The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)
NCT ID: NCT05299385
Last Updated: 2022-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2022-01-13
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Comparator
The investigator provide conventional-treatment to subjects when distributing respiratory rehabilitation education leaflets, Investigators explain the leaflets and self-practice until the subjects fully understand them. Compactor conducts respiratory rehabilitation treatment for 12 weeks according to the following procedures at home
☞ The investigator shall contact the subject every two weeks during the respiratory rehabilitation period and encourage them to perform respiratory rehabilitation treatment according to the assigned group. Subjects perform respiratory rehabilitation exercises at home.
They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol
Conventional rehabilition treatment(e.g leaflet) educated by hospital
Active Comparator: subjects who are trained in accordance with the conventional manual treatment of Respiratory rehabilitation in the clinical institution and taking care home-based management.
The manual contents
* method of the conventional rehabilitation treatment
* intensity for aerobic exercise and anaerobic exercise
Experimental treatment
Subjects install software as a medical device for clinical trials on smart-phones, so that the subject can perform respiratory rehabilitation treatment at home.
Respiratory rehabilitation treatment for 12 weeks
☞ Respiratory rehabilitation treatment using a mobile-based software, consists of aerobic exercise and anaerobic exercise, and the subject performs themselves
They have to visit hospital at 8 weeks (visit 3) and 12 weeks (visit 4) and then examine the factor of the outcome measure following the clinical protocol
Digital treatment based on Respiratory Rehabilitation Software
Experimental: subjects who use the software as a home-based Digital Respiratory Rehabilitation software
It is intended for subjects who are prescribed a respiratory rehabilitation exercise to improve their physical condition. The software also helps them to do self-rehabilitation exercise.
Interventions
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Conventional rehabilition treatment(e.g leaflet) educated by hospital
Active Comparator: subjects who are trained in accordance with the conventional manual treatment of Respiratory rehabilitation in the clinical institution and taking care home-based management.
The manual contents
* method of the conventional rehabilitation treatment
* intensity for aerobic exercise and anaerobic exercise
Digital treatment based on Respiratory Rehabilitation Software
Experimental: subjects who use the software as a home-based Digital Respiratory Rehabilitation software
It is intended for subjects who are prescribed a respiratory rehabilitation exercise to improve their physical condition. The software also helps them to do self-rehabilitation exercise.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject who has difficulty in respiratory symptoms and routine with the criteria as below 1) mMRC(modified Medical Research Council Dyspnea Scale) 1 point at least 2) In accordance with Pulmonary function test(PFT/LET/EEG) examined, if there is in one of the following cases as below \[a lung cancer patient\] (FVC or FEV1 \< 80%), \[No lung cancer patient\] (Post-bronchodilator FEV1/FVC \< 0.7) and (Post-bronchodilator FEV1 \< 80%)
3. Subject with an Android smartphone (OS 8.0 or higher, internal memory (HDD) of 32GB or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD of 32GB or higher)
4. Subject who can use effectively smartphone and mobile software
5. Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
6. Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
7. Subject who complies with the clinical protocol
Exclusion Criteria
2. Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
3. Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
4. Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
5. a pulmonary arterial hypertension subject
6. Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
7. Pregnant or lactating women
8. Subject who is unable to read text and tough to communicate
9. Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
10. Subject who is determined to inappropriate to perform this study according to clinical research associate's opinion(e.g if someone has a bearing on the result of the clinical trial ethically or clinically)
19 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
KangWon National University Hospital
OTHER
SMG-SNU Boramae Medical Center
OTHER
Lifesemantics Corp.
INDUSTRY
Responsible Party
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Locations
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Kangwon National University Hospital
Chuncheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangwon National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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LFSPMR-01
Identifier Type: -
Identifier Source: org_study_id
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