Multicenter, Prospective, Comparative, Randomized, Single blind, Superior, Pivotal study to evaluate the clinical effectiveness and safety of respiratory rehabilitation software ‘Redpill Breath’ compared to the manual rehabilitation management for those needs respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0006694
- Lead Sponsor
- ifesemantics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Years of age: (Adults) 19 to 80
2. If there is a patient who have 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) patients was 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. a patient 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. a patient who can use effectively smartphone and mobile software
5. a patient who brings their smartphone for a walking test during 12 weeks of the clinical trial.
6. a patient who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
7. a patient who complies with the clinical protocol
1.a person who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
2.a person who participate in respiratory rehabilitation treatment within a year of the screening date
3.a person who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
4.a person who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
5.a pulmonary arterial hypertension patient
6.a person prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
7.Pregnant or lactating women
8.a person who is unable to read text and tough to communicate
9.a person who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
10.a person 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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 6-minute walking distance (6 minute walking distance, 6MWD) change amount (m)2 at 12 weeks after respiratory rehabilitation compared to the base point.
- Secondary Outcome Measures
Name Time Method