Institute of Clinical Science.
Birmingham Clinical Trials Unit, Institute of Applied Health Research.
Rheumatology (Oxford). 2021 Sep 1;60(9):4130-4140. doi: 10.1093/rheumatology/keaa890.
Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients.
AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥14) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention.
A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable.
This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial.
ISRCTN11929227.
尽管血管炎（AAV）患者的疾病已得到缓解，但仍会经历高水平的疲劳。本研究评估了一项基于行为的体力活动干预措施对支持 AAV 患者疲劳自我管理的确定性随机对照试验的可行性和可接受性。
在这项单中心开放性随机对照可行性研究中，招募了疾病缓解期且伴有疲劳（多维疲劳清单-20 一般疲劳域≥14）的 AAV 患者，将其随机分配到干预组或标准护理组。干预持续 12 周，包括与促进者进行 8 次面对面的体力活动课程和 12 次每周电话。参与者被鼓励使用跟踪器设备（Fitbit）监测他们的体力活动。标准护理包括向疲劳网站提供指导。主要结局是根据三项“停止/继续”红绿灯标准评估的 III 期试验的可行性，包括招募、干预依从性和研究退出。一项定性研究评估了参与者对干预的看法。
共有 248 名患者接受了筛查，其中 134 名符合条件（54%）。招募符合黄灯标准；43/134（32%，95%CI：24，40）符合条件的参与者被随机分组，依从性符合黄灯标准；73%的参与者参加了所有 8 次体力活动课程，但只有 11/22（50%，95%CI：29，71%）按照预定计划完成了干预，研究退出符合绿灯标准；2/43 名参与者在 24 周前退出（5%，95%CI：0，11）。定性研究结果表明该干预措施是可以接受的。
本研究表明，针对疲劳自我管理的基于行为的体力活动干预措施对 AAV 患者是可以接受的，尽管在进行确定性试验之前，需要对招募和方案依从性进行修改。
ISRCTN86233055。
