Ischemic Stroke Clinical Trial
Official title:
Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke
Verified date | October 2022 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Centro Ettore Spalenza- Fondazione Don Gnocchi | Rovato | Brescia |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus |
Italy,
Abraham WC, Bear MF. Metaplasticity: the plasticity of synaptic plasticity. Trends Neurosci. 1996 Apr;19(4):126-30. doi: 10.1016/s0166-2236(96)80018-x. — View Citation
Bathina S, Das UN. Brain-derived neurotrophic factor and its clinical implications. Arch Med Sci. 2015 Dec 10;11(6):1164-78. doi: 10.5114/aoms.2015.56342. Epub 2015 Dec 11. — View Citation
Bediz CS, Oniz A, Guducu C, Ural Demirci E, Ogut H, Gunay E, Cetinkaya C, Ozgoren M. Acute Supramaximal Exercise Increases the Brain Oxygenation in Relation to Cognitive Workload. Front Hum Neurosci. 2016 Apr 20;10:174. doi: 10.3389/fnhum.2016.00174. eCollection 2016. — View Citation
Borror A. Brain-derived neurotrophic factor mediates cognitive improvements following acute exercise. Med Hypotheses. 2017 Sep;106:1-5. doi: 10.1016/j.mehy.2017.06.024. Epub 2017 Jun 29. — View Citation
Chang YK, Labban JD, Gapin JI, Etnier JL. The effects of acute exercise on cognitive performance: a meta-analysis. Brain Res. 2012 May 9;1453:87-101. doi: 10.1016/j.brainres.2012.02.068. Epub 2012 Mar 4. Erratum In: Brain Res. 2012 Aug 27;1470:159. — View Citation
Chmura J, Nazar K, Kaciuba-Uscilko H. Choice reaction time during graded exercise in relation to blood lactate and plasma catecholamine thresholds. Int J Sports Med. 1994 May;15(4):172-6. doi: 10.1055/s-2007-1021042. — View Citation
Faulkner J, Lambrick D, Kaufmann S, Stoner L. Effects of Upright and Recumbent Cycling on Executive Function and Prefrontal Cortex Oxygenation in Young Healthy Men. J Phys Act Health. 2016 Aug;13(8):882-7. doi: 10.1123/jpah.2015-0454. Epub 2016 May 4. — View Citation
Ferris LT, Williams JS, Shen CL. The effect of acute exercise on serum brain-derived neurotrophic factor levels and cognitive function. Med Sci Sports Exerc. 2007 Apr;39(4):728-34. doi: 10.1249/mss.0b013e31802f04c7. — View Citation
Hennigan A, O'Callaghan RM, Kelly AM. Neurotrophins and their receptors: roles in plasticity, neurodegeneration and neuroprotection. Biochem Soc Trans. 2007 Apr;35(Pt 2):424-7. doi: 10.1042/BST0350424. — View Citation
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
Lambourne K, Tomporowski P. The effect of exercise-induced arousal on cognitive task performance: a meta-regression analysis. Brain Res. 2010 Jun 23;1341:12-24. doi: 10.1016/j.brainres.2010.03.091. Epub 2010 Apr 8. — View Citation
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
Shobeiri P, Karimi A, Momtazmanesh S, Teixeira AL, Teunissen CE, van Wegen EEH, Hirsch MA, Yekaninejad MS, Rezaei N. Exercise-induced increase in blood-based brain-derived neurotrophic factor (BDNF) in people with multiple sclerosis: A systematic review and meta-analysis of exercise intervention trials. PLoS One. 2022 Mar 3;17(3):e0264557. doi: 10.1371/journal.pone.0264557. eCollection 2022. — View Citation
Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11. — View Citation
* Note: There are 16 references in all — Click here to view all references
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 |
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