Coote Susan, Garrett Maria, Hogan Neasa, Larkin Aidan, Saunders Jean
Department of Physiotherapy, University of Limerick, Limerick, Ireland.
BMC Neurol. 2009 Jul 16;9:34. doi: 10.1186/1471-2377-9-34.
People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS.
This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don't change their exercise habits.Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don't change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control), and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test and the Modified Ashworth Scale. Confounding variables such as sensation, coordination, proprioception, range of motion and other impairments will be recorded at initial assessment.
Data analysis will analyse change in each group, and the differences between groups. Sub group analysis may be performed if sufficient numbers are recruited.
ISRCTN77610415.
由于多发性硬化症具有进展性，且患者因缺乏运动而出现并发症的风险更高，因此他们终生都需要物理治疗和运动干预。爱尔兰多发性硬化症协会为其成员开设了物理治疗、瑜伽和运动课程，然而，几乎没有证据表明哪种体育活动形式能使与多发性硬化症相关的多种不同损伤的患者获得最佳治疗效果。
这是一项多中心、单盲、区组随机对照试验。参与者将通过爱尔兰多发性硬化症协会的十个地区办事处招募。电话筛查将根据盖伊神经功能障碍量表的活动能力部分确定资格并进行分层。一旦同一地理区域内同一组别的一群人同意参与，参与者将被随机分组。A组将包括能够独立行走或在户外行走时使用单根拐杖的多发性硬化症患者。参与者将被随机分配到瑜伽组、物理治疗师指导的运动课程组、健身教练指导的运动课程组或不改变运动习惯的对照组。B组将包括需要双侧支撑或使用助行器行走的多发性硬化症患者，他们在户外行走较长距离时可能会使用轮椅。参与者将被随机分配到一对一的物理治疗师主导的干预组、物理治疗师主导的小组干预组、小组瑜伽干预组或不改变运动习惯的对照组。在第1周、第12周（经过10周的干预或对照）以及12周随访时，由对分组情况不知情的物理治疗师对参与者进行评估。两组的主要结局指标均为多发性硬化症影响量表。次要结局指标包括改良疲劳影响量表、6分钟步行试验以及用手持测力计测量的肌肉力量。B组还将使用伯格平衡量表和改良Ashworth量表。在初始评估时将记录感觉、协调、本体感觉、活动范围和其他损伤等混杂变量。
数据分析将分析每组的变化情况以及组间差异。如果招募到足够数量的参与者，可能会进行亚组分析。
ISRCTN77610415。
