Multicenter Prospective Clinical Trial to Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 10
- 主要终点
- change from baseline in real distance walked for 6 minutes
研究概览
简要总结
This trial is multicenter prospective study to evaluate clinical efficacy of respiratory rehabilitation personalized mobile services for respiratory disease.
详细描述
Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site)).
Patients in Group A&B were provided with mobile application and wearable O2 saturation machine and mobile application monitors physical activity and provides
- how to do stretching, weight training with The-ra Band
- daily and weekly target of exercise
- alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Lung cancer or COPD
- •Patients with FEV1<80% or FVC<80% in Pulmonary function test
- •In case of COPD, post-bronchodilator FEV1 or FVC will be used.
- •Exceptionally Lung Cancer patients with operation, FEV1>80% or FVC>80% will be permitted
- •The distance walked for 6 minutes in 6-minute walk test ≥ 150 m
- •Patients with android phone
- •Patients who voluntarily agree to study participation and provide written informed consent form
排除标准
- •Patients with diseases which could be cause of death or significant disability for 1 year after study enrollment.
- •Patients with diseases that are difficult to walk or improve walking at screening
- •Patients with significant diseases which are difficult to include in this study in accordance with the investigator's judgment
- •Patients who are illiterate or have communication limitations
- •Patients who have a difficulty to complete a questionnaire or are uncooperative due to deterioration of recognition function
研究组 & 干预措施
Fixed respiratory rehabilitation program(A)
respiratory rehabilitation program for 12 weeks
干预措施: Fixed respiratory rehabilitation (Other)
Mixed respiratory rehabilitation program(B)
Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks
干预措施: Fixed respiratory rehabilitation (Other)
Mixed respiratory rehabilitation program(B)
Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks
干预措施: Responsive respiratory rehabilitation (Other)
Control(C)
Ordinary rehabilitation service of the site for 12 weeks
结局指标
主要结局
change from baseline in real distance walked for 6 minutes
时间窗: 12 weeks
change from baseline in Modified Medical Research Council dyspnea score
时间窗: 12 weeks
The MMRC dyspnea scale is a five-option grading system. The scale measures a person's limitation base on a scale of 0-4 and uses the final value to determine how much disability is caused by shortness of breath.
change from baseline in COPD Assessment Test(CAT) score
时间窗: 12 weeks
The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD. Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact. The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact).
次要结局
- change from baseline in Physical activity(12 weeks)
- subject satisfaction with health status(12 weeks)
- subject satisfaction with service(12 weeks)
- change in Healthcare resource utilisation(the number of hospitalization) in COPD(chronic obstructive pulmonary disease) Patients(12 weeks)
- change in Healthcare resource utilisation(hospitalization period) in COPD(chronic obstructive pulmonary disease) Patients(12 weeks)
- change in Healthcare resource utilisation(the number of visiting emergency room) in COPD(chronic obstructive pulmonary disease) Patients(12 weeks)
研究者
Chang-Min Choi
associate professor
Asan Medical Center