Pilot Trial for Adults With Acquired Brain Injury

NCT ID: NCT05793827

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-11-17

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.

Conditions

Acquired Brain Injury; Traumatic Brain Injury; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Adapted Hatha Yoga

Group Type: EXPERIMENTAL

Adapted Hatha Yoga

Intervention Type: BEHAVIORAL

Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation

Low-Impact Exercise

Group Type: ACTIVE_COMPARATOR

Low-Impact Exercise

Intervention Type: BEHAVIORAL

This includes low-intensity exercise, which is matched to the estimated metabolic costs of yoga, 2.5 Metabolic Equivalent of Task (MET). Sessions include warm up, cool down, and five, 10-minute exercise stations, (e.g., walking, balance, resistance bands, weight-bearing exercise, and core work). Control exercise will be prescribed between 2.0 to 3.0 METs, equating to 30 to 40% heart rate reserve. Heart rate zones are calculated for each participant and monitored to ensure proper intensity

Interventions

Adapted Hatha Yoga

Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation

Intervention Type: BEHAVIORAL

Low-Impact Exercise

This includes low-intensity exercise, which is matched to the estimated metabolic costs of yoga, 2.5 Metabolic Equivalent of Task (MET). Sessions include warm up, cool down, and five, 10-minute exercise stations, (e.g., walking, balance, resistance bands, weight-bearing exercise, and core work). Control exercise will be prescribed between 2.0 to 3.0 METs, equating to 30 to 40% heart rate reserve. Heart rate zones are calculated for each participant and monitored to ensure proper intensity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boettcher Webb-Waring Biomedical Research Awards

UNKNOWN

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaclyn Stephens, PhD, OTR

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Translational Medicine Institute

Fort Collins, Colorado, United States

Countries

United States

References

Stephens JA, Hernandez-Sarabia JA, Sharp JL, Leach HJ, Bell C, Thomas ML, Buryznska AZ, Weaver JA, Schmid AA. Adaptive yoga versus low-impact exercise for adults with chronic acquired brain injury: a pilot randomized control trial protocol. Front Hum Neurosci. 2023 Nov 23;17:1291094. doi: 10.3389/fnhum.2023.1291094. eCollection 2023.

Reference Type: DERIVED

PMID: 38077184 (View on PubMed)

Other Identifiers

1799

Identifier Type: -

Identifier Source: org_study_id