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临床试验/NCT05735405
NCT05735405招募中不适用

Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke

Fondazione Don Carlo Gnocchi Onlus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Neuropsychological test scores

研究概览

简要总结

The goal of this clinical trial is to test the effects of aerobic exercise and BDNF on patients with ischemic and hemorrhagic stroke during a computerized cognitive training.

The main questions it aims to answer are:

  1. Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
  2. Is it possible to exploit the timing of rehabilitation interventions to obtain greater effects? Participants will be divided in 2 groups. The experimental group will first perform 20 minutes of pedaling as a moderate intensity aerobic exercise. It will then participate in one-hour cognitive training sessions, with the aim of training attentional, working memory and executive functions. The control group will carry out the same interventions but in reverse order.

The researchers will compare the results of the cognitive training in the two groups to verify if the order of the interventions influences the results themselves.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a clinical diagnosis of stroke, both ischemic and haemorrhagic.
  • Patients admitted to the Specialist Rehabilitation Unit 1 of the "E. Spalenza - Don Gnocchi "of Rovato.
  • Overall score in the MoCA test ³ 26
  • In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with score in the norm, P.E. > 1
  • Hypertonic and spasticity picture compatible with the performance of motor activity of pedaling expected in the EA session.
  • Tolerance of physical exercise
  • Incoming electrocardiogram normal and free of anomalies

排除标准

  • Overall score in the MoCA test <26
  • In case of a diagnosis of aphasia, a test of verbal comprehension ("Token Test") with pathological or borderline score, P.E. £
  • Documented diagnosis of neurodegenerative diseases with impact on performance cognitive.
  • Severe acquired brain injury
  • Illiteracy
  • Status of hypertonus and spasticity not compatible with the performance of motor training
  • Excessive fatigue: the patient does not tolerate moderate intensity physical activity and accuses excessive fatigue during the preliminary test
  • Electrocardiogram at entrance with anomalies and / or altered
  • Ischemic heart disease
  • Cardiac disorders that are contraindications for aerobic activity of moderate intensity

结局指标

主要结局

Neuropsychological test scores

时间窗: Change in the neuropsychological test scores at 1 month

The experimental hypothesis is to obtain better scores in the experimental group on the neuropsychological tests used. T-tests and delta scores will be used to determine the quantitative change in the score.

次要结局

  • Number of errors committed in the cognitive exercises(One month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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