RMT in Patients With Spinal Cord Injury

Not Applicable

Withdrawn

• Conditions: Spinal Cord Injuries
• Interventions: Other: Control; Other: Experimental

• Registration Number: NCT04243161
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-01
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-23
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Control	Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement.
Group 1	Experimental	Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement.

Primary Outcome Measures

Name	Time	Method
Maximum respiratory pressures (PIM and PEM)	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).	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)	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).	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of independence in spinal cord injury and respiratory function	Through study completion, an average of 1 year	Measured with SCIM III Test; Assessments: Baseline, hospital discharge, after 4 month and after 1 year.
Quality of life questionnaire (EQ-5D).	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron Research Institute; 🇪🇸 Barcelona, Spain