Hemorrhagic Stroke, Ischemic Stroke
Conditions
Keywords
BDNF, Aerobic Exercise, Cognitive Training
Brief summary
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.
Interventions
BEHAVIORALNeuropsychological evaluation
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.
BIOLOGICALBDNF evaluation
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).
BEHAVIORALPedaling as a moderate intensity aerobic exercise
During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.
OTHERCognitive Training
During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions.
DIAGNOSTIC_TESTVO2 assessment
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.
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological test scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of errors committed in the cognitive exercises | One month | 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. |
Countries
Italy
Outcome results
None listed