--- title: "The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)" nct_id: NCT05299385 overall_status: UNKNOWN phase: PHASE3 sponsor: Lifesemantics Corp. study_type: INTERVENTIONAL primary_condition: Respiratory System Disease countries: South Korea canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05299385.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05299385" ct_last_update_post_date: 2022-03-29 last_seen_at: "2026-05-12T07:34:00.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.) **Official Title:** 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(COPD, Asthma, Lung Cancer, Etc.) **NCT ID:** [NCT05299385](https://clinicaltrials.gov/study/NCT05299385) ## Key Facts - **Status:** UNKNOWN - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 100 - **Lead Sponsor:** Lifesemantics Corp. - **Collaborators:** Asan Medical Center, KangWon National University Hospital, SMG-SNU Boramae Medical Center - **Conditions:** Respiratory System Disease, Chronic Obstructive Pulmonary Disease, Asthma Copd, Lung Cancer, Lung Diseases, Pulmonary Rehabilitation, Respiratory Rehabilitation, Home Based Rehabilitation, Mobile Application, Rehabilitation - **Start Date:** 2022-01-13 - **Completion Date:** 2022-06-30 - **CT.gov Last Update:** 2022-03-29 ## Brief Summary The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.) ## Eligibility - **Minimum age:** 19 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. 19 to 80 years-old 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: 1. Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc. 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) ``` ## Arms - **Comparator** (ACTIVE_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 - **Experimental treatment** (EXPERIMENTAL) — 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 ## Interventions - **Conventional rehabilition treatment(e.g leaflet) educated by hospital** (BEHAVIORAL) — 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** (DEVICE) — 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. ## Primary Outcomes - **The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.** _(time frame: 12 weeks)_ — the primary efficacy variable is the change of respiratory function parameters as a 6-minute walking distance(6MWT) in meters(m) at V4 compared with the baseline(V2). The value of 6MWD at V2 adjust as the value of covariate for statistical significance between the groups. ## Secondary Outcomes - **The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 8 weeks after respiratory rehabilitation compared to the baseline.** _(time frame: 8 weeks)_ - **The amount of change in the modified medical ressearch council Dyspnea scale (mMRC) scores at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.** _(time frame: 8 and 12 weeks)_ - **The amount of change in the Structures Respiratory Questionnaire (SGRQ) score at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.** _(time frame: 8 and 12 weeks)_ - **The amount of change in the Hospital Anxiety and Depression Scale (HADS) at 8 and 12 weeks after respiratory rehabilitation compared to the baseline.** _(time frame: 8 and 12 weeks)_ - **The amount of change in the average number of daily steps per week during the respiratory rehabilitation management period (number of times)** _(time frame: per week for 12weeks)_ - **The number of times in the use of medical support (days of hospitalization)** _(time frame: 12 weeks)_ - **The number of times in the use of medical support (days of emergency room visits)** _(time frame: 12 weeks)_ - **Abnormal case (safety evaluation variable)** _(time frame: 8 and 12 weeks)_ - **Patient Global Assessment (PGA) evaluation for 12 weeks after respiratory rehabilitation management** _(time frame: 12 weeks)_ - **Evaluation of the number of treatments during the respiratory rehabilitation management period (number of times)** _(time frame: 12 weeks)_ ## Locations (3) - Kangwon National University Hospital, Chuncheon, South Korea — _RECRUITING_ - Asan Medical Center, Seoul, South Korea — _RECRUITING_ - Kangwon National University Hospital, Seoul, South Korea — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.kangwon national university hospital|chuncheon||south korea` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `locations.asan medical center|seoul||south korea` — added _(2026-05-12)_ - `locations.kangwon national university hospital|seoul||south korea` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05299385.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05299385* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*