Ischemic StrokeNCT05735405
Aerobic Exercise and Cognitive Training in Patients With Stroke
A study testing Neuropsychological evaluation, BDNF evaluation and Pedaling as a moderate intensity aerobic exercise in people with Ischemic Stroke and Hemorrhagic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- Neuropsychological evaluation, BDNF evaluation and Pedaling as a moderate intensity aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Centro Ettore Spalenza- Fondazione Don Gnocchi
Rovato, Brescia, 25038
Alessandra Redolfi, +039 030/7245419, aredolfi@dongnocchi.it
Valentina Beccati, vbeccati@dongnocchi.it
About this study
Official title: Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke
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:
Read more
- Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
- 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.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Neuropsychological evaluation, BDNF evaluation, Pedaling as a moderate intensity aerobic exercise, Cognitive Training, VO2 assessment
- Keywords
- BDNF, Aerobic Exercise, Cognitive Training
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluationBehavioural
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.
BDNF evaluationBiological
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 exerciseBehavioural
During each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity.
Cognitive TrainingOther
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 assessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Neuropsychological evaluation; Biological: BDNF evaluation; Behavioral: Pedaling as a moderate intensity aerobic exercise; Other: Cognitive Training; Diagnostic Test: VO2 assessment |
| 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. Receives: Behavioral: Neuropsychological evaluation; Biological: BDNF evaluation; Behavioral: Pedaling as a moderate intensity aerobic exercise; Other: Cognitive Training; Diagnostic Test: VO2 assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in the neuropsychological test scores at 1 month
Secondary outcomes (1)
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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start12 Nov 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735405
- Sponsor's protocol ID
- Version 1; 01/09/22
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27144465Abraham 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.
PubMed 8658594Bathina 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.
PubMed 26788077Bediz 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.
PubMed 27148022Borror 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.
PubMed 28818262Chang 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.
PubMed 22480735Chmura 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.
PubMed 8063464Ferris 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.
PubMed 17414812Hennigan 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.
PubMed 17371291Hwang 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.
PubMed 27450438Knaepen 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.
PubMed 20726622Lambourne 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.
PubMed 20381468Nilsson 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.
PubMed 32157099Rasmussen 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.
PubMed 19666694Shobeiri 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.
PubMed 35239684
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Effects of Aerobic Exercise on Cognitive Training of Patients With Ischemic and Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT05735405
- Acronym / sponsor ID
- Version 1; 01/09/22
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- BDNF, Aerobic Exercise, Cognitive Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a moderate intensity aerobic exercise, prior to a cognitive training, allow a better performance?
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Neuropsychological evaluation, Biological: BDNF evaluation, Behavioral: Pedaling as a moderate intensity aerobic exercise, Other: Cognitive Training, Diagnostic Test: VO2 assessmentThe 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 | Behavioral: Neuropsychological evaluation, Biological: BDNF evaluation, Behavioral: Pedaling as a moderate intensity aerobic exercise, Other: Cognitive Training, Diagnostic Test: VO2 assessmentThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological evaluationEach 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. | Behavioural | Control Group, Experimental Group |
| BDNF evaluationDuring 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). | Biological | Control Group, Experimental Group |
| Pedaling as a moderate intensity aerobic exerciseDuring each session, each participant will perform 30 minutes of pedaling as a form of moderate intensity physical activity. | Behavioural | Control Group, Experimental Group |
| Cognitive TrainingDuring each session, each participant will carry out 60 minutes of cognitive training through specific exercises for the attentional, executive and working memory functions. | Other | Control Group, Experimental Group |
| VO2 assessmentTo 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. | Diagnostic test | Control Group, Experimental Group |
Primary outcome
Neuropsychological test scores
Time frame: 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.
1 secondary outcome
Number of errors committed in the cognitive exercises
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 27144465Faulkner 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.
- Background: PubMed 8658594Abraham 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.
- Background: PubMed 26788077Bathina 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.
- Background: PubMed 27148022Bediz 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.
- Background: PubMed 28818262Borror 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.
- Background: PubMed 22480735Chang 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.
- Background: PubMed 8063464Chmura 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.
- Background: PubMed 17414812Ferris 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.
- Background: PubMed 17371291Hennigan 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.
- Background: PubMed 27450438Hwang 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.
- Background: PubMed 20726622Knaepen 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.
- Background: PubMed 20381468Lambourne 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological evaluation, BDNF evaluation and Pedaling as a moderate intensity aerobic exercise in people with Ischemic Stroke and Hemorrhagic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological test scores (time frame: Change in the neuropsychological test scores at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735405, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.