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临床试验/NCT02314585
NCT02314585Unknown不适用

Fall Risk Reduction in Multiple Sclerosis: Exercise Intervention vs. Attention Control Modification

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Chagne in Fall Risk

研究概览

简要总结

This study looks to see the effects of a home based exercise program on falls in people with MS.

详细描述

The purposes of this project are four-fold: 1) to determine if a 6-month home-based targeted exercise program results in immediate and sustained reduction in falls risk and incidence ; 2) to identify the factors that contribute to a reduction in fall risk and incidence; 3) to determine if a decrease in physiological fall risk and/or fall incidence results in increased quality of life and participation in older adults with MS; and 4) to determine the association between cognition, environment and comorbidities on future falls and intervention efficacy.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The inclusion criteria involve having an established definite diagnosis of MS
  • •Ability to walk 25 feet with or without aid
  • •Relapse free in the last 30 days
  • •Being ≥ 50 years of age
  • •Having fallen at least once in the past year
  • •Physician approval to engage in light physical activity
  • •Willingness and ability to attend the training sessions and testing sessions.

排除标准

  • •We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.
  • •During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.
  • •Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.

研究组 & 干预措施

Education

Other

In the second phase, participants will partake in an instructional class relating to gait, balance, and falls.

干预措施: Education (Other)

Exercise

Other

In the second phase,participants will partake in an exercise course relating to gait, balance, and falls.

干预措施: Exercise (Other)

结局指标

主要结局

Chagne in Fall Risk

时间窗: 1 year

The primary outcome measure of this investigation is physiological fall risk. Physiological fall risk will be determined by the short form of the physiological profile assessment (PPA). The PPA is a validated tool to assess physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function. It is predictive of future fall risk in persons with MS. The PPA provides a fall risk score that is based on the quantification of key physiological markers (e.g. vision, leg strength, proprioception, balance, cognition, etc) and comparison of those markers to age and gender matched normative data. The PPA provides a therapeutically relevant prognostic predictor of falls and this makes it an ideal outcome measure of investigations evaluating fall prevention strategies.

次要结局

  • Identification of Fall Risk Factors(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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