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临床试验/NCT03297632
NCT03297632Unknown不适用

Functionally Designed Resistance Exercise With the Aim of Improving Balance, Muscle Strength, Muscle Mass and Physical Function of the Elderly: a Randomized Controlled Study

Region Västerbotten2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年9月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
210
试验地点
2
主要终点
Change in Gait Speed

研究概览

简要总结

Falls and fractures are serious and costly events for elderly individuals: they cause functional impairments, increase mortality and contribute to huge healthcare costs for the society. The number of falls, and following consequences, are expected to increase in society as the proportion of the elderly population will increase, therefore it is crucial to be able to detect and prevent falls and fractures in the population. The investigators have previously published results that objective measurements of postural balance can predict fall risk in 70-year-olds in Umeå and subsequently investigated whether balance can be improved through 4-week balance exercise program. However, preliminary results suggest that the frequency and duration of exercise should be longer than 3 times a week for 4 weeks to produce effects. Furthermore, there is also evidence indicating a link between muscle weakness and fall risk in elderly subjects, while research findings show that it is possible for older individuals to influence muscle strength and muscle mass with resistance exercise. Functional strength training can also positively influence the balance. In this context, the investigators aim to investigate whether a 10-week resistance exercise program may positively affect balance, muscle strength, muscle mass and physical function, with the aim of preventing future falls and fractures in the population.

详细描述

Background:

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 of potential fall risk markers is of importance when predicting individuals at risk for falls and subsequently for improving strategies in fall-prevention. 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, which has advantages over regular clinical assessments since it reduces test performance variability and avoids the subjective nature of scoring systems. Recently, researchers has analyzed the performance of the Wii Balance Board (WBB) as an instrument for measuring postural instability, revealing excellent concurrent validity and an ability to complement existing fall assessments. However, these findings needed to be evaluated in a population-based sample with a rich set of covariates. Hence, the investigators performed a prospectively observational study to investigate how objective measures of postural sway predicted prospective falls in a cohort of more than 1800 community-dwelling men and women, all of whom were 70 years of age at the time of the investigation.

The results revealed that impaired postural stability can increase the risk of incident falls by 75 to 90% among older adults in the highest quintile of postural sway, measured during trials of both eyes open and eyes closed. One of the conclusions was that it would be valuable to examine the clinical utility of the investigated parameters in future studies, compare performance to established clinical balance tests, and to investigate whether strategies to improve balance would reduce the fall risk. Thus, in a follow-up study the investigators examined wether they could reduce the increased postural sway of participants who was identified as having abnormal balance values, based on previous measurements. The investigators also examined participants' functional balance through Time-Up-and-GO (TUG) performance, together with measures of muscle strength and validated questionnaires on Fear of Falling and Falls Efficacy. This follow-up study was conducted as a randomized intervention study, with a total of 52 individuals recruited from the existing HAI study cohort, with measures of postural sway in the 5th quintile, which indicated impaired balance function. The intervention group performed three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks while the control group received a health consultation highlighting the importance of physical activity and balance exercise. Preliminary data indicated that the exercise intervention had little to no effect on selected measures on balance, strength and physical function. Thus, it may seem that a exercise volume of 4 weeks of progressive balance exercise, 3 sessions per week, might be to low to produce beneficial effects.

The results from this previous study indicated the need for a more comprehensive exercise program in order to produce beneficial effects on balance, strength and physical function, and in the long term, fall prevention. Previous research has shown that low muscle strength together with low muscle mass, also known as sarcopenia, independently predicts falls, fractures and overall poor health. However, a growing body of evidence also indicates that older individuals are able to counteract the trend of age-related loss of muscle mass, as well as improve dynamic balance, through the use of resistance exercise. For older individuals, it is recommended that the exercise regimen lasts for 10-12 weeks, with 3 exercise sessions each week, in order to produce effects on muscle strength, muscle mass and physical function, which is a higher total exercise volume than what was used in the balance exercise study.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
70 Years 至 70 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participation in the Healthy Ageing Initiative (HAI) study
  • Appendicular lean mass index in the lowest 20% measured with the iDXA in the HAI study, separate for men and women.

排除标准

  • Unable to be present during all 10 weeks of exercise.

结局指标

主要结局

Change in Gait Speed

时间窗: Change in Gait Speed at 10 and 34 weeks

Gait speed measurement task from the Short Physical Performance Battery (SPPB). Measured in the seconds it takes to walk 4 meters.

Change in Chair Stand performance

时间窗: Change in Chair stand performance at 10 and 34 weeks

Chair stand measurement task from the Short Physical Performance Battery (SPPB). Measures in the time it takes to stand up 5 times.

Change in Postural Stability performance

时间窗: Change in Postural Stability performance at 10 and 34 weeks

Postural stability measurement task from the Short Physical Performance Battery (SPPB), containing bipedal, semi-tandem and tandem stances. Measured in seconds, up to a maximal value of 10 seconds.

次要结局

  • Change in Postural Sway(Change in Baseline Postural Sway at 10 and 34 weeks)
  • Change in TUG test performance(Change in Baseline TUG test performance at 10 and 34 weeks)
  • Change in Physical Activity(Change in Baseline Physical Activity at 10 and 34 weeks)
  • Change in self-recalled Physical Activity(Change in Baseline self-recalled Physical Activity at 10 and 34 weeks)
  • Change in Isometric Muscle Strength(Change in Baseline Isometric Muscle Strength at 10 and 34 weeks)
  • Change in Fear of Falling(Change in Baseline Fear of Falling at 10 and 34 weeks)
  • Change in Appendicular Muscle Mass(Change in Baseline Appendicular Muscle Mass at 10 and 34 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 (2)

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