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

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ClinicalTrials.gov Identifier: NCT03364829
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):

November 11, 2017
December 7, 2017
December 7, 2017
January 1, 2016
December 31, 2017   (Final data collection date for primary outcome measure)
  • Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on daily activity in step counts per 24 hours [ Time Frame: Investigators would measured daily step counts for each patients at baseline, 1 month and 4th month after intervention ]
    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
  • Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on 6 minutes walking distance in meters [ Time Frame: Investigators would measured daily steps for each patients at baseline, 1 month and 4th month after intervention ]
    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.
  • Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on heart rate variability [ Time Frame: 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 ]
    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.
Same as current
No Changes Posted
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Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program
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

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

Interventional
Phase 4
Intervention Model: Single Group Assignment
Intervention Model Description:
single group with comparisom before and after intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Drug: Indacaterol/Glycopyrronium
Experimental: COPD on Indacaterol/Glycopyrronium
COPD on indacaterol/glycopyrronium for 1 month
Intervention: Drug: Indacaterol/Glycopyrronium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
Yes
Contact: Kuan-Yuan Chen a112378633@gmail.com
Contact: Kang-Yuan Lee 13258@s.tmu.edu.tw
Taiwan
 
 
NCT03364829
TMU-JIRB Form057/20140202
Not Provided
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
Plan to Share IPD: No
Kuan Yuan Chen, Taipei Medical University Shuang Ho Hospital
Taipei Medical University Shuang Ho Hospital
Not Provided
Principal Investigator: Kang-Yuan Lee Taipei Medical University Shuang Ho Hospital
Taipei Medical University Shuang Ho Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP