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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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Indacaterol/Glycopyrronium
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Medical University-Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COPD on Indacaterol/Glycopyrronium

Arm Description

COPD on indacaterol/glycopyrronium for 1 month

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2017
Last Updated
April 26, 2018
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03364829
Brief Title
Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program
Official Title
Utilizing Wearable Device to Observe the Clinical Response of COPD Patients Treated With Combined Bronchodilator and Home-based Pulmonary Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

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

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
single group with comparisom before and after intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD on Indacaterol/Glycopyrronium
Arm Type
Experimental
Arm Description
COPD on indacaterol/glycopyrronium for 1 month
Intervention Type
Drug
Intervention Name(s)
Indacaterol/Glycopyrronium
Primary Outcome Measure Information:
Title
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on daily activity in step counts per 24 hours
Description
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
Time Frame
Investigators would measured daily step counts for each patients at baseline, 1 month and 4th month after intervention
Title
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on 6 minutes walking distance in meters
Description
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.
Time Frame
Investigators would measured daily steps for each patients at baseline, 1 month and 4th month after intervention
Title
Combined dual bronchodilator and protocolized pulmonary rehabilitation effect on heart rate variability
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuan-Yuan Chen
Email
a112378633@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kang-Yuan Lee
Email
13258@s.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang-Yuan Lee
Organizational Affiliation
Taipei Medical University Shuang Ho Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan Yuan Chen
Email
a112378633@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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