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Pulmonary Rehabilitation Program in COPD Patient

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tele-intervention
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary Rehabilitation, Tele-rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Pulmonary rehabilitation, Control

Pulmonary rehabilitation, Intervention

Arm Description

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

Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation

Outcomes

Primary Outcome Measures

Activity minutes in 1 month
metabolic equivalents (METs)/day
Pulmonary function test
Maximum phonation time (seconds)
Dyspnea scale
mMRC dyspnea scale (0-4)

Secondary Outcome Measures

Activity minutes in 3 months
metabolic equivalents (METs)/day
Pulmonary function test
Pulmonary function test (FEV1/FVC)
Dyspnea scale
mMRC dyspnea scale (0-4)
Functional capacity
6 minute walk test (m/6min)

Full Information

First Posted
April 19, 2022
Last Updated
June 7, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05906264
Brief Title
Pulmonary Rehabilitation Program in COPD Patient
Official Title
Evaluation of Compliance and Effectiveness of Pulmonary Rehabilitation Program in COPD Patient
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
August 19, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary Rehabilitation, Tele-rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Compared to control group, interventional group will be provided tele-intervention every week, checking compliance and encouraging the rehabilitation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary rehabilitation, Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Pulmonary rehabilitation, Intervention
Arm Type
Active Comparator
Arm Description
Compared to Control group, Intervention group will be provided with additional tele-intervention every week to check the compliance and encourage of the rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Tele-intervention
Intervention Description
Tele-intervention every week to check compliance and encourage the rehabilitation
Primary Outcome Measure Information:
Title
Activity minutes in 1 month
Description
metabolic equivalents (METs)/day
Time Frame
1 month after training
Title
Pulmonary function test
Description
Maximum phonation time (seconds)
Time Frame
1 month after training
Title
Dyspnea scale
Description
mMRC dyspnea scale (0-4)
Time Frame
1 month after training
Secondary Outcome Measure Information:
Title
Activity minutes in 3 months
Description
metabolic equivalents (METs)/day
Time Frame
3 month after training
Title
Pulmonary function test
Description
Pulmonary function test (FEV1/FVC)
Time Frame
3 month after training
Title
Dyspnea scale
Description
mMRC dyspnea scale (0-4)
Time Frame
3 month after training
Title
Functional capacity
Description
6 minute walk test (m/6min)
Time Frame
3 month after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung medical center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye Yun Park, MD
Phone
82)1099335821
Email
kerrybe.park@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30286833
Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
28848899
Citation
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Citation
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Citation
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Citation
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Citation
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Pulmonary Rehabilitation Program in COPD Patient

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