Aerobic Exercise and Cognitive Training in Patients With Stroke

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735405
• Other study ID #: Version 1; 01/09/22
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2022
• Est. completion date: May 2023

Study information

• Verified date: October 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• Neuropsychological 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.

Biological:
• BDNF 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).

Behavioral:
• Pedaling 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.

Other:
• Cognitive 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 Test:
• VO2 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.

Locations

Country	Name	City	State
Italy	Centro Ettore Spalenza- Fondazione Don Gnocchi	Rovato	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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Hwang J, Brothers RM, Castelli DM, Glowacki EM, Chen YT, Salinas MM, Kim J, Jung Y, Calvert HG. Acute high-intensity exercise-induced cognitive enhancement and brain-derived neurotrophic factor in young, healthy adults. Neurosci Lett. 2016 Sep 6;630:247-253. doi: 10.1016/j.neulet.2016.07.033. Epub 2016 Jul 20. — View Citation

Knaepen K, Goekint M, Heyman EM, Meeusen R. Neuroplasticity - exercise-induced response of peripheral brain-derived neurotrophic factor: a systematic review of experimental studies in human subjects. Sports Med. 2010 Sep 1;40(9):765-801. doi: 10.2165/11534530-000000000-00000. — View Citation

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Nilsson J, Ekblom O, Ekblom M, Lebedev A, Tarassova O, Moberg M, Lovden M. Acute increases in brain-derived neurotrophic factor in plasma following physical exercise relates to subsequent learning in older adults. Sci Rep. 2020 Mar 10;10(1):4395. doi: 10.1038/s41598-020-60124-0. — View Citation

Rasmussen P, Brassard P, Adser H, Pedersen MV, Leick L, Hart E, Secher NH, Pedersen BK, Pilegaard H. Evidence for a release of brain-derived neurotrophic factor from the brain during exercise. Exp Physiol. 2009 Oct;94(10):1062-9. doi: 10.1113/expphysiol.2009.048512. Epub 2009 Aug 7. — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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