NCT04020562

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 13, 2019

Last Update Submit

July 13, 2019

Conditions

Spinal Cord Injuries

Keywords

Pulmonary Function TestSpinal CordBreathing ExerciseExpiratory

Outcome Measures

Primary Outcomes (4)

  • Peak Expiratory Flow (PEF)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second

    5th week

  • Forced Expiratory Volume in 1 second (FEV1)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

    5th week

  • Forced vital Capacity (FVC)

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

    5th Week

  • FEV1/ FVC Ratio

    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze ratio between Forced Expiratory Volume in 1 second and Forced vital Capacity.

    5th Week

Secondary Outcomes (2)

  • Satisfaction with Life Scale (SWLS)

    5th week

  • The Patient Health Questionnaire (PHQ-9)

    5th Week

Study Arms (2)

Mild Resistive Expiratory Technique

EXPERIMENTAL

Mild resistive Expiratory Technique from EMST150- five-week training protocol.

Other: Mild Resistive Expiratory Technique

Conventional Training

ACTIVE COMPARATOR

Breathing exercise, Assistive Coughing, ROM Exercises, Sustained stretching, Splinting, Bracing, Functional Mobility, Tilt table standing

Other: Conventional Training

Interventions

Mild Resistive Expiratory TechniqueOTHER

Mild Resistive Expiratory Technique (EMST150- five-week training protocol): The EMST requires the participant to forcibly blow into the device for 5 seconds with sufficient pressure to open the one-way valve. Each "blow" is one repetition. The device will be set at a resistance of 30 cmH2O. Participants will be instructed to complete five sets of five repetitions (total of 25 times and approximately 20 minutes per day), any five days per week, for five weeks. Whole exercise will be done in sitting position. Rest between repetitions will be given according to comfort level of patient.

Mild Resistive Expiratory Technique
Conventional TrainingOTHER

Breathing exercise: Deep breathing 10-15 repetitions twice a day. Assistive Coughing: 5-6 repetitions twice a day. ROM Exercises: Both active and passive limb ROM exercises 10-15 repetitions twice a day. Sustained stretching: Both upper and lower limbs, 10 repetitions, held for 5 seconds, twice a day. Splinting: According to patient's injury level Bracing: According to patient's injury level Functional Mobility: Mobilizing patient according to injury level Tilt table standing: 10-15 minutes once a day

Conventional Training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 19442929BACKGROUND

  • 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.

    PMID: 16626951BACKGROUND

  • 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.

    PMID: 25957283BACKGROUND

  • Darain H, Muhammad Ilyas S, Zeb A, Ullah I, Muhammad D. Epidemiology of Spinal Cord Injury in Pakistan: A Retrospective Study2017. 106-9 p.

    BACKGROUND

  • 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.

    PMID: 20510974BACKGROUND

  • 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.

    PMID: 22628108BACKGROUND

  • 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.

    PMID: 9267921BACKGROUND

  • 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.

    PMID: 16367493BACKGROUND

  • 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.

    PMID: 11556941BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2019

First Posted

July 16, 2019

Study Start

February 20, 2019

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)