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OpenTrials
Completed

NCT Number: NCT05906264

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung medical center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-intervention

Behavioral

Tele-intervention every week to check compliance and encourage the rehabilitation

Primary outcomes

  1. Activity minutes in 1 month

    Time frame: 1 month after training

    metabolic equivalents (METs)/day

  2. Pulmonary function test

    Time frame: 1 month after training

    Maximum phonation time (seconds)

  3. Dyspnea scale

    Time frame: 1 month after training

    mMRC dyspnea scale (0-4)

Secondary outcomes

  1. Activity minutes in 3 months

    Time frame: 3 month after training

    metabolic equivalents (METs)/day

  2. Pulmonary function test

    Time frame: 3 month after training

    Pulmonary function test (FEV1/FVC)

  3. Dyspnea scale

    Time frame: 3 month after training

    mMRC dyspnea scale (0-4)

  4. Functional capacity

    Time frame: 3 month after training

    6 minute walk test (m/6min)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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