帕金森病患者的跌倒和活动能力：一项随机对照临床试验方案。
Falls and mobility in Parkinson's disease: protocol for a randomised controlled clinical trial.
机构信息
Melbourne School of Health Sciences, The University of Melbourne, 3010, Melbourne, Australia.
出版信息
BMC Neurol. 2011 Jul 31;11:93. doi: 10.1186/1471-2377-11-93.
BACKGROUND
Although physical therapy and falls prevention education are argued to reduce falls and disability in people with idiopathic Parkinson's disease, this has not yet been confirmed with a large scale randomised controlled clinical trial. The study will investigate the effects on falls, mobility and quality of life of (i) movement strategy training combined with falls prevention education, (ii) progressive resistance strength training combined with falls prevention education, (iii) a generic life-skills social program (control group).
METHODS/DESIGN: People with idiopathic Parkinson's disease who live at home will be recruited and randomly allocated to one of three groups. Each person shall receive therapy in an out-patient setting in groups of 3-4. Each group shall be scheduled to meet once per week for 2 hours for 8 consecutive weeks. All participants will also have a structured 2 hour home practice program for each week during the 8 week intervention phase. Assessments will occur before therapy, after the 8 week therapy program, and at 3 and 12 months after the intervention. A falls calendar will be kept by each participant for 12 months after outpatient therapy.Consistent with the recommendations of the Prevention of Falls Network Europe group, three falls variables will be used as the primary outcome measures: the number of fallers, the number of multiple fallers and the falls rate. In addition to quantifying falls, we shall measure mobility, activity limitations and quality of life as secondary outcomes.
DISCUSSION
This study has the potential to determine whether outpatient movement strategy training combined with falls prevention education or progressive resistance strength training combined with falls prevention education are effective for reducing falls and improving mobility and life quality in people with Parkinson's disease who live at home.
TRIAL REGISTRATION
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12606000344594.
背景
尽管物理治疗和跌倒预防教育被认为可以减少特发性帕金森病患者的跌倒和残疾，但这尚未通过大规模随机对照临床试验得到证实。本研究将调查运动策略训练结合跌倒预防教育、渐进式抗阻力量训练结合跌倒预防教育、一般性生活技能社会项目（对照组）对跌倒、活动能力和生活质量的影响。
方法/设计：将招募居住在家庭中的特发性帕金森病患者，并将其随机分配到三个组之一。每个人将在门诊环境中接受 3-4 人一组的治疗。每个组将按计划每周一次会面 2 小时，持续 8 周。所有参与者还将在 8 周干预阶段的每周进行一次结构化的 2 小时家庭练习计划。在治疗前、8 周治疗方案后以及干预后 3 个月和 12 个月进行评估。每位参与者在门诊治疗后 12 个月内将保留一份跌倒日历。根据预防跌倒网络欧洲小组的建议，将使用三个跌倒变量作为主要结局测量指标：跌倒者人数、多次跌倒者人数和跌倒率。除了量化跌倒外，我们还将测量活动能力、活动受限和生活质量作为次要结局。
讨论
本研究有可能确定门诊运动策略训练结合跌倒预防教育或渐进式抗阻力量训练结合跌倒预防教育是否可以有效减少居住在家中的帕金森病患者的跌倒次数，并改善其活动能力和生活质量。
试验注册
澳大利亚和新西兰临床试验注册（ANZCTR）：ACTRN12606000344594。
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