※ClinicalTrials: Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program. (12/8up)
・First Posted: December 7, 2017
・Last Update Posted: December 7, 2017
・ClinicalTrials.gov Identifier: NCT03364829
・Drug: Indacaterol/Glycopyrronium, Phase 4
・Sponsor: Taipei Medical University Shuang Ho Hospital
Purpose:
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.
・Estimated Enrollment: 50
・Actual Study Start Date: January 1, 2016
・Estimated Study Completion Date: December 31, 2017
・Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Detailed 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.