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

NCT05299385 | Unknown Phase 3 DMC

• 1 other identifier: LFSPMR-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.)

Conditions

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

Keywords

DTx; Digital therapeutics; PR; COPD

Outcome Measures

Primary Outcomes (1)

• The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.

  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.

  12 weeks

Secondary Outcomes (10)

• The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 8 weeks after respiratory rehabilitation compared to the baseline.

  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.

  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.

  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.

  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)

  per week for 12weeks

Study Arms (2)

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

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

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

Device: Digital treatment based on Respiratory Rehabilitation Software

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

Also known as: the conventional rehabilitation treatment

Comparator

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.

Also known as: Respiratory Rehabilitation Software

Experimental treatment

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years-old
• 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%)
• 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)
• Subject who can use effectively smartphone and mobile software
• Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
• Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
• Subject who complies with the clinical protocol

You may not qualify if:

• Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
• Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
• Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
• Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
• a pulmonary arterial hypertension subject
• Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
• Pregnant or lactating women
• Subject who is unable to read text and tough to communicate
• Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
• 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)

Sponsors & Collaborators

• Lifesemantics Corp.: lead
• Asan Medical Center: collaborator
• KangWon National University Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (3)

Kangwon National University Hospital

Chuncheon, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Kangwon National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Diseases; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Sumin Han

CONTACT

+82-1661-2858; sm.han@lifesemantics.kr

Seiwon Lee

CONTACT

iseiwon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 29, 2022
• Study Start: January 13, 2022
• Primary Completion: March 28, 2022
• Study Completion: June 30, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)