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临床试验/NCT03227666
NCT03227666已完成不适用

The Effect of Progressive Balance Exercise on Postural Sway - a 4 Week Randomized Controlled Trial

Region Västerbotten1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Change in Postural Sway

研究概览

简要总结

Today most fracture prevention measures targets the bone and osteoporosis. However, only about 20% of individuals with fractures have osteoporosis and at least 90% of all fractures are caused by a fall. Therefore, the present project builds on previous findings from our group identifying postural sway as an important risk factor for falls and aims to intervene against this risk factor in a randomized controlled trial targeting subjects at the highest risk for falls.

详细描述

Specific aims:

  1. Examine whether four weeks progressive balance training can improve parameters of body sway in measurements of static standing balance
  2. Investigate whether participants experience greater security to their own ability and less fear of future falls after 4 weeks of progressive balance training
  3. Investigate how long a potential effect of progressive balance training may be noticeable on participants' experiences of greater security in their own ability and less fear of future falls
    1. Examine whether participation in balance training leads to reduced number of falls at follow-up after 6, 12 and 24 months

Falls and fall-related injuries are major health concerns for elderly individuals; they cause functional decline and increased mortality, as well as incurring vast health care costs for society. Occurrences and consequences of falls are expected to increase globally with the growing number of elderly individuals. Hence, the improved detection and prediction of potential fall risk markers are of individual and societal importance.

Falling can be the end result of intrinsic and extrinsic factors negatively affecting an individual's ability to maintain balance, which are often revealed during sequences of body movement. Balance can be both dynamically and statically measured, the latter involves having the individual in a stationary standing position, from which results researchers have proposed impaired postural stability as a risk factor for falling. However, evidence regarding the association of postural instability with prospective falls is limited, and population-based cohort studies in this field are scarce. Other shortcomings of previous studies include the use of retrospective study designs, which increase the risks of recall bias and the identification of risk factors as the result of falls.

Postural instability is preferably investigated using objective measures of posturography, the advantages of which over regular clinical assessments include the reduction of test performance variability and avoidance of subjective scoring systems. Recently, researchers have analyzed the performance of the Wii Balance Board (WBB; Nintendo, Kyoto, Japan) in the measurement of postural instability; WBB-based assessment has shown excellent concurrent validity and the ability to complement existing fall assessments.

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

性别
All
接受健康志愿者
否

入选标准

  • •Participation in the HAI study, having postural sway > 400 mm during Eyes Open trial or > 920 mm during Eyes Closed trial

排除标准

  • •Walking aid

研究组 & 干预措施

Intervention Group

Experimental

The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.

干预措施: Exercise (Behavioral)

Control group

No Intervention

The control group recieves a health consultation that highlights the importance of physical activity and balance exercise according to standard practice within the HAI project. They are asked to return after 4 weeks for follow up.

结局指标

主要结局

Change in Postural Sway

时间窗: Change in Baseline Postural Sway at 4 weeks

Total postural sway length, measured objectively during trials of eyes open and eyes closed, during 60 seconds each

次要结局

  • Change in Fear of Falling (FOF)(Change in Baseline FOF at 4 weeks)
  • Prospective Falls(6,12 and 24 months after intervention)
  • Change in Time-up-and-go (TUG) Performance(Change in Baseline TUG Performance at 4 weeks)
  • Change in Balance Self-efficacy(Change in Baseline Balance Self-efficacy at 4 weeks)
  • Change in Muscle Strength(Change in Baseline Muscle Strength at 4 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anna Nordström

Adjunct Professor

Region Västerbotten

研究点 (1)

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