Clinical trial NCT05735405: Aerobic Exercise and Cognitive Training in Patients With Stroke
Official title: Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: BDNF
Aerobic Exercise
Cognitive Training
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychological test scores
timeFrame: Change in the neuropsychological test scores at 1 month
Secondary outcomes:
measure: Number of errors committed in the cognitive exercises
timeFrame: One month
Other outcomes:
Locations:
city: Rovato
country: Italy
facility: Centro Ettore Spalenza- Fondazione Don Gnocchi
state: Brescia
Study officials:
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