Pulmonary Rehabilitation Program in COPD Patient

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05906264
Collaborator
(none)
64
1
2
15.7
4.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tele-intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient
Actual Study Start Date :
Jun 9, 2022
Anticipated Primary Completion Date :
Aug 19, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Activity minutes in 1 month [1 month after training]

    metabolic equivalents (METs)/day

  2. Pulmonary function test [1 month after training]

    Maximum phonation time (seconds)

  3. Dyspnea scale [1 month after training]

    mMRC dyspnea scale (0-4)

Secondary Outcome Measures

  1. Activity minutes in 3 months [3 month after training]

    metabolic equivalents (METs)/day

  2. Pulmonary function test [3 month after training]

    Pulmonary function test (FEV1/FVC)

  3. Dyspnea scale [3 month after training]

    mMRC dyspnea scale (0-4)

  4. Functional capacity [3 month after training]

    6 minute walk test (m/6min)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung medical center Seoul Korea, Republic of

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05906264
Other Study ID Numbers:
  • SMC_COPD_Rehab
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samsung Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023