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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Indacaterol/Glycopyrronium

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kuan-Yuan Chen; Email: a112378633@gmail.com
• Study Contact Backup: Name: Kang-Yuan Lee; Email: 13258@s.tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University-Shuang Ho Hospital
    • Contact: Kuan Yuan Chen; Email: a112378633@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD on Indacaterol/Glycopyrronium; COPD on indacaterol/glycopyrronium for 1 month	Drug: Indacaterol/Glycopyrronium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on daily activity in step counts per 24 hours	Change from baseline daily activity in step counts per 24 hours at 1 month after dual bronchodilator therapy and at 4th month after further combined dual bronchodilator with protocolized pulmonary rehabilitation therapy for 3 months. Daily step counts measured by wearable devices was represented for daily activity	Investigators would measured daily step counts for each patients at baseline, 1 month and 4th month after intervention
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on 6 minutes walking distance in meters	Change from baseline 6 minutes walking distance in meters at 1 month after dual bronchodilator therapy and at 4th month after further combined dual bronchodilator with protocolized pulmonary rehabilitation therapy for 3 months.	Investigators would measured daily steps for each patients at baseline, 1 month and 4th month after intervention
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on heart rate variability	Change from baseline heart rate variability in ratio of low frequency and high frequency at 1 month after dual bronchodilator therapy and at 4th month after further combined dual bronchodilator with protocolized pulmonary rehabilitation therapy for 3 months.	Investigators would measured heart rate variability in ratio of low frequency and high frequency for each patients at baseline, 1 month and 4th month after intervention

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Principal Investigator: Kang-Yuan Lee, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Anticipated): April 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: November 11, 2017
• First Submitted That Met QC Criteria: December 1, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Glycopyrrolate
• Other Study ID Numbers: TMU-JIRB Form057/20140202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No