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Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mild Resistive Expiratory Technique
Conventional Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Pulmonary Function Test, Spinal Cord, Breathing Exercise, Expiratory

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mild Resistive Expiratory Technique

Conventional Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction with Life Scale (SWLS)
It is a 5-item scale designed to measure the global cognitive perceptions of an individual's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items in the questionnaire using a 7-point scale that ranges from 7 which corresponds to "strongly agree" to 1 which corresponds to "strongly disagree" . This scale shows good convergent validity with other scales and with other types of assessments of subjective well-being. SWLS shows high internal consistency and high temporal reliability. It has shown to have sufficient sensitivity to detect changes in life satisfaction during the period of clinical intervention. Changes from baseline
The Patient Health Questionnaire (PHQ-9)
It is a 9-item self-administered questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression. It rates the frequency of symptoms. Each question has scale of answers from 0 which represents "not at all" to 3 which represents "nearly every day". The diagnostic validity of this questionnaire was assessed by using it on 6000 patients in 8 primary care clinics and 7 obstetrical clinics. A score of >10 on PHQ-9 had both sensitivity and specificity of 88% for major depression. PHQ-9 score of 5 represents mild, while 10, 15, and 20 represent moderate, moderately severe, and severe depression respectively

Full Information

First Posted
July 13, 2019
Last Updated
July 13, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04020562
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Pulmonary Function Test, Spinal Cord, Breathing Exercise, Expiratory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Resistive Expiratory Technique
Arm Type
Experimental
Arm Description
Mild resistive Expiratory Technique from EMST150- five-week training protocol.
Arm Title
Conventional Training
Arm Type
Active Comparator
Arm Description
Breathing exercise, Assistive Coughing, ROM Exercises, Sustained stretching, Splinting, Bracing, Functional Mobility, Tilt table standing
Intervention Type
Other
Intervention Name(s)
Mild Resistive Expiratory Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Peak Expiratory Flow (PEF)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second
Time Frame
5th week
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Time Frame
5th week
Title
Forced vital Capacity (FVC)
Description
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Time Frame
5th Week
Title
FEV1/ FVC Ratio
Description
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.
Time Frame
5th Week
Secondary Outcome Measure Information:
Title
Satisfaction with Life Scale (SWLS)
Description
It is a 5-item scale designed to measure the global cognitive perceptions of an individual's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items in the questionnaire using a 7-point scale that ranges from 7 which corresponds to "strongly agree" to 1 which corresponds to "strongly disagree" . This scale shows good convergent validity with other scales and with other types of assessments of subjective well-being. SWLS shows high internal consistency and high temporal reliability. It has shown to have sufficient sensitivity to detect changes in life satisfaction during the period of clinical intervention. Changes from baseline
Time Frame
5th week
Title
The Patient Health Questionnaire (PHQ-9)
Description
It is a 9-item self-administered questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression. It rates the frequency of symptoms. Each question has scale of answers from 0 which represents "not at all" to 3 which represents "nearly every day". The diagnostic validity of this questionnaire was assessed by using it on 6000 patients in 8 primary care clinics and 7 obstetrical clinics. A score of >10 on PHQ-9 had both sensitivity and specificity of 88% for major depression. PHQ-9 score of 5 represents mild, while 10, 15, and 20 represent moderate, moderately severe, and severe depression respectively
Time Frame
5th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19442929
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.
Results Reference
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PubMed Identifier
16626951
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.
Results Reference
background
PubMed Identifier
25957283
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
20510974
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.
Results Reference
background
PubMed Identifier
22628108
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.
Results Reference
background
PubMed Identifier
9267921
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.
Results Reference
background
PubMed Identifier
16367493
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.
Results Reference
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PubMed Identifier
11556941
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.
Results Reference
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Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

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