本文由小咖机器人翻译整理

期刊来源：BMJ

原文链接：https://doi.org/10.1136/bmj-2023-076506

摘要内容如下：

客观

评估与常规护理相比，结构化在线监督团体身体和精神健康康复计划是否可以改善患有COVID-19后疾病（LONG COVID）的成人的健康相关生活质量。

设计

实用，多中心，平行组，优势随机对照试验。

设置

英格兰和威尔士，从一个试验中心远程在线提供基于家庭的干预。

参与者

585名成人（26-86岁）在新冠肺炎后至少三个月前从NHS医院出院，并患有持续的身体和/或精神健康后遗症（COVID-19后状况），随机（1:1.03）接受新冠肺炎感染（REGAIN）干预后的康复锻炼和心理支持（n=298）或常规护理（n=287）。

干预措施

最佳实践常规护理是由受过培训的从业人员提供建议和支持的单一在线会议。重获干预是在线提供的，为期八周，包括每周的家庭、现场、监督、集体锻炼和心理支持会议。

主要结果指标

主要结果是在三个月时使用患者报告结果测量信息系统（PROMIS）偏好（PROPR）评分的健康相关生活质量。在3个月、6个月和12个月时测量的次要结果包括PROMIS分项评分（抑郁、疲劳、睡眠障碍、疼痛干扰、身体功能、社会角色/活动和认知功能）、创伤后应激障碍的严重程度、总体健康状况和不良事件。

结果

在2021年1月至2022年7月期间，39697人被邀请参加研究，725人被联系并符合条件。585名参与者被随机分配。平均年龄为56（标准差（SD）12）岁，52%为女性参与者，平均健康相关生活质量PROMIS-PROPR评分为0.20（SD 0.17），平均出院时间为323（SD 144）天。与常规护理相比，在三个月时，REGAIN干预导致健康相关生活质量的改善（PROPR评分的调整平均差异0.03（95%置信区间0.01至0.05），P=0.02），主要是由于PROMIS抑郁（1.39（0.06至2.71），P=0.04）、疲劳（2.50（1.19至3.81），P<0.001）、和疼痛干扰（1.80（0.50至3.11），P=0.01）。效果持续到12个月（0.03（0.01至0.06），p=0.02）。在21例严重不良事件中，仅有1例可能与REGAIN干预有关。在干预组中，141名（47%）参与者完全坚持该方案，117名（39%）部分坚持，40名（13%）未接受干预。

结论

在患有COVID-19后疾病的成人中，与常规护理相比，在线、家庭、监督、团体身体和精神健康康复计划在改善3个月和12个月的健康相关生活质量方面具有临床有效性。

试用注册

ISRCTN注册ISRCTN11466448。

英文原文如下：

Abstracts

OBJECTIVE  To evaluate whether a structured online supervised group physical and mental health rehabilitation programme can improve health related quality of life compared with usual care in adults with post-covid-19 condition (long covid).

DESIGN  Pragmatic, multicentre, parallel group, superiority randomised controlled trial.

SETTING  England and Wales, with home based interventions delivered remotely online from a single trial hub.

PARTICIPANTS  585 adults (26-86 years) discharged from NHS hospitals at least three months previously after covid-19 and with ongoing physical and/or mental health sequelae (post-covid-19 condition), randomised (1:1.03) to receive the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) intervention (n=298) or usual care (n=287).

INTERVENTIONS  Best practice usual care was a single online session of advice and support with a trained practitioner. The REGAIN intervention was delivered online over eight weeks and consisted of weekly home based, live, supervised, group exercise and psychological support sessions.

MAIN OUTCOME MEASURES  The primary outcome was health related quality of life using the patient reported outcomes measurement information system (PROMIS) preference (PROPr) score at three months. Secondary outcomes, measured at three, six, and 12 months, included PROMIS subscores (depression, fatigue, sleep disturbance, pain interference, physical function, social roles/activities, and cognitive function), severity of post-traumatic stress disorder, general health, and adverse events.

RESULTS  Between January 2021 and July 2022, 39 697 people were invited to take part in the study and 725 were contacted and eligible. 585 participants were randomised. Mean age was 56 (standard deviation (SD) 12) years, 52% were female participants, mean health related quality of life PROMIS-PROPr score was 0.20 (SD 0.17), and mean time from hospital discharge was 323 (SD 144) days. Compared with usual care, the REGAIN intervention led to improvements in health related quality of life (adjusted mean difference in PROPr score 0.03 (95% confidence interval 0.01 to 0.05), P=0.02) at three months, driven predominantly by greater improvements in the PROMIS subscores for depression (1.39 (0.06 to 2.71), P=0.04), fatigue (2.50 (1.19 to 3.81), P<0.001), and pain interference (1.80 (0.50 to 3.11), P=0.01). Effects were sustained at 12 months (0.03 (0.01 to 0.06), P=0.02). Of 21 serious adverse events, only one was possibly related to the REGAIN intervention. In the intervention group, 141 (47%) participants fully adhered to the programme, 117 (39%) partially adhered, and 40 (13%) did not receive the intervention.

CONCLUSIONS  In adults with post-covid-19 condition, an online, home based, supervised, group physical and mental health rehabilitation programme was clinically effective at improving health related quality of life at three and 12 months compared with usual care.

TRIAL REGISTRATION  ISRCTN registry ISRCTN11466448.

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