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首页> 外文期刊>BMC Neurology >Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in Postpoliomyelitis Syndrome: the protocol of the FACTS-2-PPS trial
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Exercise therapy and cognitive behavioural therapy to improve fatigue, daily activity performance and quality of life in Postpoliomyelitis Syndrome: the protocol of the FACTS-2-PPS trial

机译：运动疗法和认知行为疗法可改善脊髓灰质炎后综合征的疲劳，日常活动表现和生活质量：FACTS-2-PPS试验的方案

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Background Postpoliomyelitis Syndrome (PPS) is a complex of late onset neuromuscular symptoms with new or increased muscle weakness and muscle fatigability as key symptoms. Main clinical complaints are severe fatigue, deterioration in functional abilities and health related quality of life. Rehabilitation management is the mainstay of treatment. Two different therapeutic interventions may be prescribed (1) exercise therapy or (2) cognitive behavioural therapy (CBT). However, the evidence on the effectiveness of both interventions is limited. The primary aim of the FACTS-2-PPS trial is to study the efficacy of exercise therapy and CBT for reducing fatigue and improving activities and quality of life in patients with PPS. Additionally, the working mechanisms, patients' and therapists' expectations of and experiences with both interventions and cost-effectiveness will be evaluated. Methods/Design A multi-centre, single-blinded, randomized controlled trial will be conducted. A sample of 81 severely fatigued patients with PPS will be recruited from 3 different university hospitals and their affiliate rehabilitation centres. Patients will be randomized to one of three groups i.e. (1) exercise therapy + usual care, (2) CBT + usual care, (3) usual care. At baseline, immediately post-intervention and at 3- and 6-months follow-up, fatigue, activities, quality of life and secondary outcomes will be assessed. Costs will be based on a cost questionnaire, and statistical analyses on GEE (generalized estimated equations). Analysis will also consider mechanisms of change during therapy. A responsive evaluation will be conducted to monitor the implementation process and to investigate the perspectives of patients and therapists on both interventions. Discussion A major strength of the FACTS-2-PPS study is the use of a mixed methods design in which a responsive and economic evaluation runs parallel to the trial. The results of this study will generate new evidence for the rehabilitation treatment of persons with PPS. Trial registration Dutch Trial Register NTR1371.
机译：背景脊髓灰质炎后综合症（PPS）是晚期发作的神经肌肉症状的复合体，其中新的或增加的肌肉无力和肌肉易疲劳性为关键症状。主要的临床主诉是严重的疲劳，功能能力下降和健康相关的生活质量。康复管理是治疗的主体。可以规定两种不同的治疗干预措施：（1）运动疗法或（2）认知行为疗法（CBT）。但是，有关两种干预措施有效性的证据有限。 FACTS-2-PPS试验的主要目的是研究运动疗法和CBT减轻PPS患者的疲劳并改善其活动和生活质量的功效。此外，还将评估工作机制，患者和治疗师对干预措施和成本效益的期望和经验。方法/设计将进行多中心，单盲，随机对照试验。将从3家不同的大学医院及其附属康复中心招募81名PPS严重疲劳患者。患者将被随机分为三组之一：（1）运动疗法+常规护理，（2）CBT +常规护理，（3）常规护理。在基线时，立即进行干预后以及在3个月和6个月的随访中，将评估疲劳，活动，生活质量和次要结局。费用将基于费用调查表和GEE（广义估计方程）的统计分析得出。分析还将考虑治疗过程中的变化机制。将进行响应性评估，以监测实施过程并调查患者和治疗师对两种干预措施的看法。讨论FACTS-2-PPS研究的主要优势是使用混合方法设计，在该方法中，响应性和经济性评估与试验平行进行。这项研究的结果将为PPS患者的康复治疗提供新的证据。试用注册荷兰试用注册NTR1371。

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