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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):
Kuan Yuan Chen, Taipei Medical University Shuang Ho Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Indacaterol/Glycopyrronium Phase 4

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single group with comparisom before and after intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
Drug Information available for: Indacaterol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: COPD on Indacaterol/Glycopyrronium
COPD on indacaterol/glycopyrronium for 1 month
Drug: Indacaterol/Glycopyrronium



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364829


Contacts
Contact: Kuan-Yuan Chen a112378633@gmail.com
Contact: Kang-Yuan Lee 13258@s.tmu.edu.tw

Locations
Taiwan
Taipei Medical University-Shuang Ho Hospital Recruiting
Taipei, Taiwan
Contact: Kuan Yuan Chen       a112378633@gmail.com   
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
Principal Investigator: Kang-Yuan Lee Taipei Medical University Shuang Ho Hospital

Responsible Party: Kuan Yuan Chen, Attending Physician of pulmonary medicine, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03364829     History of Changes
Other Study ID Numbers: TMU-JIRB Form057/20140202
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents