Clinical trial NCT04020562: Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury
Official title: Effects of a Mild Resistive Expiratory Technique on Pulmonary Functions of Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Pulmonary Function Test
Spinal Cord
Breathing Exercise
Expiratory
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies have been conducted on the effectiveness of inspiratory muscle training on tetraplegics, and less has been reported on expiratory muscle training on paraplegics; especially in Pakistan there was no such study done up-to my knowledge. Paraplegic individuals develop pulmonary complications due to prolonged general immobilization of body and ineffective cough due to respiratory muscle weakness. This study will identify the effects of expiratory muscle training using "Expiratory Muscle Strength Trainer- 150" in paraplegic individuals in Peshawar, Pakistan

Detailed description: A study on the effects of accessory expiratory muscle training and showed that there was a significant improvement in vital capacity of experimental group. The investigator recruited 40 patients and randomly allocated them to control and experimental groups. Experimental group received expiratory muscle training for half hour a day, six days a week for eight weeks, which included training using PFLEX muscle trainer. Control group received conventional breathing exercises and assistance in coughing. Experimental group showed improvement in mean vital capacity from 1.48 to 1.98 liters and in mean expiratory muscle strength from 43.76 cmH2O to 68 cmH2O. Control group yielded no changes.

A respiratory muscle training and electrical stimulation of abdominal muscles on thirteen quadriplegic individuals to assess their respiratory function. The study consisted of training the patients for three months. Each subject was given one-month inspiratory training, followed by second month of expiratory muscle training, and then last month without training. Vital capacity showed 19% increase in the experimental group while control group showed no improvement .

A randomized controlled trial to assess the effect of expiratory muscle training on pulmonary function of 29 spinal cord injury patients in an acute inpatient rehabilitation hospital. Patients were randomized into two groups. Experimental group consisting of 16 patients received expiratory muscle training using EMST for 10 repetitions twice a day, 5 days a week, for 6 weeks. Control group consisted of 13 individuals and they received sham training. There was no significant difference reported between both groups

Eligibility criteria: Inclusion Criteria:

* Spinal Cord Injury (level T1 and Below)
* Paraplegic

Exclusion Criteria:

* Rib fractures
* Active inflammation or infection going in body
* Diagnosed (primary Lung Diseases)
* Individuals with psychiatric disorders or malignancies

Primary outcomes:
measure: Peak Expiratory Flow (PEF)
timeFrame: 5th week
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 5th week
measure: Forced vital Capacity (FVC)
timeFrame: 5th Week
measure: FEV1/ FVC Ratio
timeFrame: 5th Week
Secondary outcomes:
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 5th week
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 5th Week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schilero GJ, Spungen AM, Bauman WA, Radulovic M, Lesser M. Pulmonary function and spinal cord injury. Respir Physiol Neurobiol. 2009 May 15;166(3):129-41. doi: 10.1016/j.resp.2009.04.002. Epub 2009 Apr 9.
citation: Van Houtte S, Vanlandewijck Y, Gosselink R. Respiratory muscle training in persons with spinal cord injury: a systematic review. Respir Med. 2006 Nov;100(11):1886-95. doi: 10.1016/j.rmed.2006.02.029. Epub 2006 Apr 12.
citation: Majdan M, Brazinova A, Mauritz W. Epidemiology of traumatic spinal cord injuries in Austria 2002-2012. Eur Spine J. 2016 Jan;25(1):62-73. doi: 10.1007/s00586-015-3985-z. Epub 2015 May 9.
citation: Darain H, Muhammad Ilyas S, Zeb A, Ullah I, Muhammad D. Epidemiology of Spinal Cord Injury in Pakistan: A Retrospective Study2017. 106-9 p.
citation: Roth EJ, Stenson KW, Powley S, Oken J, Primack S, Nussbaum SB, Berkowitz M. Expiratory muscle training in spinal cord injury: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Jun;91(6):857-61. doi: 10.1016/j.apmr.2010.02.012.
citation: Anand S, El-Bashiti N, Sapienza C. Effect of training frequency on maximum expiratory pressure. Am J Speech Lang Pathol. 2012 Nov;21(4):380-6. doi: 10.1044/1058-0360(2012/11-0048). Epub 2012 May 24.
citation: Zupan A, Savrin R, Erjavec T, Kralj A, Karcnik T, Skorjanc T, Benko H, Obreza P. Effects of respiratory muscle training and electrical stimulation of abdominal muscles on respiratory capabilities in tetraplegic patients. Spinal Cord. 1997 Aug;35(8):540-5. doi: 10.1038/sj.sc.3100433.
citation: Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.