RMT in Patients With Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental
Control
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Rehabilitation, Respiratory Muscle Training, Quality of Life
Eligibility 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.
Sites / Locations
- Hospital Universitari Vall d'Hebron Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement.
Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04243161
First Posted
January 20, 2020
Last Updated
January 23, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04243161
Brief Title
RMT in Patients With Spinal Cord Injury
Official Title
Respiratory Muscle Training in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
lack of time
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injury, Rehabilitation, Respiratory Muscle Training, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Common clinical practice (pulmonary expansion exercises, drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
High intensity training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Usual intensity training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maximum respiratory pressures (PIM and PEM)
Description
Measured with respiratory pressure gauge
Assessments:
Baseline, every two weeks while patient still admitted in hospital, after 4 month and after 1 year.
Time Frame
Through study completion, an average of 1 year
Title
Peak Cough Flow (PCF).
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Forced Spirometry (FVC).
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Peak expiratory Flow (PEF)
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Measurement of independence in spinal cord injury and respiratory function
Description
Measured with SCIM III Test
Assessments:
Baseline, hospital discharge, after 4 month and after 1 year.
Time Frame
Through study completion, an average of 1 year
Title
Quality of life questionnaire (EQ-5D).
Description
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.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernat Planas Pascual, PT, MSc
Organizational Affiliation
Hospital Universitari Vall d'Hebron Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Vall d'Hebron Research Institute
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26789431
Citation
Gohl O, Walker DJ, Walterspacher S, Langer D, Spengler CM, Wanke T, Petrovic M, Zwick RH, Stieglitz S, Glockl R, Dellweg D, Kabitz HJ. [Respiratory Muscle Training: State of the Art]. Pneumologie. 2016 Jan;70(1):37-48. doi: 10.1055/s-0041-109312. Epub 2016 Jan 20. German.
Results Reference
result
PubMed Identifier
25448189
Citation
Mitchell MD, Yarossi MB, Pierce DN, Garbarini EL, Forrest GF. Reliability of surface EMG as an assessment tool for trunk activity and potential to determine neurorecovery in SCI. Spinal Cord. 2015 May;53(5):368-74. doi: 10.1038/sc.2014.171. Epub 2014 Dec 2.
Results Reference
result
PubMed Identifier
25082923
Citation
Postma K, Haisma JA, Hopman MT, Bergen MP, Stam HJ, Bussmann JB. Resistive inspiratory muscle training in people with spinal cord injury during inpatient rehabilitation: a randomized controlled trial. Phys Ther. 2014 Dec;94(12):1709-19. doi: 10.2522/ptj.20140079. Epub 2014 Jul 31.
Results Reference
result
PubMed Identifier
24418958
Citation
Tamplin J, Berlowitz DJ. A systematic review and meta-analysis of the effects of respiratory muscle training on pulmonary function in tetraplegia. Spinal Cord. 2014 Mar;52(3):175-80. doi: 10.1038/sc.2013.162. Epub 2014 Jan 14.
Results Reference
result
PubMed Identifier
24089664
Citation
Galeiras Vazquez R, Rascado Sedes P, Mourelo Farina M, Montoto Marques A, Ferreiro Velasco ME. Respiratory management in the patient with spinal cord injury. Biomed Res Int. 2013;2013:168757. doi: 10.1155/2013/168757. Epub 2013 Sep 9.
Results Reference
result
PubMed Identifier
23999001
Citation
Terson de Paleville D, McKay W, Aslan S, Folz R, Sayenko D, Ovechkin A. Locomotor step training with body weight support improves respiratory motor function in individuals with chronic spinal cord injury. Respir Physiol Neurobiol. 2013 Dec 1;189(3):491-7. doi: 10.1016/j.resp.2013.08.018. Epub 2013 Aug 31.
Results Reference
result
PubMed Identifier
23881660
Citation
Berlowitz DJ, Tamplin J. Respiratory muscle training for cervical spinal cord injury. Cochrane Database Syst Rev. 2013 Jul 23;(7):CD008507. doi: 10.1002/14651858.CD008507.pub2.
Results Reference
result
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RMT in Patients With Spinal Cord Injury
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