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临床试验/NCT07429526
NCT07429526已完成不适用

Does Aerobic Exercise Affect Memory, Attention, Working Memory, and Fatigue After Acquired Brain Injury? A Single-Blinded, Randomized Controlled Pilot Study

Danderyd Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Memory

研究概览

简要总结

Acquired brain injury can affect cognition and cause fatigue. Aerobic exercise has been linked to improved cognition in the general population. This is thought to occur through boosting neuroplasticity, that is to say the brain's ability to change and adapt. Investigators explored the effects of aerobic exercise after acquired brain injury and investigated if any changes on the brain could be detected. This was done through an 8-week period of 30 min of aerobic exercise, 3-4 times a week for a group of 6 participants compared with 6 participants that did their usual training. Magnetic resonance imaging was used to detect any changes on the brain.

详细描述

The objective is to study the effects of aerobic exercise on cognitive function, fatigue and neuroplasticity after stroke or traumatic brain injury with a randomized controlled pilot study. Subjects were patients aged 16-65 years with moderate to severe stroke or traumatic brain injury at least 3 months post injury. The intervention group participated in 30 min of aerobic exercise 3-4 times/week for 8 weeks during their outpatient rehabilitation. The control group received routine physical therapy. In addition, both groups received rehabilitation according to their rehabilitation plan. Neuropsychological and endurance testing was performed before and after the intervention and at a 3 month follow up. Magnetic resonance imaging was performed before and after the intervention.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • - First stroke/TBI with CT/MRI verified injury, (moderate to severe brain injury)
  • Age 18-65 years
  • at least 3 months after injury
  • Fluent in Swedish Selection criteria
  • Cognition:
  • one standard deviation (SD) below age adjusted normal in at least one of the following tests: verbal memory, visual memory, working memory or attention
  • be able to follow instructions during neuropsychological (NP) testing.
  • be able to reach 60-80% of estimated maximal heart rate (HRmax= 220-age) during aerobic testing and training

排除标准

  • - Severe heart disease
  • Cognitive defects, not due to the actual stroke or TBI
  • Moderate depression/anxiety, defined as >10 respectively on HADS
  • Severe aphasia
  • Not fulfilling criterias for MRI (such as pregnancy, having metal parts implanted in the body, afraid of cramped spaces)

研究组 & 干预措施

Aerobic exercise

Experimental

30 min of AE, 3-4 times/week for 8 weeks,

干预措施: exercise (Other)

Control

No Intervention

rehabilitation according to rehabilitation program, not including aerobic training

结局指标

主要结局

Memory

时间窗: From enrolment to the end of participation at 8 weeks and at a 3 month follow up

Memory, measured by the following test: Rey Auditory Verbal Learning Test (RAVLT), a test of verbal learning and long-term memory (25). The RAVL Test consists of a 15 noun-word list (list A) that is read to the participants. After the presentation of list A, the participant is requested to recall as many words as possible. The procedure is repeated 5 times, and after each trial recall is recorded and all five recall trials are summed into one score (= immediate recall score). After 5 presentations of list A, an interference-list of 15 other nouns (list B) are read and the participants are asked to recall as many words as possible. Immediately after the recall of list B, the participants are again asked to recall list A. Delayed recall of list A is measured 30 min after the immediate recall (= delayed recall score). The higher the value the better result.

Executive functions

时间窗: From enrolment to the end of participation at 8 weeks and at a 3 month follow uo

Executive functions measured by the following test: Kaplan executive function system (D-KEFS) Color Word Test, measures the ability to inhibit automized verbal responses and the ability to use cognitive shifting. The test has four conditions: 1) naming the colors of squares (red, blue or green, 2) reading color words printed in black, 3) naming the printed color of the color words red, blue, or green printed in a different color, which means inhibition of an over-learned function of reading the word; 4) repeatedly switching between a) naming the printed color of the color words red, blue, or green and b) reading the words as quickly as possible. In this condition the person needs to keep track of clues that indicate rule change. Sub tests 1 and 2 are contrast tests and used for comparison between the sub tests 3 and 4 i.e. the more complex tasks. The faster the time, the better which give that lower values represent better results.

Attention

时间窗: From enrolment to the end of participation at 8 weeks and at a 3 month follow up

Attention measured by the following tests: Paced Auditory Serial Addition Test (PASAT) Measures auditive processing speed, attention, and working memory. The test consists of 60 digits from 1-9 presented at a standardized pace of 2.4 seconds between each digit. The task is to sum each digit with the previously presented one before the next digit is presented. The test was presented according to the manual. The maximum score is 60. This test was also used to measure cognitive fatigability as declining performance in terms of an increased number of incorrect responses on the PASAT. The responses were divided into five sections of 12 numbers each, where the number of correct answers in the first section was subtracted from the number of correct answers in the last section. Fatigability was defined as a lower score at the end of the test compared to the beginning, giving a negative value.

fatigue

时间窗: From enrolment to the end of participation at 8 weeks and at a 3 month follow up

Fatigability was defined as a lower score at the end of the Paced Auditory Serial Addition Test (PASAT) test compared to the beginning, giving a negative value

次要结局

未报告次要终点

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eyglo Ingolfsdottir

Physical Therapist

Danderyd Hospital

研究点 (1)

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