RMT in Patients With Spinal Cord Injury

January 23, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Respiratory Muscle Training in Patients With Spinal Cord Injury

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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

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.

Other Names:
  • High intensity training
Active Comparator: Group 2
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

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.

Other Names:
  • Usual intensity training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum respiratory pressures (PIM and PEM)
Time Frame: 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.
Through study completion, an average of 1 year
Peak Cough Flow (PCF).
Time Frame: 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.
Through study completion, an average of 1 year
Forced Spirometry (FVC).
Time Frame: 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.
Through study completion, an average of 1 year
Peak expiratory Flow (PEF)
Time Frame: 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.
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
Time Frame: Through study completion, an average of 1 year

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).
Time Frame: 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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: Bernat Planas Pascual, PT, MSc, Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)26/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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