NCT03591263

Brief Summary

Chronic obstructive pulmonary disease is a chronic inflammatory lung disease that causes obstructed airflow from the lung, characterized by chronic cough, dyspnea, and sputum production, which often misunderstood as aging or catching a cold. These symptoms may be progressive over time. To provide better disease management and early detecting, pulmonary rehabilitation is now considered a fundamental component of the integrated disease management of this population. However, few studies have evaluated the beneficial outcomes in patients referred to pulmonary rehabilitation. Therefore, the purpose of this study is to investigate the clinical outcomes in patients referred to pulmonary rehabilitation in National Taiwan University Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

6 years

First QC Date

June 12, 2018

Last Update Submit

April 17, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • Functional exercise capacity using the six-minute walk test

    The six-minute walk test is commonly performed to evaluate functional exercise capacity. The six-minute walk test was performed according to the guidelines, and the distance walked in the test presented as functional exercise capacity.

    The six-minute walk test needs six minute to complete the test

  • Muscle strength: hand grip

    Hand grip strength is performed by using hand dynamometer

    Hand grip of both hands need about three minutes to complete

  • Lung hygiene

    Lung hygiene is evaluated by the frequency of acute exacerbation

    Lung hygiene is evaluated as the frequency of acute exacerbation in the the past one year

  • Home-based physical activity

    All subjects were encouraged to increase their daily physical activity and recorded the amount of physical activity on patient-self-record training log.

    Record the home-based physical activities everyday that the subjects have in the past one week that lasting for one year.

  • Muscle strength: leg press

    Maximum leg press is performed by using seated leg press machine

    Maximum leg press measurement needs about four minutes to complete

  • Heart rate

    Heart rate is measured at rest, during hospital-based physical training.

    Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously

  • Blood pressure

    systolic and diastolic pressure are measured at rest, during hospital-based physical training.

    Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously

  • Perceived dyspnea

    Rating of perceived dyspnea is measured by using Borg scale at rest, during hospital-based physical training, and home-based physical activity. The most widely used tool is the "Borg scale", with rating ranges from 0 (nothing at all) to 10 (extremely dyspnea).

    It takes less than one minute to evaluate perceived dyspnea.

  • Oxygen saturation

    Oxygen saturation is continuously monitored by pulse oximetry throughout Hospital-based physical training.

    Hospital-based physical training takes 30 minutes, once a week, and it also takes 30 min to measure continuously

Study Arms (1)

Chronic obstructive pulmonary disease

Subjects with the diagnosis of chronic respiratory disease, such as chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis that referred for evaluation as routine care at Physical Therapy Center (National Taiwan University)

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation as routine care includes, airway clearance techniques, breathing exercise, and physical training instruction

Chronic obstructive pulmonary disease

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic respiratory disease: chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis.

You may qualify if:

  • age \> 20 years old
  • patients with chronic respiratory disease diagnosed by physician that referred to pulmonary rehabilitation in National Taiwan University Hospital including, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, bronchiectasis
  • can cooperate with pulmonary rehabilitation clinic

You may not qualify if:

  • angina, acute myocardial infarction in the previous one month
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Therapy Center at National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li-Ying Wang, Phd

    National Taiwan University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

July 19, 2018

Study Start

June 25, 2018

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations