Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Immune System Diseases

Neoplasms

Rare Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Asthma

Lung Neoplasms

Lung Diseases

Respiration Disorders

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Bronchial Diseases

Hypersensitivity

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

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

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

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

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

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.

Digital treatment based on Respiratory Rehabilitation Software

Sumin Han

Seiwon Lee

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.)

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

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.)

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.

the efficacy variable is the change of respiratory function parameters (6MWT) at V3 compared with the baseline(V2). Statistical significance is tested through the Independent two-sample-test or the Wilcoxon rank sum test. it will be evaluated separately from the primary outcome(6MWD at 12 weeks)

the efficacy variable is the change of respiratory function parameter by modified medical research council Dyspnea scale(mMRC) scores at V3 and V4 compared with the baseline(V2). the total score ranges from 0 to 4, The higher score means more severe symptoms. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

the efficacy variable is the change of respiratory function scores(Structures Respiratory Questionnaire, SGRQ) at V3 and V4 compared with the baseline(V2). Scores range from 0 to 100, with higher scores indicating more limitations. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

the efficacy variable is the change of respiratory function scores(Hospital Anxiety and Depression Scale, HADS) at V3 and V4 compared with the baseline(V2). Scores range from 0 to 21, with the higher score indicating the more depressed and anxious. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

the efficacy variable is the daily step count detection using medical device for 12 weeks. Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

the efficacy variable is number of days of hospitalization for 12 weeks compared with the baseline(V2). Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

the efficacy variable is number of days of hospitalization, number of days of emergency room visits for 12 weeks compared with the baseline(V2). Statistical significance of changes within each group is tested by the Paired -test or Wilcoxon signed rank test.

The analysis of abnormal case analyzes all abnormal cases(TEAE) that occurre after the application of medical devices for clinical trials.

Descriptive statistics(the number of subjects, incidence, and occurrence of coded adverse events) are presented by group. Treatment Emergency Adverse Event (TEAE), Adverse Device Effect (ADE), and Serious Adverse Event (SAE), and the difference in ratio between groups analyzes through Chi-square test or Fisher's exact test. The factors are coded according to SOC and PT using MedDRA. In addition, a detailed list is presented for individual subjects who have experienced significant abnormalities.

the scores of experimental group's Patient Global Assessment (PGA) evaluation using medical device for 12 weeks. PGA is assessed by a single question ranged from 0 to 10. the higher score means the greater patient's satisfaction.

the experimental group's the number of treatments, using medical device for 12 weeks represents descriptive statistics (number of subjects, average, standard deviation, median, minimum, and maximum value)

Spots Global Cancer Trial Database for digital treatment based on respiratory rehabilitation software