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

NCT03364829 | Unknown Phase 4

• 1 other identifier: TMU-JIRB Form057/20140202
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

COPD on Indacaterol/Glycopyrronium

EXPERIMENTAL

COPD on indacaterol/glycopyrronium for 1 month

Drug: Indacaterol/Glycopyrronium

Interventions

Indacaterol/Glycopyrronium DRUG

COPD on Indacaterol/Glycopyrronium

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Glycopyrrolate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kang-Yuan Lee

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuan-Yuan Chen

CONTACT

a112378633@gmail.com

Kang-Yuan Lee

CONTACT

13258@s.tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of pulmonary medicine

Model Details: single group with comparisom before and after intervention

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: December 7, 2017
• Study Start: January 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: June 30, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)