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临床试验/NCT07297381
NCT07297381进行中(未招募)不适用

Neuromuscular Electrical Stimulation and Action Observation for Healthy Aging: a Home-based Approach to Promote Sensorimotor Adaptation

Ambra Bisio1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年11月2日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
39
试验地点
1
主要终点
Estimated maximal power

研究概览

简要总结

Aging is associated with a decline in muscle strength and the functionality of the perceptual structures involved in proprioception. This decline results in a gradual loss of autonomy in daily activities. Neuromuscular electrical stimulation (NMES) has been shown to be an effective technique in limiting the decline in strength. Action observation (AO) is a cognitive technique, which has been shown to improve motor performance, especially when combined with peripheral stimulation.

The purpose of this study is to evaluate whether a self-administered, home-based intervention combining NMES and AO improves upper limb muscle strength and proprioceptive abilities in healthy elderly individuals.

Participants within the age range of 65-85 years will be recruited for this study. The intervention is scheduled to span a duration of four weeks, encompassing three treatment sessions per week. Participants will be randomly divided into three groups: NMES, AO, and AO-NMES. Assessments will be performed before and immediately after the intervention. They will include muscle strength evaluation (handgrip strength, maximal isometric force of the biceps, bench press power), and perceptual evaluation (weight discrimination during an AO task, weight judgment tasks).

This study may suggest an original approach, cost-effective approach to mitigate the effects of physiological aging on muscle and sensorimotor function, with potential applications for frail populations, unable or unmotivated to perform conventional physical activity.

详细描述

Aim The purpose of study will be testing the effects of a self-administered, home-based intervention combining NMES and AO for the upper limbs in healthy elderly people on muscle strength and proprioceptive abilities. This will be done by comparing action observation-neuromuscular electrical stimulation (AO-NMES) with action observation (AO) and neuromuscular electrical stimulation (NMES) delivered alone, with the hypothesis that AO-NMES leads to higher improvement than the others. This approach could be a safe, accessible and cost-effective way to maintain or improve neuromuscular function and sensorimotor control in ageing populations. Furthermore, by preserving upper limb function, the intervention could help older adults to retain functional autonomy, reduce their risk of disability and improve their overall quality of life and well-being.

Methods

  1. Participants Voluntarily participants will be recruited from the students enrolled in the 'UniGeSenior' program at the University of Genoa. The inclusion criteria are voluntarily participation, age ranges from 65 to 85 years, both male and female, sedentary. Exclusion criteria include neurological or psychiatric disorders, fractures within the past six months, orthopedic or musculoskeletal impairments, uncontrolled hypertension, and regular resistance training (at least once per week), participation in competitive sports.
  2. Study design This will be a randomized, double-blind, controlled experimental trial. The study will be registered on ClinicalTrials.gov. The intervention will last four weeks, three sessions per weeks will be performed at home. The intervention will vary according to the assigned group, with all interventions delivered in parallel across the following groups: AO group, NMES group and AO-NMES group. The assignment will be done using the RAND() function in Excel, which generated random numbers that were then used to sort and allocate subjects evenly. During each session, the treatment will last 30 minutes and will include a 10-minutes warm-up phase during which the visual task will be administered, and 20 minutes of exercise phase.

Before (PRE) and after (POST) the intervention period participant will perform different kinds of assessments (see Evaluation section). 3. Intervention 3.1. Visual stimuli

The stimuli shown to the participants will change according to the group. In the AO group participants will watch a video showing different instrumental activities of daily living (IADLs), which require considerable force production, executed with the upper limbs by a woman or a man. The IADLs will involve the individual performing the following tasks:

  • Moving a box forward or backward while sitting on a chair
  • Lifting a box onto or bringing it down from a support while standing upright
  • Placing a box onto or removing it from a shelf while standing upright
  • Moving a box from left to right or right to left while sitting on a chair
  • Moving a shopper from right to left or left to right while standing upright
  • Placing a shopper on a shelf or taking it down from a standing position
  • Holding a shopper while remaining upright The same AO task will be proposed to the AO-NMES group. Participants of the NMES group will observe changing landscapes. The visual stimuli will be administered through a tablet (Smartpad 9 Mediacom, Datamatic S.p.A, Milano, Italy) provided to the participants.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • sedenteary peole

排除标准

  • neurological or psychiatric disorders
  • fractures within the past six months
  • orthopedic or musculoskeletal impairments
  • uncontrolled hypertension
  • regular resistance training (at least once per week)
  • participation in competitive sports

结局指标

主要结局

Estimated maximal power

时间窗: Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

Power expressed while performing a bench press exercise. This will be evaluated during the "Strength and power assessment "

Maximal isometric strength

时间窗: Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period

Maximal isometric strength expressed during a isometric curl with the upper limbs. This will be evaluated during "Strength and power assessment "

次要结局

  • Error in the estimation of box weigth(Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period)
  • Just noticeble difference (JND)(Assessments will be conducted at two time points: (1) baseline (PRE), prior to the start of the intervention, and (2) post-intervention (POST), immediately after completion of the 4-week intervention period)

研究者

发起方
Ambra Bisio
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ambra Bisio

Professor

University of Genova

研究点 (1)

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