The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)

Lifesemantics

Status and phase: Unknown; Phase 3

Conditions: Rehabilitation; Home Based Rehabilitation; Mobile Application; Lung Diseases; Chronic Obstructive Pulmonary Disease; Asthma Copd; Respiratory Rehabilitation; Lung Cancer; Respiratory System Disease; Pulmonary Rehabilitation

Treatments: Device: Digital treatment based on Respiratory Rehabilitation Software; Behavioral: Conventional rehabilition treatment(e.g leaflet) educated by hospital

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05299385

LFSPMR-01

Details and patient eligibility

About

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.)

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Comparator

Active Comparator group

Description:

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

Treatment:

Behavioral: Conventional rehabilition treatment(e.g leaflet) educated by hospital

Experimental treatment

Experimental group

Description:

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

Treatment:

Device: Digital treatment based on Respiratory Rehabilitation Software