Efficacy of Smartphone Application Based Rehabilitations in Patients With Chronic Respiratory or Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular 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 or cardiovascular 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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 II
- •adults between 20 years and 80 or years
- •Chronic respiratory disease
- •FEV1/FVC < 0.7 or FEV1< 0.8 of predicted value in pulmonary function test
- •bronchiectasis in more than one lobe on chest computed tomography
- •FVC or DLCO < 0.8 of predicted value in pulmonary function test
- •Chronic cardiovascular disease
- •Reperfusion Therapy for angina pectoris or myocardial infarction
- •Heart failure with reduced ejection fraction (LVEF < 50%)
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 Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic cardiovascular disease group)
时间窗: 12 weeks
A questionnaire assessing health related quality of life on 4 health dimensions (physical, mental, social, positive health dimension). Each item is scored 1-4, yielding a total between 8 and 40. The scores range from 8 (best performance) to 40 (worst performance).
Change of Chronic obstructive pulmonary disease (COPD) assessment Test (CAT) (Chronic respiratory disease group)
时间窗: 12 weeks
Self reported Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status. Each item is scored 0-5, yielding a total between 0 and 40
change of maximal oxygen consumption (VO2max)
时间窗: 12 weeks
The maximal oxygen consumption (VO2max) is measured during incremental exercise test (cardiopulmonary exercise test).
次要结局
- change of dyspnea symptom (Chronic cardiovascular disease group)(12 weeks)
- change of limb muscle mass(12 weeks)
- change of dyspnea symptom (Chronic respiratory disease group)(12 weeks)
- Change of EuroQol 5-dimension 5-level (EQ-5D-5L) score(12 weeks)
- change of Korean Health-related Quality of Life Instrument with 8 Items (HINT-8) score (Chronic respiratory disease group)(12 weeks)
- change of forced expiratory volume in one second (FEV1) (Chronic respiratory disease group)(12 weeks)
- change of diffusing capacity of the lung for carbon monoxide (DLCO) (Chronic respiratory disease group)(12 weeks)
- change of exercise capacity in cardiopulmonary exercise test (Chronic cardiovascular disease group)(12 weeks)
- change of hand grip strength(12 weeks)
- change of forced vital capacity (FVC) (Chronic respiratory disease group)(12 weeks)
- change of exercise duration in cardiopulmonary exercise test (Chronic cardiovascular disease group)(12 weeks)
- Change of chest pain symptom (Chronic cardiovascular disease group)(12 weeks)
研究者
Sei Won Lee
professor
Asan Medical Center