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临床试验/NCT01956227
NCT01956227已完成1 期

Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
37
试验地点
1
主要终点
Fall incidence

研究概览

简要总结

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

详细描述

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.

It is well known that causes of falls are multifactorial with over 400 risk factors identified. However, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. For instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in MS . Behavioral fall risk factors in MS include choosing appropriate footwear, lighting and utilizing appropriate assistive device. There is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with MS and have been shown to reduce fall risk and incidence in other clinical populations. This has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with MS. However, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with MS. This proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with MS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Definite multiple sclerosis diagnosis
  • •ambulatory
  • •aged 50-75 years of age
  • •fallen within 12 months

排除标准

  • •non-ambulatory
  • •outside age range
  • •no fall history

研究组 & 干预措施

Home-based Exercise

Experimental

Participants will be taught a series of exercises targeting balance and lower limb strength in four instructional sessions. They will be asked to complete exercises 3 times a week for 12 weeks. Exercise compliance will be recorded with a diary.

干预措施: Home-based exercise (Behavioral)

Education

Experimental

Participants will attend 4 education sessions focusing on interaction of beliefs, behaviors and symptoms on falls. They will be taught self-management principles to modify their fall risk.

干预措施: Education (Behavioral)

Exercise plus education

Experimental

Participants will attend 2 instructional exercise sessions as well as 2 education sessions. Participants will be asked to complete exercises at home 3 times per week and engage in behavior to minimize fall risk.

干预措施: Exercise plus Education (Behavioral)

Control

No Intervention

Participants will not receive any treatment.

结局指标

主要结局

Fall incidence

时间窗: 3 months

次要结局

  • Physiological Fall Risk(3 Months)
  • Mobility(3 months)
  • Balance(3 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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