Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701815
Status:
UNKNOWN
Last Update Posted:
2018-10-10
First Post:
2018-09-27
Brief Title:
Effect of Lifestyle Changes on BDNF Level After Stroke
Sponsor:
VA Palo Alto Health Care System
Organization:
VA Palo Alto Health Care System
Study Overview
Official Title:
Assessing the Effect of Multi-disciplinary Lifestyle Medicine Intervention on Brain-derived Neurotrophic Factor Levels Following Stroke
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
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 is a pilot study to determine whether a lifestyle medicine intervention following stroke may increase levels of Brain-Derived Neurotrophic Factor BDNF
Detailed Description:
This is a substudy of the study entitled Assessing a Multi-Disciplinary Lifestyle Medicine Intervention Following Stroke specifically looking at the effects of lifestyle change on brain-derived neurotrophic factor BDNF BDNF has emerged as a key facilitator of neuroplasticity to improve motor learning and rehabilitation after stroke Aerobic exercise has been shown to increase levels of BDNF in multiple parts of the central nervous system and therefore may facilitate neuroplasticity and motor recovery While BDNF levels appear to be increased for up to 1 hour following a bout of aerobic exercise it is unclear whether regular aerobic exercise over weeks to months can increase baseline BDNF levels in humans following stroke
An single nucleotide polymorphism exists on the BDNF gene in 30-50 of the human population that results in an amino acid change from valine val to methionine met at position 66 val66met of the precursor peptide proBDNF The presence of the met allele results in a 25 reduction in activity-dependent secretion of BDNF in the CNS
The Wellness in Rehabilitation program at the VA Palo Alto Health Care System is a lifestyle medicine intervention for patients following stroke It is a 12-week program involving weekly meetings that include exercise particularly aerobic exercise nutrition stress management education and group support Participants are encouraged to perform healthy lifestyle behaviors ie exercise daily at home and a health coach calls each patient weekly to support the behavior change process
Participants in the Wellness in Rehabilitation program who elect to participate in the research study will have blood drawn at baseline week 6 and week 12 Blood draws will be performed in the morning prior to exercise and week 6 will additionally include a blood draw within 30 minutes of completing a bout of aerobic exercise Following completion of the study plasma BDNF levels measured as nanograms per milliliter will then be measured at all 4 time points baseline week 6 pre-exercise week 6 post-exercise and week 12 In addition BDNF genotype will be measured using the baseline sample Participants will also complete bike or treadmill exercise testing at baseline and week 12 to determine pre- and post-program cardiovascular fitness levels measured as VO2 max and estimated metabolic equivalents and will also complete a 6-minute walk test They will be asked to record their exercise daily and will additionally complete the Physical Activity Scale for Individuals with Physical Disabilities at baseline and week 12 time points
An single nucleotide polymorphism exists on the BDNF gene in 30-50 of the human population that results in an amino acid change from valine val to methionine met at position 66 val66met of the precursor peptide proBDNF The presence of the met allele results in a 25 reduction in activity-dependent secretion of BDNF in the CNS
The Wellness in Rehabilitation program at the VA Palo Alto Health Care System is a lifestyle medicine intervention for patients following stroke It is a 12-week program involving weekly meetings that include exercise particularly aerobic exercise nutrition stress management education and group support Participants are encouraged to perform healthy lifestyle behaviors ie exercise daily at home and a health coach calls each patient weekly to support the behavior change process
Participants in the Wellness in Rehabilitation program who elect to participate in the research study will have blood drawn at baseline week 6 and week 12 Blood draws will be performed in the morning prior to exercise and week 6 will additionally include a blood draw within 30 minutes of completing a bout of aerobic exercise Following completion of the study plasma BDNF levels measured as nanograms per milliliter will then be measured at all 4 time points baseline week 6 pre-exercise week 6 post-exercise and week 12 In addition BDNF genotype will be measured using the baseline sample Participants will also complete bike or treadmill exercise testing at baseline and week 12 to determine pre- and post-program cardiovascular fitness levels measured as VO2 max and estimated metabolic equivalents and will also complete a 6-minute walk test They will be asked to record their exercise daily and will additionally complete the Physical Activity Scale for Individuals with Physical Disabilities at baseline and week 12 time points
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