Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05076747
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2021-09-21
Brief Title:
Exercise and Genotype in Sub-acute Stroke
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Promoting Brain Plasticity During Sub-acute Stroke The Interactive Role of Exercise and Genotype
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate the impact of cardiovascular exercise on brain plasticity among patients in sub-acute stages after stroke and whether genotype modulates the response to this intervention Participants in the experimental group will perform cardiovascular training for 8 weeks three timesweek in addition to standard therapy while participants in the control group will perform standard therapy only Assessments will be performed at baseline four weeks and 8 weeks after training
Detailed Description:
Background Research has shown that the adult human brain has an enormous plastic capacity to adapt after injury In people who have recently experienced a stroke interventions that promote brain plasticity in early stages after stroke can improve long-term recovery Cardiovascular exercise is a simple strategy to increase brain plasticity and promote neural reorganization However there is no information about the effects of cardiovascular exercise on brain plasticity in early phases of stroke despite the importance of this initial period for long-term recovery Similarly it is not known if depending on their genetic profile some people will be more responsive than others to this type of exercise
Objectives To establish whether 1 cardiovascular exercise improves brain plasticity during the initial phases of post-stroke recovery 2 carrying a specific form of the BDNF gene modulates the response to cardiovascular exercise
Design 70 participants will perform either a progressive high-intensity cardiovascular exercise program or low-intensity stretching and toning exercise program Both groups will undergo 8 weeks of training performed 3 times per week Assessments will be performed at the beginning mid-point 4 weeks and at the end of the training period 8 weeks
Methodology Assessments 1 brain plasticity by measuring changes in brain excitability a marker of brain plasticity with non-invasive brain stimulation 2 BDNF levels by measuring the blood concentration of this protein 3 Genotype by identifying the subtype of BDNF gene carried by each participant 4 Cardiorespiratory fitness by assessing the performance during a graded exercise test
Statistical analysis Differences between exercise and control groups on the primary endpoint of all outcomes will be analyzed with linear mixed models Besides baseline scores sex age and type of stroke cortical or subcortical will be included as covariates because they can affect brain plasticity and BDNF response T1 scores will also be included to increase the efficiency of the model The influence of genotype on changes in primary and secondary outcomes in the exercise group will be inspected with the Freedman-Schatzkin test a powerful technique to identify mediators of change that can be used in small-scale exercise studies
Expected outcomes Cardiovascular exercise will promote positive changes in brain excitability and will increase blood BDNF levels in individuals in the early phases of stroke recovery However the individual response to this type of exercise in relation to brain plasticity and BDNF levels will be influenced by the genotype of each participant
Relevance It is important to establish whether cardiovascular exercise enhances brain reorganization early after stroke post-stroke and whether genetic factors may influence the response to this intervention This will provide clinicians with useful information which will be essential to design more individualized exercise-based treatments to optimize functional recovery in individuals with stroke
Impact The first weeks after a stroke are critical for functional recovery After this initial period the rate of recovery slows down and functional improvements become much more difficult to achieve In Canada health-care costs in the 6 months after stroke amount to 28 billionyear Finding cost-effective rehabilitation strategies to promote recovery during the early phases post-stroke is essential to help patients return to an independent living
Objectives To establish whether 1 cardiovascular exercise improves brain plasticity during the initial phases of post-stroke recovery 2 carrying a specific form of the BDNF gene modulates the response to cardiovascular exercise
Design 70 participants will perform either a progressive high-intensity cardiovascular exercise program or low-intensity stretching and toning exercise program Both groups will undergo 8 weeks of training performed 3 times per week Assessments will be performed at the beginning mid-point 4 weeks and at the end of the training period 8 weeks
Methodology Assessments 1 brain plasticity by measuring changes in brain excitability a marker of brain plasticity with non-invasive brain stimulation 2 BDNF levels by measuring the blood concentration of this protein 3 Genotype by identifying the subtype of BDNF gene carried by each participant 4 Cardiorespiratory fitness by assessing the performance during a graded exercise test
Statistical analysis Differences between exercise and control groups on the primary endpoint of all outcomes will be analyzed with linear mixed models Besides baseline scores sex age and type of stroke cortical or subcortical will be included as covariates because they can affect brain plasticity and BDNF response T1 scores will also be included to increase the efficiency of the model The influence of genotype on changes in primary and secondary outcomes in the exercise group will be inspected with the Freedman-Schatzkin test a powerful technique to identify mediators of change that can be used in small-scale exercise studies
Expected outcomes Cardiovascular exercise will promote positive changes in brain excitability and will increase blood BDNF levels in individuals in the early phases of stroke recovery However the individual response to this type of exercise in relation to brain plasticity and BDNF levels will be influenced by the genotype of each participant
Relevance It is important to establish whether cardiovascular exercise enhances brain reorganization early after stroke post-stroke and whether genetic factors may influence the response to this intervention This will provide clinicians with useful information which will be essential to design more individualized exercise-based treatments to optimize functional recovery in individuals with stroke
Impact The first weeks after a stroke are critical for functional recovery After this initial period the rate of recovery slows down and functional improvements become much more difficult to achieve In Canada health-care costs in the 6 months after stroke amount to 28 billionyear Finding cost-effective rehabilitation strategies to promote recovery during the early phases post-stroke is essential to help patients return to an independent living
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None