Bachmair Eva-Maria, Martin Kathryn, Aucott Lorna, Dhaun Neeraj, Dures Emma, Emsley Richard, Gray Stuart R, Kidd Elizabeth, Kumar Vinod, Lovell Karina, MacLennan Graeme, McNamee Paul, Norrie John, Paul Lorna, Packham Jon, Ralston Stuart H, Siebert Stefan, Wearden Alison, Macfarlane Gary, Basu Neil
Aberdeen Centre for Arthritis and Musculoskeletal Health, University of Aberdeen, Aberdeen, UK.
Centre of Healthcare and Randomised Trials (CHaRT), Health Service Research Unit, University of Aberdeen, Aberdeen, UK.
Lancet Rheumatol. 2022 Jun 27;4(8):e534-e545. doi: 10.1016/S2665-9913(22)00156-4. eCollection 2022 Aug.
Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases. Cognitive behavioural approaches (CBA) and personalised exercise programmes (PEP) can be effective, but they are not often implemented because their effectivenesses across the different inflammatory rheumatic diseases are unknown and regular face-to-face sessions are often undesirable, especially during a pandemic. We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases.
LIFT is a multicentre, randomised, controlled, open-label, parallel-group trial to assess usual care alongside telephone-delivered CBA or PEP against usual care alone in UK hospitals. Patients with any stable inflammatory rheumatic disease were eligible if they reported clinically significant, persistent fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Coprimary outcomes were fatigue severity (Chalder Fatigue Scale) and impact (Fatigue Severity Scale) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov (NCT03248518).
From Sept 4, 2017, to Sept 30, 2019, we randomly assigned and treated 367 participants to PEP (n=124; one participant withdrew after being randomly assinged), CBA (n=121), or usual care alone (n=122), of whom 274 (75%) were women and 92 (25%) were men with an overall mean age of 57·5 (SD 12·7) years. Analyses for Chalder Fatigue Scale included 101 participants in the PEP group, 107 in the CBA group, and 107 in the usual care group and for Fatigue Severity Scale included 101 in PEP, 106 in CBA, and 107 in usual care groups. PEP and CBA significantly improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference -3·03 [97·5% CI -5·05 to -1·02], p=0·0007; CBA: -2·36 [-4·28 to -0·44], p=0·0058) and fatigue impact (Fatigue Severity Scale; PEP: -0·64 [-0·95 to -0·33], p<0·0001; CBA: -0·58 [-0·87 to -0·28], p<0·0001); compared with usual care alone at 56 weeks. No trial-related serious adverse events were reported.
Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of inflammatory rheumatic diseases. These interventions should be considered as a key component of inflammatory rheumatic disease management in routine clinical practice.
Versus Arthritis.
慢性疲劳在炎性风湿性疾病患者中是一个管理不善的问题。认知行为疗法（CBA）和个性化运动计划（PEP）可能有效，但由于它们在不同炎性风湿性疾病中的有效性未知，且定期面对面治疗往往不可行，尤其是在大流行期间，因此它们并不常被采用。我们假设通过远程提供CBA和PEP可以有效减轻炎性风湿性疾病患者的疲劳严重程度和对生活的影响。
LIFT是一项多中心、随机、对照、开放标签、平行组试验，旨在评估英国医院中电话提供的CBA或PEP联合常规护理与单纯常规护理的效果。患有任何稳定炎性风湿性疾病且报告有临床上显著的持续性疲劳的患者符合入选条件。治疗分配由基于网络的随机系统进行。CBA和PEP疗程由经过培训的风湿病学专业健康人员在6个月内完成。共同主要结局是56周时的疲劳严重程度（Chalder疲劳量表）和影响（疲劳严重程度量表）。主要分析采用全分析集。本研究已在ClinicalTrials.gov注册（NCT03248518）。
从2017年9月4日至2019年9月30日，我们随机分配并治疗了367名参与者，其中124名接受PEP（一名参与者在随机分配后退出），121名接受CBA，122名接受单纯常规护理，其中274名（75%）为女性，92名（25%）为男性，总体平均年龄为57.5（标准差12.7）岁。Chalder疲劳量表分析中，PEP组有101名参与者，CBA组有107名，常规护理组有107名；疲劳严重程度量表分析中，PEP组有101名，CBA组有106名，常规护理组有107名。PEP和CBA均显著改善了疲劳严重程度（Chalder疲劳量表；PEP：调整后平均差值 -3.03 [97.5%可信区间 -5.05至 -1.02]，p = 0.0007；CBA： -2.36 [-4.28至 -0.44]，p = 0.0058）和疲劳影响（疲劳严重程度量表；PEP： -0.64 [-0.95至 -0.33]，p < 0.0001；CBA： -0.58 [-0.87至 -0.28]，p < 0.0001）；与56周时的单纯常规护理相比。未报告与试验相关的严重不良事件。
通过电话提供的CBA和PEP在多种炎性风湿性疾病中使疲劳的严重程度和影响在统计学和临床上均显著降低并得以维持。这些干预措施应被视为常规临床实践中炎性风湿性疾病管理的关键组成部分。
对抗关节炎组织。
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