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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Control Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological evaluation | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Ettore Spalenza- Fondazione Don Gnocchi | Recruiting | Rovato | Brescia | 25038 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27144465 | Background | 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. | |
| 8658594 | Background | 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. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| BDNF evaluation | Biological | 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). |
|
| Pedaling as a moderate intensity aerobic exercise | Behavioral | During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity. |
|
| Cognitive Training | Other | During each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions. |
|
| VO2 assessment | Diagnostic Test | 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. |
|
| 26788077 | Background | 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. |
| 27148022 | Background | 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. |
| 28818262 | Background | 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. |
| 22480735 | Background | 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. |
| 8063464 | Background | 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. |
| 17414812 | Background | 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. |
| 17371291 | Background | 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. |
| 27450438 | Background | 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. |
| 20726622 | Background | 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. |
| 20381468 | Background | 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. |
| 32157099 | Background | 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. |
| 19666694 | Background | 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. |
| 35239684 | Background | 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. |
| 20223924 | Background | 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. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |