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出境医 / 临床实验 / Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: Mild Resistive Expiratory Technique Other: Conventional Training Not Applicable

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of a Mild Resistive Expiratory Technique on Pulmonary Functions of Spinal Cord Injury
Actual Study Start Date : February 20, 2019
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : June 15, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Mild Resistive Expiratory Technique
Mild resistive Expiratory Technique from EMST150- five-week training protocol.
Other: Mild Resistive Expiratory Technique

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.


Active Comparator: Conventional Training
Breathing exercise, Assistive Coughing, ROM Exercises, Sustained stretching, Splinting, Bracing, Functional Mobility, Tilt table standing
Other: Conventional Training

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


Outcome Measures
Primary Outcome Measures :
  1. Peak Expiratory Flow (PEF) [ Time Frame: 5th week ]
    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second

  2. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 5th week ]
    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters

  3. Forced vital Capacity (FVC) [ Time Frame: 5th Week ]
    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters

  4. FEV1/ FVC Ratio [ Time Frame: 5th Week ]
    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 :
  1. Satisfaction with Life Scale (SWLS) [ Time Frame: 5th week ]
    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

  2. The Patient Health Questionnaire (PHQ-9) [ Time Frame: 5th Week ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Pakistan
Riphah International University
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
Layout table for investigator information
Principal Investigator: Iqbal Tariq, MSCPPT Riphah International University
Tracking Information
First Submitted Date  ICMJE July 13, 2019
First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE February 20, 2019
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • Peak Expiratory Flow (PEF) [ Time Frame: 5th week ]
    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) [ Time Frame: 5th week ]
    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) [ Time Frame: 5th Week ]
    Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
  • FEV1/ FVC Ratio [ Time Frame: 5th Week ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2019)
  • Satisfaction with Life Scale (SWLS) [ Time Frame: 5th week ]
    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) [ Time Frame: 5th Week ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury
Official Title  ICMJE Effects of a Mild Resistive Expiratory Technique on Pulmonary Functions of Spinal Cord Injury
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Other: Mild Resistive Expiratory Technique

    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.

  • Other: Conventional Training

    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

Study Arms  ICMJE
  • Experimental: Mild Resistive Expiratory Technique
    Mild resistive Expiratory Technique from EMST150- five-week training protocol.
    Intervention: Other: Mild Resistive Expiratory Technique
  • Active Comparator: Conventional Training
    Breathing exercise, Assistive Coughing, ROM Exercises, Sustained stretching, Splinting, Bracing, Functional Mobility, Tilt table standing
    Intervention: Other: Conventional Training
Publications *
  • 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. Review.
  • 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. Epub 2006 Apr 12. Review.
  • 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.
  • Darain H, Muhammad Ilyas S, Zeb A, Ullah I, Muhammad D. Epidemiology of Spinal Cord Injury in Pakistan: A Retrospective Study2017. 106-9 p.
  • 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.
  • 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.
  • 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.
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2019
Actual Primary Completion Date June 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04020562
Other Study ID Numbers  ICMJE RiphahIU Faiza Irshad
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Riphah International University
Study Sponsor  ICMJE Riphah International University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Iqbal Tariq, MSCPPT Riphah International University
PRS Account Riphah International University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP