Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Stroke
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study participants will be randomized to one of two groups. One group will receive 24 sessions of aerobic exercise and upper extremity rehabilitation. The second group will receive 24 sessions of stretching exercise and upper extremity rehabilitation.Masking: Single (Outcomes Assessor)Masking Description: The primary outcome measure will be assessed by a blinded rater to improve scientific rigor.Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 90 years
Gender
Both males and females

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...

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 sessions/week) of DDP preceded by either 15 minutes of AEx (AEx+DDP) or a stretching control (CON+DDP). 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 AEx+DDP. 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.

Tracking Information

NCT #
NCT04877444
Collaborators
Not Provided
Investigators
Principal Investigator: Ryan E Ross, PhD Ralph H. Johnson VA Medical Center, Charleston, SC