RMT in Patients With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Respiratory Muscle Training in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04243161
• Other study ID #: PR(AG)26/2018
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. Review. — View Citation

Galeiras Vázquez R, Rascado Sedes P, Mourelo Fariña M, Montoto Marqués 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. Review. — View Citation

Göhl O, Walker DJ, Walterspacher S, Langer D, Spengler CM, Wanke T, Petrovic M, Zwick RH, Stieglitz S, Glöckl 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 201 — View 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 — View 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.2 — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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