Clinical trial NCT04243161: RMT in Patients With Spinal Cord Injury
Official title: Respiratory Muscle Training in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Rehabilitation
Respiratory Muscle Training
Quality of Life
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Maximum respiratory pressures (PIM and PEM)
timeFrame: Through study completion, an average of 1 year
measure: Peak Cough Flow (PCF).
timeFrame: Through study completion, an average of 1 year
measure: Forced Spirometry (FVC).
timeFrame: Through study completion, an average of 1 year
measure: Peak expiratory Flow (PEF)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Measurement of independence in spinal cord injury and respiratory function
timeFrame: Through study completion, an average of 1 year
measure: Quality of life questionnaire (EQ-5D).
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron Research Institute
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Bernat Planas Pascual, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: Berlowitz DJ, Tamplin J. Respiratory muscle training for cervical spinal cord injury. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD008507. doi: 10.1002/14651858.CD008507.pub2.