Pulmonary Rehabilitation Program in COPD Patient

March 13, 2025 updated by: Samsung Medical Center

Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient

This study was designed in order to evaluate the compliance of a pulmonary rehabilitation program using a wearable device and the application effect of the program according to the characteristics of each patient, in COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms and airflow limitation. Symptoms of COPD often restricts exercise capacity and activities of daily life of patients. Accordingly, patients with symptomatic COPD have reduced health-related quality of life, which leads to substantial socioeconomic burden.

In order to overcome the limitation associated with COPD pharmacotherapy, the need for a combination of nonpharmacologic therapies, including pulmonary rehabilitation has been suggested constantly. Pulmonary rehabilitation is a method of relieving respiratory distress symptoms through exhalation and inspiratory training, improving exercise ability and contributes in improving lung function and overall quality of life.

Nevertheless, compliance of pulmonary rehabilitation in daily life is low in most COPD patients. Thus, we applied wearable device to detect and evaluate application, compliance and effectiveness pulmonary rehabilitation program in COPD patients, according to the patients' characteristics. Moreover, we sought to use the results of this study as a basic data to establish a strategy for a customized education program for each patient that can be applied to non-face-to-face digital therapeutics in the future.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • COPD patients 18 years of age or older
  • ECOG PS (Eastern Cooperative Oncology Group Performance Status) <2
  • Smart phone user
  • Those who understand the contents of the questionnaire and agree to the research

Exclusion Criteria:

  • Patients with history of lung cancer surgery
  • Patients with bronchiectasis, severe tuberculosis destroyed lung, active pulmonary tuberculosis, non-tuberculous mycobacterial lung disease (NTM), and idiopathic interstitial pneumonia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pulmonary rehabilitation, Control

for COPD patients, who have been trained with the pulmonary rehabilitation program

  • Compliance will be checked by monitoring wearable device at one month
  • Pulmonary function and symptom improvement effect will be checked at 3 months
Active Comparator: Pulmonary rehabilitation, Intervention
Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation
Behavioral: Tele-intervention
Tele-intervention every week to check compliance and encourage the rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity minutes in 1 month
Time Frame: 1 month after training
metabolic equivalents (METs)/day
1 month after training
Pulmonary function test
Time Frame: 1 month after training
Maximum phonation time (seconds)
1 month after training
Dyspnea scale
Time Frame: 1 month after training
mMRC dyspnea scale (0-4)
1 month after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity minutes in 3 months
Time Frame: 3 month after training
metabolic equivalents (METs)/day
3 month after training
Pulmonary function test
Time Frame: 3 month after training
Pulmonary function test (FEV1/FVC)
3 month after training
Dyspnea scale
Time Frame: 3 month after training
mMRC dyspnea scale (0-4)
3 month after training
Functional capacity
Time Frame: 3 month after training
6 minute walk test (m/6min)
3 month after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Actual)

March 14, 2025

Study Completion (Actual)

March 14, 2025

Study Registration Dates

First Submitted

April 19, 2022

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC_COPD_Rehab

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Tele-intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe