Respiratory Muscle Training in Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Maximum respiratory pressures (PIM and PEM)
研究概览
简要总结
Spinal Cord Injury (SCI) is an involvement of the spinal cord, a nerve cord protected by the spine and extends from the base of the brain to the lumbar region. The spinal cord lesion causes complete or incomplete paralysis of voluntary mobility and absence, partial or total, of any sensitivity below the affected area; In addition, it also involves the lack of control over the sphincters of urination and intestinal evacuation, disorders of sexuality and fertility, alterations of the Vegetative Nervous System and risk of suffering other complications not less important as: bedsores, spasticity, kidney processes, ...
The cervical and dorsal cord injury severely affects respiratory function due to paralysis and deterioration of the respiratory muscles. Several types of respiratory muscle training (RMT) have been described to improve respiratory function for people with SCI in the literature.
Despite the relatively small number of studies included in this review, the meta-analysis of the pooled data indicates that RMT would be effective in increasing respiratory muscle strength and also lung volumes for people with SCI.
More research is needed to obtain functional results after EMR, such as dyspnea, cough efficacy, respiratory complications, hospital admissions due to respiratory complications and quality of life.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute spinal cord injury from C5 to T11 (AIS A-B)
- •No tracheotomy user or invasive mechanical ventilation.
- •Age between 18 years - 75 years.
排除标准
- •Not wanting to participate in the study.
- •Not meet inclusion criteria
- •Cognitive or psychiatric disorder that does not allow you to participate in the study.
结局指标
主要结局
Maximum respiratory pressures (PIM and PEM)
时间窗: Through study completion, an average of 1 year
Measured with respiratory pressure gauge Assessments: Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year.
Forced Spirometry (FVC).
时间窗: Through study completion, an average of 1 year
Measured with a spirometer It is the maximum volume of exhaled air, with the maximum possible effort, starting from a maximum inspiration. It is expressed as volume (in ml) and is considered normal when it is greater than 80% of its theoretical value. Assessments: Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year.
Peak expiratory Flow (PEF)
时间窗: Through study completion, an average of 1 year
Measured with a spirometer It is the Maximum Flow (Peak expiratory Flow Right--(PEF)) that can be generated during a forced expiration maneuver; Measurement in liters per second. Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year.
Peak Cough Flow (PCF).
时间窗: Through study completion, an average of 1 year
Measured with a peak cough flow meter Assessments: Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year.
次要结局
- Measurement of independence in spinal cord injury and respiratory function(Through study completion, an average of 1 year)
- Quality of life questionnaire (EQ-5D).(Through study completion, an average of 1 year)