Acute Intermittent Hypoxia and Respiratory Strength Training to Improve Breathing Function After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in maximal expiratory pressure
研究概览
简要总结
Acute intermittent hypoxia (AIH) involves short (~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.
详细描述
Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing muscle paralysis and decreased breathing capacity. Since respiratory impairment is the major cause of illness and death with SCI, it is critical to devise new strategies to restore breathing function.
Repetitive exposure to brief episodes of low oxygen (acute intermittent hypoxia or AIH) has demonstrated to increase respiratory function in humans with chronic SCI. Additionally pre-clinical studies demonstrate that AIH-induced functional benefits are enhanced by combining AIH with task-specific training. The investigator's central hypothesis is that combined daily AIH (dAIH) and respiratory strength training will elicit greater and more sustained gains in respiratory function than either treatment alone in people with chronic SCI.
This study is a double-blind, randomized, cross-over design where participants will complete 4 random-ordered blocks, consisting of a 5-day intervention followed by a 3-week washout period, during which 1-day, 3-day, and 1-week post-tests will be conducted. Participants will include 53 adults with chronic, incomplete SCI with >20% respiratory impairment based on maximal inspiratory or expiratory pressure generation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants and the clinical evaluator will be informed of possible interventions but will be blinded to the gas mixture (hypoxic vs normoxic air) used during each AIH intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic incomplete SCI for ≥ 1 year at or below C-1 to T-12
- •Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI
- •Chronic complete SCI for ≥ 1 year at or below C-4 to T-12
- •Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.
- •Medically stable with clearance from physician
- •SCI due to non-progressive etiology
- •>20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values.
排除标准
- •Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
- •Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction, <1 year lung disease, infections, hypertension, heterotopic ossification.
- •Severe neuropathic pain
- •Known pregnancy
- •Severe recurrent autonomic dysreflexia
- •History of seizure disorder < 1 year
结局指标
主要结局
Change in maximal expiratory pressure
时间窗: Baseline, Day 1, Day 6, Day 8, Day 15
Maximal expiratory pressure is a non-invasive measure of the maximal force generated when breathing out against an occluded airway.
Change in maximal inspiratory pressure
时间窗: Baseline, Day 1, Day 6, Day 8, Day 15
Maximal inspiratory pressure is a non-invasive measure of the maximal force achieved when breathing in against an occluded airway.
次要结局
未报告次要终点