prevalence is about 16%. COPD is characteristic of irreversible airflow obstruction due to the pathological changes in the small airways, lung parenchyma and pulmonary vessels with chronic inflammation of the specific immune cells, as well as structural changes.

Although studies have suggested that exercise training in patients with COPD benefit the physical activity, but the anti-inflammatory benefits is unknown.Consider individual needs, this study will use the home mobile coach from Dr. Liu domestic development program to further investigate chronic obstructive pulmonary disease patients after receiving this training program,performance and analysis in the clinical laboratory to explore anti-inflammatory and pro-inflammatory between relevance and mechanisms in patients with COPD under real-time wearable devices monitoring

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Global Initiative for Chronic Obstructive Lung Disease (GOLD) according to diagnostic criteria of chronic obstructive pulmonary disease (age ≧ 40 years old and ≦ 85 years old), that the use of post-bronchodilator inhalation, pulmonary function test results of the forced expiratory volume first second (FEV1.0) / forced vital capacity (FVC) <70% 2. COPD patients is not currently accepting any pulmonary rehabilitation program 3. Currently in a stable condition, after researchers explained the purpose of this study, the researchers agreed to participate.

Exclusion criteria

1. Asthma, bronchiectasis, tuberculosis, pneumoconiosis, or other pulmonary diseases
2. Associated with neuromuscular function disorders such as hemiplegia or no independent walking function;
3. Severe heart disease, such as acute myocardial infarction, serious or heart failure, etc.
4. Diagnosed with severe mental disorders such as dementia or poor compliance
5. Acute exacerbation or infection in 3 months

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

COPD on Indacaterol/Glycopyrronium

Experimental group

Description:

COPD on indacaterol/glycopyrronium for 1 month

Treatment:

Drug: Indacaterol/Glycopyrronium