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| Name | Class |
|---|---|
| Ministry of Trade, Industry and Energy | UNKNOWN |
| Lifesemantics Corp. | INDUSTRY |
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This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.
Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).
Patients in Group A&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed respiratory rehabilitation program(A) | Experimental | respiratory rehabilitation program for 12 weeks |
|
| Mixed respiratory rehabilitation program(B) | Experimental | Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks |
|
| Control(C) | No Intervention | Ordinary rehabilitation service of the site for 12 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed respiratory rehabilitation | Other | There are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started. |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Modified Medical Research Council dyspnea score | The MMRC dyspnea scale is a five-option grading system. The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath. | 12 weeks |
| change from baseline in COPD Assessment Test(CAT) score | The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact). | 12 weeks |
| change from baseline in real distance walked for 6 minutes | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in Physical activity | Physical activity will be assessed with the daily walking distance monitored by the application and wearable device. | 12 weeks |
| subject satisfaction with health status |
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Inclusion Criteria:
Patients with Lung cancer or COPD
Patients with FEV1<80% or FVC<80% in Pulmonary function test
The distance walked for 6 minutes in 6-minute walk test ≥ 150 m
Patients with android phone
Patients who voluntarily agree to study participation and provide written informed consent form
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea | ||
| Hanyang University Guri Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511633 | Derived | Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2. | |
| 30143475 | Derived | Kwon H, Lee S, Jung EJ, Kim S, Lee JK, Kim DK, Kim TH, Lee SH, Lee MK, Song S, Shin K. An mHealth Management Platform for Patients with Chronic Obstructive Pulmonary Disease (efil breath): Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Aug 24;6(8):e10502. doi: 10.2196/10502. |
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The subjets were randomized(1:1:1) to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group( Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site).
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| Responsive respiratory rehabilitation | Other | The application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise) |
|
changed from baseline in EQ-5D-5L
| 12 weeks |
| subject satisfaction with service | Assessment tool: Patient's Global Assessment - Subjects are scored on four items (general, easy-to-follow, helpful in exercise and Physical fitness ) on a scale of 1-5 depending on their satisfaction level. The sum of scores for each item will be used for assessement of the subject's satisfaction in the trial. | 12 weeks |
| change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients | Comparison with the number of hospitalization during the same period last year | 12 weeks |
| change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients | Comparison with hospitalization period during the same period last year | 12 weeks |
| change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients | Comparison with the number of visiting emergency room during the same period last year | 12 weeks |
| Guri-si |
| Gyeonggi-do |
| 11923 |
| South Korea |
| KyungHee University Medical Center | Seoul | 02447 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Smg-Snu Boramae Medical Center | Seoul | 07061 | South Korea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D008175 | Lung Neoplasms |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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