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经颅直流电刺激和多组分训练对老年人功能能力的影响:一项随机、对照、双盲临床试验方案。

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial.

机构信息

Postgraduate Program in Rehabilitation Sciences, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.

Physiotherapy Course, Nove de Julho University (UNINOVE), São Paulo, SP, Brazil.

出版信息

Trials. 2020 Feb 19;21(1):203. doi: 10.1186/s13063-020-4056-2.

Abstract

INTRODUCTION

When physical activity contains training of at least three components such as balance, coordination and strength, among others, it is called multicomponent training. This type of training is recommended for improving the functional capacity in elderly individuals but has no lasting effects. The association of transcranial direct current stimulation (tDCS) with other types of therapy has been shown to facilitate the enhancement and prolongation of therapy outcomes.

AIM

The objective of this study is to evaluate the effect of multicomponent training associated with active or sham tDCS on the performance of functional capacity in the elderly before treatment, after treatment and 30 days after the end of treatment. The secondary objective will be to correlate the performance of the primary outcome (functional capacity assessed by the Glittre Daily Life Activity Test) with walking capacity (by 6-min walk test), balance (with the mini-Balance Evaluation Systems Test), functional independence (by the Functional Independence Measure) and quality of life (with the World Health Organization Quality of Life Instrument).

METHODS

Twenty-eight elderly people from the community will participate in the study, and will be randomized into two groups: 1) multicomponent training associated with active tDCS; and 2) multicomponent training associated with sham tDCS. The multicomponent training sessions will be held twice a week for 12 weeks, totaling 24 sessions. The tDCS will be administered over the dominant dorsolateral prefrontal cortex at the same time as multicomponent training, with an intensity of 2 mA, for 20 min. The evaluations will be made pretraining, after 24 training sessions and 30 days after the end of the training.

DISCUSSION

We hypothesize that tDCS, when associated with multicomponent training, can potentiate and prolong the effects of this training on the functional capacity of the elderly. If this hypothesis is confirmed, this protocol may contribute to a longer-lasting physical rehabilitation of the elderly, encouraging them to maintain their independent daily activities for longer.

TRIAL REGISTRATION

The study was registered in the Brazilian Clinical Trial Registry (RBR-2crd42) and received approval from the Human Research Ethics Committee of University Nove de Julho, São Paulo, Brazil (process number 3.077.953).

摘要

介绍

当身体活动包含平衡、协调和力量等至少三个组成部分的训练时,就称为多组分训练。这种类型的训练被推荐用于提高老年人的功能能力,但没有持久的效果。经颅直流电刺激(tDCS)与其他类型的治疗相结合,已被证明可以促进治疗效果的增强和延长。

目的

本研究的目的是评估多组分训练与主动或假 tDCS 联合治疗对治疗前、治疗后和治疗结束后 30 天老年人功能能力的影响。次要目标是将主要结局(通过 Glittre 日常生活活动测试评估的功能能力)的表现与步行能力(通过 6 分钟步行测试)、平衡能力(通过 mini-Balance 评估系统测试)、功能独立性(通过功能独立性测量)和生活质量(通过世界卫生组织生活质量工具)相关联。

方法

社区中的 28 名老年人将参与该研究,并将被随机分为两组:1)多组分训练与主动 tDCS 联合治疗;2)多组分训练与假 tDCS 联合治疗。多组分训练课程将每周进行两次,共 12 周,共 24 次。tDCS 将在多组分训练的同时施加于优势背外侧前额叶皮层,强度为 2 mA,持续 20 分钟。评估将在训练前、24 次训练后和训练结束后 30 天进行。

讨论

我们假设 tDCS 与多组分训练联合使用,可以增强和延长这种训练对老年人功能能力的影响。如果这一假设得到证实,该方案可能有助于老年人的身体康复更持久,鼓励他们更长时间地保持独立的日常活动。

试验注册

该研究在巴西临床试验注册处(RBR-2crd42)注册,并获得了巴西诺瓦德茹尼奥尔大学人类研究伦理委员会的批准(编号 3.077.953)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb10/7031910/f89a676862b2/13063_2020_4056_Fig1_HTML.jpg

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