针对肺高血压患者的运动康复多中心随机对照试验的协议更新:SPHERe试验
Stuart Ennis1,2, Julie Bruce1,2, Harbinder Sandhu1
1Warwick Medical School, University of Warwick, Coventry, UK.
监督肺高血压炼康复 (SPHERe) 试验因COVID-19而调整了其协议,转向在线交付. 这标志着在线康复肺高血压的第一次随机对照试验.
科学领域:
- 心脏病学 心脏病学
- 肺部医学 肺部医学
- 康复医学 康复医学 康复医学
背景情况:
- 该SPHERe试验最初旨在评估肺高血压 (PH) 的监督运动康复.
- 由于COVID-19的流行,人们不得不停止对这个弱势群体进行面对面的干预.
- 试验程序需要大量调整,以保持参与者的安全和试验的连续性.
研究的目的:
- 描述因应COVID-19限制而修改的SPHERe试验协议.
- 评估一个适应的,远程传递PH的康复计划的临床和成本效益.
- 为PH患者建立一个在线团体康复模式.
主要方法:
- 该SPHERe试验从以中心为基础的中心转向远程交付的在线小组会议.
- 在与利益相关者和患者进行商后,符合条件的变化最小.
- 修改后的协议得到了资助者和独立试验委员会的批准.
主要成果:
- 在疫情期间,SPHERe试验成功过渡到在线交付模式.
- 这种调整允许继续研究PH康复.
- 修改后的协议有助于在线PH康复的第一个随机对照试验.
结论:
- 由于COVID-19,SPHERe试验协议已成功修改为远程分娩.
- 这代表了第一个随机对照试验,评估了肺高血压在线群体康复计划.
- 经过调整的SPHERe试验为在公共卫生危机期间为PH患者提供康复提供了一个模型.
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