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临床试验/NCT04969094
NCT04969094进行中(未招募)不适用

Reducing Fall Risk With the Use of Neuromuscular Electrical Stimulation to Maximize the Hip Abductor Muscles in Older Veterans

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2022年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
81
试验地点
1
主要终点
Balance

研究概览

简要总结

Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ultimately reduce the risk of falls in older Veterans at high risk for falls.

详细描述

Falls are a leading cause of disability in older adults. Decreased lower extremity muscle mass and strength contribute to balance and mobility limitations. More recent work also suggests that in addition to the traditional targets of muscle mass of the thigh and leg muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip abductor strength, lower balance scores, increased gait variability (a predictor of future falls), and poor stepping mechanics when recovering from a balance perturbation. Increased IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle recruitment and make changing these muscle during a traditional intervention difficult. Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength and quality in older adults, but has not traditionally been used on the hip abductors. The investigator's central hypothesis is that the addition of NMES applied to the primary hip abductors during a multimodality balance intervention (MMBI) will result in greater reduction in fall risk and larger improvements in muscle and mobility function than MMBI alone. The investigators will test this hypothesis with the following specific aims:

Aim 1: To determine the 3-month effects of a multimodality balance intervention with and without NMES on fall risk.

Aim 2: To examine the 3-month effects of a multimodality balance intervention with and without NMES on functional outcomes including muscle function and composition.

Aim 3: To evaluate the retention of balance, muscle changes and reduced falls after a multimodality balance intervention with and without NMES

研究设计

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

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55 years or older
  • At risk for falls

排除标准

  • Poorly controlled hypertension
  • Home oxygen use
  • Contraindications to resistance exercise
  • Contraindications for NMES use
  • Other medical condition precluding patient participation in this study as per medical judgment of study team

研究组 & 干预措施

MMBI

Active Comparator

Participation in a multi-modality balance intervention

干预措施: Multi-Modality Balance Intervention (MMBI) (Other)

NMES + MMBI

Experimental

Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention

干预措施: Multi-Modality Balance Intervention (MMBI) (Other)

NMES + MMBI

Experimental

Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention

干预措施: Neuromuscular electrical stimulation (NMES) (Other)

结局指标

主要结局

Balance

时间窗: 3-months

The four-square step test will be used as a measure of balance. The change in the amount of time it takes to complete the four-square step test comparing pre and post-intervention.

Isometric Hip Abductor Strength

时间窗: 3-months

A measure of the maximal isometric muscle strength produced in hip abductor muscles will be assessed with a biodex device. Pre-test levels will be compared to post-intervention levels.

次要结局

  • Muscle composition(3-months)
  • Isometric Hip Abductor Strength(12-months after Exercise completion)
  • Mobility(3-months)
  • Balance(12-months after Exercise completion)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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