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RMT in Patients With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243161
Recruitment Status : Withdrawn (lack of time)
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Experimental Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Respiratory Muscle Training in Patients With Spinal Cord Injury
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Usual intensity training




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243161


Locations
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Spain
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
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Principal Investigator: Bernat Planas Pascual, PT, MSc Hospital Universitari Vall d'Hebron Research Institute
Publications of Results:

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04243161    
Other Study ID Numbers: PR(AG)26/2018
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Spinal Cord Injury
Rehabilitation
Respiratory Muscle Training
Quality of Life
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System