None listed
Conditions
Interventions
Medical Device, Behavioral : 1. Test group: patients who use the software as the medical device for respiratory Rehabilitation at home.
the medical device for the clinical trial
1) REDFILL SUMTOM/(LS-
Sponsors
Lifesemantics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The 6-minute walking distance (6 minute walking distance, 6MWD) at 8 weeks after respiratory rehabilitation compared to the base point (m) change.;The amount of change in the mMRC (modified medical research council Dyspnea scale) score at 8 and 12 weeks after respiratory rehabilitation compared to the base point (point);The amount of change in the SGRQ (Structures Respiratory Questionnaire) score at 8 and 12 weeks after respiratory rehabilitation compared to the base point (point);The amount of change in the Hospital Anxiety and Depression Scale (HADS) at 8 and 12 weeks after respiratory rehabilitation compared to the base point (point);The amount of change in the average number of daily steps per week during the respiratory rehabilitation treatment period (number of times);The amount of change in the use of medical support (number of hospitalizations, number of days of hospitalization, number of days of emergency room visits) (number of times);Abnormal case (safety evaluation variable);Patient Global Assessment (PGA) evaluation at 12 weeks after respiratory rehabilitation treatment.;Evaluation of the number of treatments during the respiratory rehabilitation treatment period (number of times) | — |
Countries
Korea, Republic of
Contacts
Public ContactSumin Han
Lifesemantics
Outcome results
None listed