Clinical trial NCT05793827: Pilot Trial for Adults With Acquired Brain Injury
Official title: Evaluating Yoga Intervention-Induced Changes in Performance and Neurophysiology in Adults With Chronic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Traumatic Brain Injury
Stroke
Keywords: Yoga
Exercise
Balance
Autonomic Nervous System
Functional Near-Infrared Spectroscopy
Functional Magnetic Resonance Imaging
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Boettcher Webb-Waring Biomedical Research Awards
First posted: 2023-03-31
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. The investigators also plan to measure changes in brain function and link balance and/or heartrate improvements to changes in brain function. Ideally, this work will create a foundation for a larger-scale study.

Detailed description: Background and Significance: Each year, an estimated 2.9 million Americans sustain brain injuries that result in emergency department visits, hospitalizations, and death. Although there are many treatment strategies in the early weeks and months after brain injury, millions of individuals live with residual disability. This residual, chronic disability often includes significant impairments and decreased brain function. Two prominent and interconnected impairments - poor balance and autonomic nervous system (ANS) dysfunction - can increase fall risk, decrease quality of life, and increase mortality. In adults with brain injury, ANS dysfunction is characterized by hyper-activation of the sympathetic nervous system, which can have damaging or even fatal impact on internal organs. To date, there are exceedingly few options for addressing these types of impairments or improving brain function in adults with chronic brain injury. However, community-based and holistic interventions, like hatha yoga, may be highly effective for simultaneously addressing balance and ANS impairments and may also improve brain function. Hatha yoga incorporates movements that improve balance, uses breathwork that may stabilize sympathetic and parasympathetic nervous system activity, can be adapted for individual needs, and has enhanced brain function in healthy adults. Despite this, there are few empirical studies investigating yoga for individuals with brain injury. To resolve this, the research team and investigator have conducted two yoga and brain injury feasibility studies and confirmed that recruitment, retainment, intervention, and neuroimaging procedures are feasible. In these studies, the investigators have found significant improvements in balance after yoga and preliminary evidence of improved brain function, even in the absence of measurable balance improvement. Finally, there is growing evidence that exercises, like yoga, can improve ANS function by regulating sympathetic and parasympathetic activity in healthy adults, suggesting significant potential for adults with chronic brain injury.

Project Objectives: Given feasibility study success and promising early findings. The investigators will conduct a pilot randomized control trial comparing 8-weeks of group yoga to 8-weeks of active control exercise in 48 adults with chronic brain injury. The investigators will test for improvements in balance and in ANS function using heart-rate variability (HRV) monitoring. The investigator will explore intervention-induced changes in brain function by evaluating intrinsic functional connectivity, using resting-state functional magnetic resonance imaging (rs-fMRI) and task-dependent neural activation, using a proxy of neural activity - oxygenated hemoglobin (HbO) - as measured with functional near-infrared spectroscopy (fNIRS) during concurrent balance tasks. Finally, if the investigators observe functional improvements in balance or ANS function and measurable changes in brain function, the investigator will then complete exploratory analyses to link functional improvements to changes in brain function.

Eligibility criteria: Inclusion Criteria:

* Sustained acquired brain injury at least 6 months prior
* Self-reported balance impairment of moderate or greater, via the Neurobehavioral Symptom Inventory
* Standard fMRI safety screening for MRI components only (participants can complete other study components if they are ineligible or unwilling to complete MRI)

Exclusion Criteria:

* Sustained acquired brain injury within past 6 months
* Self-reported mild balance impairment or no balance impairment

Primary outcomes:
measure: Change from Baseline in Standing Balance at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months..
measure: Change from Baseline in Autonomic Nervous System Function at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
measure: Change from Baseline in Functional Connectivity of Neural Networks at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
measure: Change from Baseline in Task-Dependent Neural Activation at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
Secondary outcomes:
measure: Change from Baseline in Self-Reported Quality of Life at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..
measure: Change from Baseline in Working Memory Performance at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months. .
measure: Change from Baseline in Inhibitory Control at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
measure: Change from Baseline in Cognitive Flexibility at 2 Months
timeFrame: Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Translational Medicine Institute
state: Colorado
Study officials:
affiliation: Colorado State University
name: Jaclyn Stephens, PhD, OTR
role: PRINCIPAL_INVESTIGATOR
References: