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临床试验/NCT03509519
NCT03509519Unknown不适用

Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults

Texas State University0 个研究点目标入组 30 人开始时间: 2018年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Change in Physical Activity

研究概览

简要总结

The purpose of this placebo controlled clinical trial is to examine the effects of of neuromuscular electrical stimulation (NMES) training on physical activity, muscle function, self-efficacy, and blood markers [e.g., brain-derived neurotrophic factor (BDNF)] in older adults.

It is hypothesized that 4-weeks of NMES will increase 1) physical activity, 2) muscle function, 3) self-efficacy, and 4) BDNF in older adults.

Sarcopenia is a destructive progressive cycle of impaired physical function resulting in loss of muscle mass, strength, and self-confidence in ability to perform physical activities, compounded by difficulty walking and ultimately reduced physical activity levels for many older adults. Neuromuscular electrical stimulation (NMES) is a common therapeutic modality used to create involuntary muscle contractions as a means to increase muscle strength, and may be an effective treatment for improving muscle function and physical activity levels in older adults with sarcopenia. Thus, it is critical to explore viable and effective alternative therapies to increase physical activity. The goal of the investigators' is to determine the effectiveness of neuromuscular electrical stimulation (NMES) at increasing physical activity and related biological, psychological, and muscle function factors. This placebo controlled clinical trial will use a pre-test - post-test randomized experimental design.

详细描述

Older healthy adults (60 and older) will participate in this study. Participants will undergo 4 weeks of neuromuscular electrical stimulation (NMES) training. Participants will be randomized into the one of two groups 1) NMES-millicurrent or 2) NMES microcurrent. Participants will undergo pre- and post-training testing for muscle function, physical function, and psychological variables related to physical activity. Blood samples will also be obtained pre- and post-training.

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 (Participant)

入排标准

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

入选标准

  • generally healthy men and women
  • ages 60 and older

排除标准

  • they have participated in regular resistance training exercise or physical rehabilitation of the lower extremity within 2 months of the study
  • contraindicating conditions for electrical stimulation are present (i.e., swollen, infected or inflamed areas including open wounds, or painful areas on the lower limbs, implanted electronics including cardiac pacemakers, electronic infusion pumps, implanted stimulators, or surgical hardware in the lower limbs)
  • they have current knee injury or knee pain
  • have a neuromuscular disease
  • currently taking insulin for diabetes regulation
  • they have a history of seizures

结局指标

主要结局

Change in Physical Activity

时间窗: Physical activity levels will be assessed for 1 week before the intervention and for 1 week after the intervention period. The change in physical activity will be compared between these two time-periods.

Physical activity will be measured from accelerometer data.

次要结局

  • Change in Muscle Endurance(Muscle endurance will be assessed prior to the first day of the intervention and 2 days after the completion of the 4-week intervention.)
  • Change in Muscle Strength(Muscle strength will be assessed prior to the first day of the intervention, after 2-weeks of the intervention, and two days after the completion of the 4-week intervention.)
  • Change in motor activation(Motor activation will be measured prior to the first day of the intervention and two days after the completion of the 4-week intervention.)
  • Change in stair climb test(The stair cimb test test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Change in arm curl test(The arm curl test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Pre-training NMES-related change in glucose(Blood glucose will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.)
  • Change in perception of pain(Perceptions of pain will be measured immediately after the NMES treatment on the first (training day 1) and last day (training day 12) of the 4-week intervention.)
  • Physical activity during the 4-week intervention(Physical activity levels will be measured during the 4 weeks of the intervention (from the first day of the intervention through the last day of the intervention).)
  • Change in 6-min walk test(The 6-min walk test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Pre-training NMES-related change in Brain-derived Neurotrophic Factor (BDNF) levels(BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.)
  • Change in self-efficacy of activities of daily living(Self-efficacy will be measured prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Change in five repetition sit-to-stand test(The five repetition sit-to-stand test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Change in timed up and go test(Timed up and go test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)
  • Post-training NMES-related change in glucose(Blood glucose will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.)
  • Post-intervention change in Brain-derived Neurotrophic Factor (BDNF) levels(BDNF levels will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.)
  • Change in grip strength(The grip strength test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.)

研究者

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

Joni Mettler

Assistant Professor

Texas State University

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