Respiratory Muscle Training to Improve Functional Capacity and Prevent Respiratory Complications in Adults With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in maximal expiratory pressure
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of a programme based on inspiratory and expiratory muscle training to improve respiratory muscle strength, functional capacity and avoid pulmonary complications in adults with cervical or high dorsal spinal cord injury (C5-D5) in acute phase.
详细描述
The design of the study is a randomised, triple-blind clinical trial with a control group.
The size of the sample will be 56 participants with cervical spinal cord injury and 56 with dorsal spinal cord injury. They will be randomized in two groups: experimental or control. The experimental group will perform combined inspiratory and expiratory muscle training as part of their rehabilitation programme during 6 weeks. The control group will continue their usual treatment.
Measurements will be taken at baseline, and post-intervention.
The statistical analysis will be an intention-to-treat analysis, and the data processing and analysis will be carried out with the Statistical Package for the Social Sciences (SPSS) version 24.0 for Windows (Armonk, NY: IBM Corp.).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Masking of the researchers: randomisation of the sample will be performed using STATA software by a member of the research team who will not be involved in patient recruitment or data collection. The interventions will be carried out by researchers different from those who will perform the evaluation of the outcomes.
Masking of the participants: the control group will have a training of the respiratory muscles simulated with the same device as the intervention group. They will use the device without load and with an opaque adhesive tape surrounding the device to mask the valve position.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People diagnosed with spinal cord injury.
- •Over 18 years of age.
- •Time of evolution less than 6 months and at least 4 weeks after the date of injury.
- •Level of lesion between C5 and D5 and degree of involvement A or B. In case of involvement A with partial preservation zone this should not include abdominal musculature according to the international standardised classification of the American Spinal Injury Association.
排除标准
- •People with chest trauma.
- •Mechanically ventilated.
- •Pregnant women.
- •Any medical or psychiatric condition that could affect the ability to complete the study.
- •Carrying a tracheostomy tube that does not tolerate occlusion.
- •People who can not sit upright.
结局指标
主要结局
Change in maximal expiratory pressure
时间窗: Change after 6 weeks of intervention compared to baseline
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
Change in maximal inspiratory pressure
时间窗: Change after 6 weeks of intervention compared to baseline
The measurement of maximum static respiratory pressures will consist of performing maximum forced inspiration and expiration manoeuvres against an occluded airway in order to measure the pressure generated in the mouth, using a manometer or a pressure transducer, since, with the glottis open, the pressure in the mouth must be equal to the alveolar pressure.
次要结局
- Change in shoulder flexion strength(Change after 6 weeks of intervention compared to baseline)
- Change in coughing capacity(Change after 6 weeks of intervention compared to baseline)
- Change in number of people with respiratory complications(Change after 6 weeks of intervention compared to baseline)
- Change in forced expiratory volume in the first second (FEV1)(Change after 6 weeks of intervention compared to baseline)
- Change in elbow flexion strength(Change after 6 weeks of intervention compared to baseline)
- Change in forced vital capacity (FVC)(Change after 6 weeks of intervention compared to baseline)
- Change in health-related quality of life assessed by Short-Form 36 questionnaire.(Change after 6 weeks of intervention compared to baseline)
- Change in cardiorespiratory fitness(Change after 6 weeks of intervention compared to baseline)