From the Departments of Rehabilitation (Y.V., E.H.C.C., N.B.M.V., D.M.M., J.T.G., A.C.H.G.) and Neurology (B.G.M.v.E.), Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, Nijmegen; Department of Health Evidence (M.A.J.), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen; and Rehabilitation Center Klimmendaal (N.B.M.V., B.J.v.K., A.H.), Arnhem, the Netherlands.
Neurology. 2019 Oct 29;93(18):e1720-e1731. doi: 10.1212/WNL.0000000000008393. Epub 2019 Sep 30.
To investigate the effectiveness of Energetic, a self-management group program combining aerobic training, energy conservation management, and relapse prevention to improve social participation in patients with neuromuscular disease (NMD) and chronic fatigue.
In this multicenter, assessor-blinded, 2-armed randomized controlled trial with repeated measurements, 53 patients with various types of NMD and chronic fatigue were randomly allocated to Energetic, a 4-month group intervention, or to usual care. The primary endpoint was social participation assessed with the Canadian Occupational Performance Measure (COPM) performance scale immediately postintervention. Secondary outcomes included COPM satisfaction scale, 6-Minute Walk Test (6MWT), and Checklist Individual Strength-subscale fatigue. Participants were followed for 11 months postintervention. Data were analyzed with linear models that account for repeated measurements.
Directly after intervention, the mean group difference for COPM-performance was 1.7 (95% confidence interval [CI] 1.0-2.4; < 0.0001) in favor of the intervention group (n = 29), adjusted for baseline, sex, diagnosis, and work status. This effect was retained at 11 months follow-up (0.9; 95% CI 0.0-1.7; = 0.049). The COPM satisfaction scale and 6MWT improved more in the intervention group compared to usual care. After 3 and 11 months follow-up, most beneficial effects on social participation and functional endurance were retained.
Energetic led to sustainable improvements in social participation and functional endurance compared to usual care in patients with NMD and chronic fatigue.Clinicaltrials.gov IDENTIFIER: NCT02208687.
This study provides Class III evidence that a combination of aerobic training, energy conservation management, and relapse prevention improves social participation in patients with NMD and chronic fatigue.
研究 Energetic，一种将有氧运动训练、能量节约管理和防止复发相结合的自我管理小组方案，以改善神经肌肉疾病（NMD）和慢性疲劳患者的社会参与度。
在这项多中心、评估者设盲、2 臂随机对照试验中，对 53 名患有各种类型的 NMD 和慢性疲劳的患者进行了重复测量，患者被随机分配到 Energetic 组（4 个月的小组干预）或常规护理组。主要终点是干预后立即用加拿大职业表现测量（COPM）绩效量表评估的社会参与度。次要结果包括 COPM 满意度量表、6 分钟步行测试（6MWT）和个人力量检查表疲劳量表。在干预后 11 个月对参与者进行随访。数据分析采用考虑重复测量的线性模型。
干预后直接测量时，COPM 表现的平均组间差异为 1.7（95%置信区间[CI] 1.0-2.4；<0.0001），有利于干预组（n=29），调整了基线、性别、诊断和工作状态。该效果在 11 个月的随访中仍然存在（0.9；95%CI 0.0-1.7；=0.049）。与常规护理相比，干预组的 COPM 满意度量表和 6MWT 改善更多。在 3 个月和 11 个月的随访后，对社会参与和功能耐力的最大有益效果仍然存在。
与常规护理相比，Energetic 可在患有 NMD 和慢性疲劳的患者中，可持续改善社会参与度和功能耐力。
NCT02208687。
这项研究提供了 III 级证据，表明有氧运动训练、能量节约管理和防止复发的组合可改善 NMD 和慢性疲劳患者的社会参与度。
