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临床试验/NCT01113879
NCT01113879已完成不适用

Exercise as an Adjuvant to Aphasia Therapy

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2009年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
4
主要终点
Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means

研究概览

简要总结

The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity.

详细描述

The objective of this research project is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities with treatment than patients who do not participate in aerobic activity. As secondary objectives, we will determine if there is a direct relationship between either brain efficiency or increases in Brain Derived Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Post-stroke aphasia
  • at least 6 months post-stroke
  • at least minimally intact auditory verbal comprehension
  • pre-morbidly right handed
  • native English speaker

排除标准

  • contraindications for fMRI (metal implants, claustrophobia)
  • inability to pass an exercise tolerance test
  • significant depression
  • uncorrected hearing or vision problems
  • severe apraxia of speech
  • regularly perform 20 minutes of cardiovascular exercise 3 times per week

研究组 & 干预措施

Aphasia therapy with an exercise adjuvant

Experimental

Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Aerobic exercise: An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.

干预措施: Aerobic exercise (Behavioral)

Aphasia therapy with a stretching adjuvant

Placebo Comparator

Aphasia therapy for anomia: The treatment is a traditional lexical/semantic stimulation approach during which subjects will attempt to name drawings of objects.

Stretching: Stretching will occur for 50 minutes a day, three days/week for 12 weeks.

干预措施: Stretching (Behavioral)

结局指标

主要结局

Change in Picture Naming Abilities as Measured by Tau U Effect Size Weighted Means

时间窗: administered before and after each of two, two week aphasia therapy blocks

Tau-U effect sizes of \<0.20 were considered small; 0.20 to \<0.60 moderate; 0.60 to \<0.80 large, and \>=0.80 very large. Weighted Tau-U averages in exercise participants and stretching participants were calculated in each block using an online web-based calculator (http://www.singleresearch.org/calculators/tau-u). In the present analysis, any baseline trends over 0.10 were adjusted.

次要结局

  • Change in Serum Brain-derived Neurotrophic Factor (BDNF) Levels With Exercise(six samples collected over a 16 week period)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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