Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877444
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2021-04-26
Brief Title:
Exercise Primed Stroke Rehabilitation
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Priming the Rehabilitation Engine Aerobic Exercise as the Fuel to Spark Behavioral Improvements in Stroke
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Stroke is a leading cause of disability in the US and many Veteran stroke survivors live with severe disability Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced physical and cognitive function and depression Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors Aerobic exercise AEx can improve physical and cognitive function and reduce depression Additionally AEx may enhance physical rehabilitation by making the brain more receptive to and consequently improving the response to an intervention Therefore combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors
Detailed Description:
The purpose of this project is to examine the priming effect of aerobic exercise AEx on a motor rehabilitation intervention for chronic stroke survivors Aerobic exercise AEx promotes numerous functional cognitive and psychological benefits For example AEx has demonstrated positive effects on physical performance cardiovascular health global cognition executive function and depressive symptoms in neurologically healthy individuals as well as survivors of stroke Importantly emerging evidence also supports the use of AEx as a priming tool to enhance motor outcomes following targeted rehabilitation Potential mechanisms underlying the priming effects of AEx include increases in circulating brain-derived neurotrophic factor BDNF and corticomotor excitability CME The wide-ranging behavioral and physiological benefits of AEx ideally suit it to serve as an adjunctive primer to stroke rehabilitation programs The investigators conceptual framework involves priming with AEx prior to targeted motor rehabilitation to enhance the neuroplastic environment and make the brain more amenable to adaptation thereby enhancing response to rehabilitation Specifically the investigators propose to pair AEx with an upper extremity virtual reality rehabilitation game called Duck Duck Punch DDP as the platform for examining the adjunctive potential of AEx To evaluate the priming effects of AEx chronic stroke survivors will be randomly assigned to receive 8 weeks 3 sessionsweek of DDP preceded by either 15 minutes of AEx AExDDP or a stretching control CONDDP This design will address the following specific aims
Aim 1 Evaluate the priming effects of AEx on a motor rehabilitation intervention for chronic stroke survivors
Aim 2 Quantify the effects of AEx priming on biomarkers of neuroplasticity
By stimulating the neuroplastic environment the investigators aim to enhance the response to motor rehabilitation However additional stroke sequelae eg cognitive and psychological function may influence the magnitude of change in motor function Depression and impaired cognitive function can negatively influence stroke recovery outcomes and are characterized by reduced neuroplastic potential and BDNF Subsequently subjects with depression or cognitive impairment are often excluded from rehabilitation trials Thus data that describes the relationship of multiple domains of stroke recovery as well as the neurobiological underpinnings of the response to rehabilitation will illuminate this gap in the literature and generate the formation of new hypotheses for future study
Exploratory Aim Examine the influence of cognitive and psychological function on motor response to AExDDP
The primary goal of this proposal is to provide foundational support to develop AEx as an adjunctive primer to rehabilitation The data generated will inform the development of additional AEx-based interventions for individuals following stroke as well as other neurological or neuropsychiatric conditions
Aim 1 Evaluate the priming effects of AEx on a motor rehabilitation intervention for chronic stroke survivors
Aim 2 Quantify the effects of AEx priming on biomarkers of neuroplasticity
By stimulating the neuroplastic environment the investigators aim to enhance the response to motor rehabilitation However additional stroke sequelae eg cognitive and psychological function may influence the magnitude of change in motor function Depression and impaired cognitive function can negatively influence stroke recovery outcomes and are characterized by reduced neuroplastic potential and BDNF Subsequently subjects with depression or cognitive impairment are often excluded from rehabilitation trials Thus data that describes the relationship of multiple domains of stroke recovery as well as the neurobiological underpinnings of the response to rehabilitation will illuminate this gap in the literature and generate the formation of new hypotheses for future study
Exploratory Aim Examine the influence of cognitive and psychological function on motor response to AExDDP
The primary goal of this proposal is to provide foundational support to develop AEx as an adjunctive primer to rehabilitation The data generated will inform the development of additional AEx-based interventions for individuals following stroke as well as other neurological or neuropsychiatric conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None