一项针对多发性硬化症患者的运动加行为改变干预的随机对照试验：“加速行动”研究方案
A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol.
作者信息
Coote Susan, Gallagher Stephen, Msetfi Rachel, Larkin Aidan, Newell John, Motl Robert W, Hayes Sara
机构信息
Department of Clinical Therapies, University of Limerick, Limerick, Ireland.
Department of Psychology, Centre for Social Issues Research, University of Limerick, Limerick, Ireland.
出版信息
BMC Neurol. 2014 Dec 21;14:241. doi: 10.1186/s12883-014-0241-9.
BACKGROUND
Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.
METHODS/DESIGN: People with a diagnosis of MS who walk independently, score of 0-3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention.
DISCUSSION
This randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02301442.
背景
运动一直以来都对多发性硬化症（MS）患者的健康状况产生短期积极影响。然而，这些影响在长期内并未得到维持。行为改变干预旨在促进长期积极的生活方式改变。本研究，即“加速行动”，将比较运动加基于社会认知理论（SCT）的行为改变干预与运动加对照教育干预对MS患者步行能力的影响。
方法/设计：被诊断为MS且能独立行走、患者疾病进展评分在0至3分之间、在过去12周内未经历MS复发或MS药物变化且身体不活跃的患者将被随机分配到两种研究条件之一。实验组将接受为期10周的运动加基于SCT的行为改变干预。对照组将接受为期10周的运动加教育干预以控制接触。参与者将在第1、12、24和36周接受评估。主要结局将是步行能力。次要结局将包括：有氧能力、下肢肌肉力量、参与者对运动计划的依从性、自我报告的运动强度、自我报告的运动乐趣、运动自我效能、运动的结果期望、运动目标设定、对运动益处和障碍的认知、社会支持感知、MS的身体和心理影响以及疲劳。干预后将在参与者中完成对“加速行动”的定性评估。
讨论
这项随机对照试验将研究运动加基于SCT的行为改变干预对MS患者步行能力的有效性。为此，“加速行动”将为MS患者可持续运动干预的未来研究和临床实践方向提供信息。
试验注册
ClinicalTrials.gov，NCT02301442。
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