NCT06085261尚未招募不适用
Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study
China-Japan Friendship Hospital1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- 6-minute walk distance (6MWD)
研究概览
简要总结
Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a clinical diagnosis of and meeting the following criteria are eligible:
- •Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.
- •Motivated for participating in the project (and acceptance of randomization)
- •Sufficient mobility to attend PR
排除标准
- •Certain comorbidities (e.g. unstable coronary complications)
- •Severe cognitive disabilities (e.g. dementia)
- •Inability to cope with the program because of severe hearing or visual disorder.
结局指标
主要结局
6-minute walk distance (6MWD)
时间窗: 8 weeks; 20 weeks
6-minute walk distance
次要结局
- St. George's Respiratory Questionnaire (SGRQ)(8 weeks; 20 weeks)
- Hospital Anxiety and Depression Scale(HADS)(8 weeks; 20 weeks)
- Short Physical Performance Battery(SPPB)(8 weeks; 20 weeks)
- COPD assessment test(CAT)(8 weeks; 20 weeks)
- modified British medical research council(mMRC)(8 weeks; 20 weeks)
- Respiratory muscle strength(8 weeks; 20 weeks)
- pulmonary function(8 weeks; 20 weeks)
研究者
Ting YANG
Principal Investigator, Clinical Professor
China-Japan Friendship Hospital
研究点 (1)
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