Aerobic Exercise and Cognitive Training in Patients With Stroke

Study Overview
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Brief Summary
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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: Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance? 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.

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

Conditions
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Ischemic Stroke, Hemorrhagic Stroke

Intervention / Treatment
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* Behavioral: Neuropsychological evaluation
* Biological: BDNF evaluation
* Behavioral: Pedaling as a moderate intensity aerobic exercise
* Other: Cognitive Training
* Diagnostic Test: VO2 assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. £ 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The experimental group will first perform 30 minutes of pedaling as a moderate intensity aerobic activity. Subsequently it will carry out a daily cognitive training of 60 minutes to improve attentional, working memory and executive functions. | Behavioral: Neuropsychological evaluation<br>* Each participant will undergo a complete neuropsychological evaluation, both before and at the end of the clinical trial, with the aim of detecting any changes or improvements.<br>Biological: BDNF evaluation<br>* During the first and last clinical trial session, each participant will undergo two blood samples, one before and one at the end of the ride, to check levels of Brain Derived Neurotrophic Factor (BDNF).<br>Behavioral: Pedaling as a moderate intensity aerobic exercise<br>* During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.<br>Other: Cognitive Training<br>* During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.<br>Diagnostic Test: VO2 assessment<br>* To determine the individual moderate intensity for each patient, a VO2 consumption assessment will be made. The examination will be carried out using an exercise bike and a mask for the calculation of metabolic oxygen consumption. The 3 MET threshold to reach in pedaling will be calculated (to define it of moderate intensity), in order to elicit the release of BDNF.<br>|
| Experimental: Control Group<br>The control group will first carry out a daily 60-minute cognitive training to improve attentional, working memory and executive functions. It will then perform 30 minutes of pedaling as a moderate intensity aerobic activity. | Behavioral: Neuropsychological evaluation<br>* Each participant will undergo a complete neuropsychological evaluation, both before and at the end of the clinical trial, with the aim of detecting any changes or improvements.<br>Biological: BDNF evaluation<br>* During the first and last clinical trial session, each participant will undergo two blood samples, one before and one at the end of the ride, to check levels of Brain Derived Neurotrophic Factor (BDNF).<br>Behavioral: Pedaling as a moderate intensity aerobic exercise<br>* During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.<br>Other: Cognitive Training<br>* During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.<br>Diagnostic Test: VO2 assessment<br>* To determine the individual moderate intensity for each patient, a VO2 consumption assessment will be made. The examination will be carried out using an exercise bike and a mask for the calculation of metabolic oxygen consumption. The 3 MET threshold to reach in pedaling will be calculated (to define it of moderate intensity), in order to elicit the release of BDNF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological test scores | 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. | Change in the neuropsychological test scores at 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of errors committed in the cognitive exercises | For each exercise used in the cognitive training, numerical data will be extrapolated to determine the number of errors committed and the progress achieved. T-tests will be carried out to verify if the experimental group had a better performance during the training than the control group. | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Training, BDNF, Aerobic Exercise