NCT05299385

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.)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Lifesemantics Corp. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Conventional rehabilition treatment(e.g leaflet) educated by hospital	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
DEVICE	Digital treatment based on Respiratory Rehabilitation Software	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.

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-03-28
• Completion: 2022-06-30
• First posted: 2022-03-29
• Last updated: 2022-03-29

Locations

3 sites across 1 country: South Korea