Rehabilitation of Chronic Diseases and Smart Health Management System Service Provided by Hospital and Community Association
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
研究概览
简要总结
In Republic of Korea, it is not easy to practice standard pulmonary rehabilitation (PR) or cardiac rehabilitation (CR). In this study, the investigators will provide newly developed smartphone application to patients with chronic respiratory, cardiac, or geriatric diseases. The investigators want to confirm whether participants, who perform smartphone application based 12-week PR or CR program, present improved exercise capacity, dyspnea symptom, muscle strength, or quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Dyspnea symptom >= mMRC 1 or NYHA I
- •adults between 20 years and 80 or years
- •Chronic respiratory disease
- •FEV1/FVC < 0.7 in pulmonary function test
- •bronchiectasis in more than one lobe on chest computed tomography
- •FVC of DLCO < 0.8 of predicted value in pulmonary function test
- •Chronic cardiac disease
- •Reperfusion Therapy for angina pectoris or myocardial infarction
- •Heart failure with reduced ejection fraction (LVEF < 50%)
- •Chronic geriatric disease
- •Ages between 60 and 80 years
- •Clinical frailty scale between 1 and 4
排除标准
- •history of acute exacerbation within 4 weeks
- •unable to comply rehabilitation program
- •not suitable for study on decision by duty physician
- •no consent
结局指标
主要结局
change of maximal oxygen consumption (VO2max) at 12 weeks (Chronic respiratory disease group, Chronic cardiac disease group)
时间窗: 12 weeks
The maximum rate of oxygen consumption measured during incremental exercise test (cardiopulmonary exercise test).
change of frailty index at 12 weeks (Chronic geriatric disease group)
时间窗: 12 weeks
The frailty index is defined as the proportion of deficits present in an individual out of the total number of age-related health variables considered. Frailty Index (FI) = (number of health deficits present) ÷ (number of health deficits measured) For example, a person with 20 of 40 deficits collected has an FI score of 20/40 = 0.5 The frailty index ranges 0 (best performance) to 1 (worst performance).
change of 6 minutes walk distance at 12 weeks (Chronic respiratory disease group)
时间窗: 12 weeks
The distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.
次要结局
- change of muscle mass at 12 weeks (all groups)(12 weeks)
- change of diffusing capacity of the lung for carbon monoxide (DLCO) at 12 weeks (Chronic respiratory disease group)(12 weeks)
- change of exercise duration in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)(12 weeks)
- Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score at 12 weeks (all groups)(12 weeks)
- change from dyspnea symptom at 12 weeks (Chronic respiratory disease group, Chronic geriatric disease group)(12 weeks)
- change of muscle strength at 12 weeks (all groups)(12 weeks)
- change of forced expiratory volume in one second (FEV1) at 12 weeks (Chronic respiratory disease group)(12 weeks)
- change of forced vital capacity (FVC) at 12 weeks (Chronic respiratory disease group)(12 weeks)
- change of exercise capacity in cardiopulmonary exercise test at 12 weeks (Chronic cardiac disease group)(12 weeks)
- change from dyspnea symptom at 12 weeks (Chronic cardiac disease group, Chronic geriatric disease group)(12 weeks)
- change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score at 12 weeks (all groups)(12 weeks)
- change of Short physical performance battery (SPPB) at 12 weeks (all groups)(12 weeks)
- Change of chest pain symptom at 12 weeks (Chronic cardiac disease group)(12 weeks)
研究者
Sei Won Lee
professor
Asan Medical Center