Respiratory Motor Control and Blood Pressure Regulation After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in Pulmonary Function Test outcomes
研究概览
简要总结
The proposed study is designed to answer a novel research question: Can resistive respiratory muscle training designed to improve respiratory motor control also improve blood pressure regulation impaired by spinal cord injury? Resistive breathing exercise, or respiratory muscle training, has been applied to rehabilitate breathing after spinal cord injury, but has not been evaluated as a method for increasing resting blood pressure and / or improving its regulation under stress as is planned in the proposed project. For the first time, respiratory muscle training intervention will be used as a tool to investigate the physiological relationships between pulmonary and cardiovascular function in individuals with Spinal Cord Injury (SCI). Thus, it will foster a new direction from which to address neglected issues surrounding the cardiovascular complications of spinal cord injury.
详细描述
Screening:
To aid in determining eligibility, participants will have a respiratory and cardiovascular function tests. The participants will also have an ASIA (American Spinal Injury Association) exam to grade the degree and level of their SCI.
Enrollment:
Following screening process, consenting and recruiting, the experimental recordings:
- Pulmonary Function Test- This test measures lung volumes, airflow and airway pressure with standard equipment;
- Respiratory Motor Control Assessment- Pulmonary function test is repeated while participant is sitting in a special hospital bed and lying on their back while the investigators record electrical impulses from their neck, chest, arms, legs, abdomen and back muscles. These impulses record how their muscles are contracting. The investigators also record how their chest and abdomen are moving by placing elastic belts around their chest and abdomen. Blood pressure will be measured using a finger cuff;
- Orthostatic stress test- Using the same methods as above, the investigators will measure blood pressure, heart rate and chest and abdomen movements while the participant is lying down on their back and when the position is suddenly changed to sitting in the investigators' cardiac chair or to upright vertical position on a Tilt table. The investigators will measure blood samples at several intervals from a small catheter inserted into the vein in the arm.
- Ultrasound of the heart will be performed before and after the Respiratory Muscle Training (RMT) program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old;
- •stable medical condition without diseases or autonomic dysreflexia that would contraindicate RMT;
- •no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with RMT;
- •no clinically significant depression, psychiatric disorders or ongoing drug abuse;
- •clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms;
- •no current anti-spasticity medication regimen;
- •non-progressive C3-T5 American Spinal Cord Injury Association Designation of A-D SCI;
- •not ventilator dependent for respiration;
- •sustained SCI at least 6 months prior to entering the study;
- •at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) detected by screening spirometry; and
- •orthostatic hypotension (the decrease 20mm Hg or more in systolic or a reduction 10mm Hg or more in diastolic blood pressure on changing body position from a supine to an upright) detected by screening orthostatic stress test
排除标准
- •a presence of major cardiovascular or pulmonary disease, endocrine disorders, malignancy, marked obesity, deep vein thrombosis, and major gastrointestinal problem such as swallowing or other major medical illness contraindicated for respiratory muscle training or testing.
- •Pregnant women are excluded from this study, as the risk to the fetus is unknown. No pregnancy test or birth control regimen will be required.
研究组 & 干预措施
Control
Following screening process and recruiting, subjects from both Healthy Control and SCI Control groups will undergo the same procedures as subjects from SCI group excluding the training intervention.
Respiratory Muscle Training
Each training session will last about 45-60 min and will occur five times weekly during one month. During the RMT sessions, the patient will remain in their personal wheelchair. They will be asked to breath through a special device with regulated resistance to breathing air. In the 20 sessions starting from the lowest resistance, the goal will be to train the muscles they use to breathe by slowly increasing this resistance. They will perform six work sets, 5 minutes in duration, separated by rest intervals lasting 1-3 minutes.
干预措施: Respiratory Muscle Training (Behavioral)
结局指标
主要结局
Changes in Pulmonary Function Test outcomes
时间窗: At baseline, after 1-month long respiratory training, and during 6 months of follow-up period
Lung volumes, capacities, air flow, and airway pressure assessed using standard spirometry and maximum airway pressure recordings.
次要结局
- Changes in Respiratory Motor Control Assessment outcomes(At baseline, after 1-month long respiratory training, and during 6 months of follow-up period)
- Changes in Orthostatic Stress Test outcomes(At baseline, after 1-month long respiratory training, and during 6 months of follow-up period)
- Changes in cardiac output(At baseline, after 1-month long respiratory training, and during 6 months of follow-up period)
研究者
Alexander V Ovechkin, MD, PhD
Associate Professor
University of Louisville