NCT05299385Unknown3 期
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.)
Lifesemantics Corp.5 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2022年1月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.
研究概览
简要总结
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 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
排除标准
- •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)
结局指标
主要结局
The 6-minute walking distance (6 minute walking distance, 6MWD) change amount(in meters) at 12 weeks after respiratory rehabilitation compared to the baseline.
时间窗: 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.
次要结局
- 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 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 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 number of times in the use of medical support (days of emergency room visits)(12 weeks)
- The number of times in the use of medical support (days of hospitalization)(12 weeks)
- Abnormal case (safety evaluation variable)(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 average number of daily steps per week during the respiratory rehabilitation management period (number of times)(per week for 12weeks)
- Patient Global Assessment (PGA) evaluation for 12 weeks after respiratory rehabilitation management(12 weeks)
- Evaluation of the number of treatments during the respiratory rehabilitation management period (number of times)(12 weeks)
研究者
研究点 (5)
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