Intermittent Hypoxia Paired With High Intensity Training in Brain Injury
关键词
抽象
描述
Our central hypotheses are that HIT combined with AIH results in: 1) greater locomotor gains as compared to HIT alone; 2) improvements in gait quality and motor coordination during walking, and 3) changes in measures of community participation and integration. To test these hypotheses, the proposed crossover, assessor-blinded, randomized clinical trial (RCT) is designed to test the effects of safety, feasibility, and preliminary efficacy of HIT+AIH. In this phase I-II trial, patients >6 months post-BI with mobility deficits will be allocated to 5 weeks (15 sessions) of HIT+AIH or HIT alone. Blinded assessments will be performed prior to and following training paradigms to address 3 specific aims.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 07/12/2020 |
| 提交的预估入学人数: | 07/12/2020 |
| 首次发布: | 07/14/2020 |
| 上次提交的更新: | 07/12/2020 |
| 最近更新发布: | 07/14/2020 |
| 实际学习开始日期: | 07/31/2020 |
| 预计主要完成日期: | 06/29/2023 |
| 预计完成日期: | 06/29/2024 |
状况或疾病
干预/治疗
Procedure: High Intensity Training with Intermittent Hypoxia
Procedure: High Intensity Training with Sham Hypoxia
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: High Intensity Training with Intermittent Hypoxia The primary goal will be provide acute intermittent hypoxia (9% PO2; 1 min on 1 min off) prior to stepping training while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing. | Procedure: High Intensity Training with Intermittent Hypoxia Acute intermittent treatment (AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. AIH (using 9% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented.
High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr). |
| Sham Comparator: High Intensity Training with Sham Hypoxia The primary goal will be provide sham intermittent hypoxia (20% PO2) prior to performing continuous stepping while maintaining HR within 70-85% maximum predicted HR (if patients are deconditioned, PTs will gradually increase intensity to desired levels as tolerated). Sessions will be divided into ~10 minute increments (~25% of sessions) between speed-dependent treadmill training (described above for treadmill stepping), skill-dependent treadmill training, overground training, and stair climbing. | Procedure: High Intensity Training with Sham Hypoxia Sham acute intermittent treatment (sham AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. Sham AIH (using 20% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented.
High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - > 6 months post traumatic brain injury - 18-75 years old - ability to walk without physical assistance - Self selected walking speed of 0.01-1.0 m/s Exclusion Criteria: - <18 years old - ->75 years old - self selected walking speed of > 1.0 m/s - < 3 months from botulinum toxin injection above the knee brace - Currently receiving physical therapy |
结果
主要结果指标
1. Change in gait speed [Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks]
2. Change in Endurance [Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks]
次要成果指标
1. Metabolic capacity [Baseline 1, Post 1 after 6 weeks, Baseline 2, Post 2 after 6 weeks]
