RMT in Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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Respiratory Muscle Training in Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Experimental
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement. | Other: Experimental<br>* The study variables PIM, PEM, FVC, PEF and EQ-5D quality of life questionnaire will be measured on the first day when patient incorporated into the seating position in the patient's bed. Reassessments will be performed every two week till patient discharge from hospital. After that patient will be assessed after 4 month and 1 year after the SCI. SCIM III will be administered at discharge, 4 month later and 1 year after the injury. Common clinical practice (pulmonary expansion exercises,drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement. The intensity of the treatment will be 50% of the PIM and PEM value (increasing the load in 2 cmH2O weekly). Three sets of 10 reps will be performed, with one total of 30 repetitions, resting 1 minute between each series. The sessions will be held once per day, from monday to friday, during the entire hospital admission.<br>* Other names: High intensity training;|
| Active Comparator: Group 2<br>Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement. | Other: Control<br>* The study variables PIM, PEM, FVC, PEF and EQ-5D quality of life questionnaire will be measured on the first day when patient incorporated into the seating position in the patient's bed. Reassessments will be performed every two week till patient discharge from hospital. After that patient will be assessed after 4 month and 1 year after the SCI. SCIM III will be administered at discharge, 4 month later and 1 year after the injury. Common clinical practice (pulmonary expansion exercises,drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement. The intensity of the treatment will be 30% of the PIM value (increasing the load in 2 cmH2O weekly). Three sets of 10 reps will be performed, with one total of 30 repetitions, resting 1 minute between each series. The sessions will be held once per day, from monday to friday, during the entire hospital admission.<br>* Other names: Usual intensity training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum respiratory pressures (PIM and PEM) | Measured with respiratory pressure gauge Assessments: Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year. | Through study completion, an average of 1 year | 
| Peak Cough Flow (PCF). | 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. | Through study completion, an average of 1 year | 
| Forced Spirometry (FVC). | 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. | Through study completion, an average of 1 year | 
| Peak expiratory Flow (PEF) | 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. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of independence in spinal cord injury and respiratory function | Measured with SCIM III Test Assessments: Baseline, hospital discharge, after 4 month and after 1 year. | Through study completion, an average of 1 year | 
| Quality of life questionnaire (EQ-5D). | Measured with EuroQuol 5-D test Its a subjective test which goes from 0 to 100 in quality of life perception. Assessments: Baseline, hospital discharge, after 4 month and after 1 year. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Rehabilitation, Respiratory Muscle Training, Quality of Life