Chronic Disease Community Rehabilitation Service, Northern Sydney Local Health District, North Ryde, NSW, Australia.
Faculty of Medicine and Health, Sydney School of Health Sciences, University of Sydney, Sydney, NSW, Australia.
Phys Ther. 2023 Jul 1;103(7). doi: 10.1093/ptj/pzad044.
The use of digital health is a novel way to improve access to comprehensive pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). This study aims to determine if a home-based pulmonary rehabilitation program supported by mobile health (mHealth) technology is equivalent to center-based pulmonary rehabilitation in terms of improvements in exercise capacity and health status in people with COPD.
This study is a prospective, multicenter, equivalence randomized controlled trial (RCT) with intention-to-treat analysis. A hundred participants with COPD will be recruited from 5 pulmonary rehabilitation programs. Following randomization, participants will be assigned in a concealed manner to receive either home-based pulmonary rehabilitation supported by mHealth or center-based pulmonary rehabilitation. Both programs will be 8 weeks and will include progressive exercise training, disease management education, self-management support, and supervision by a physical therapist. Co-primary outcome measures will be the 6-Minute Walk Test and the COPD Assessment Test. Secondary outcome measures will include the St George's Respiratory Questionnaire, the EuroQol 5 Dimension 5 Level, the modified Medical Research Council dyspnea scale, the 1-minute sit-to-stand test, the 5 times sit-to-stand test, the Hospital Anxiety and Depression Scale, daily physical activity levels, health care utilization, and costs. Outcomes will be measured at baseline and at the end of the intervention. Participant experience will be assessed through semi-structured interviews at the end of the intervention. Utilization of health care and costs will be measured again after 12 months.
This study will be the first rigorous RCT to examine the effects of a home-based pulmonary rehabilitation program supported by mHealth technology that includes comprehensive clinical outcome evaluation, assessment of daily physical activity, a health economic analysis, and qualitative analysis. If findings demonstrate that there is equivalence in clinical outcomes, that the mHealth program costs the least amount (and is thus cost-effective), and that the mHealth program is acceptable to participants, such programs should be widely implemented to improve access to pulmonary rehabilitation.
数字健康是一种提高慢性阻塞性肺疾病（COPD）患者综合肺康复治疗可及性的新方法。本研究旨在确定基于移动健康（mHealth）技术的家庭肺康复计划是否在改善 COPD 患者的运动能力和健康状况方面与基于中心的肺康复等效。
这是一项前瞻性、多中心、等效随机对照试验（RCT），采用意向治疗分析。将从 5 个肺康复计划中招募 100 名 COPD 患者。随机分组后，参与者将以隐蔽的方式被分配接受基于 mHealth 的家庭肺康复或基于中心的肺康复。两个方案均为 8 周，包括渐进性运动训练、疾病管理教育、自我管理支持以及物理治疗师的监督。主要结局指标是 6 分钟步行试验和 COPD 评估测试。次要结局指标包括圣乔治呼吸问卷、欧洲五维健康量表 5 级、改良医学研究委员会呼吸困难量表、1 分钟坐立试验、5 次坐立试验、医院焦虑抑郁量表、日常体力活动水平、卫生保健利用和费用。结果将在基线和干预结束时进行测量。在干预结束时将通过半结构式访谈评估参与者的体验。在 12 个月后再次测量卫生保健的利用和费用。
本研究将是首次严格的 RCT，以检验基于 mHealth 技术的家庭肺康复计划的效果，该计划包括全面的临床结局评估、日常体力活动评估、卫生经济学分析和定性分析。如果研究结果表明临床结局等效、mHealth 方案的成本最低（因此具有成本效益），并且 mHealth 方案被参与者接受，那么此类方案应该广泛实施，以提高肺康复的可及性。
