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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

NCT ID: NCT03364829

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-06-30

Brief Summary

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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

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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

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group with comparisom before and after intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COPD on Indacaterol/Glycopyrronium

COPD on indacaterol/glycopyrronium for 1 month

Group Type EXPERIMENTAL

Indacaterol/Glycopyrronium

Intervention Type DRUG

Interventions

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Indacaterol/Glycopyrronium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kuan Yuan Chen

Attending Physician of pulmonary medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kang-Yuan Lee

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

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Taipei Medical University-Shuang Ho Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuan-Yuan Chen

Role: CONTACT

Email: [email protected]

Kang-Yuan Lee

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kuan Yuan Chen

Role: primary

Other Identifiers

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TMU-JIRB Form057/20140202

Identifier Type: -

Identifier Source: org_study_id