跳至主要内容
临床试验/NCT05793827
NCT05793827已完成不适用

Evaluating Yoga Intervention-Induced Changes in Performance and Neurophysiology in Adults With Chronic Brain Injury

Colorado State University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Change from Baseline in Standing Balance at 2 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The principal investigator and postdoctoral fellow are exclusively responsible for assessing outcomes and both are masked to participant group membership. The participants, interventionists, and other key persons are not masked to participant group membership, but they are not involved in any of the outcome assessments.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Change from Baseline in Standing Balance at 2 Months

时间窗: 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..

Acquired using a force plate during simultaneous functional near-infrared spectroscopy

Change from Baseline in Autonomic Nervous System Function at 2 Months

时间窗: 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.

Acquired via heart rate variability assessment using electrocardiography

Change from Baseline in Functional Connectivity of Neural Networks at 2 Months

时间窗: 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..

Acquired via resting state functional magnetic resonance imaging

Change from Baseline in Task-Dependent Neural Activation at 2 Months

时间窗: 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..

Acquired pre- and post-intervention via portable functional near-infrared spectroscopy during standing balance plates with force plate.

次要结局

  • Change from Baseline in Cognitive Flexibility at 2 Months(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.)
  • Change from Baseline in Self-Reported Quality of Life at 2 Months(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..)
  • Change from Baseline in Working Memory Performance at 2 Months(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. .)
  • Change from Baseline in Inhibitory Control at 2 Months(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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验