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Spinal Cord InjuriesNCT04020562

Mild Resistive Expiratory Breathing Technique On Spinal Cord Injury

A study testing Mild Resistive Expiratory Technique and Conventional Training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Mild Resistive Expiratory Technique and Conventional Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
20 Feb 2019to 15 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah International University

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Effects of a Mild Resistive Expiratory Technique on Pulmonary Functions of Spinal Cord Injury

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

Read the 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

Being tested
Mild Resistive Expiratory Technique, Conventional Training
Keywords
Pulmonary Function Test, Spinal Cord, Breathing Exercise, Expiratory
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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

Study groups in NCT04020562
Study groupRoleWhat they receive
Mild Resistive Expiratory TechniqueExperimentalMild resistive Expiratory Technique from EMST150- five-week training protocol.
Receives: Other: Mild Resistive Expiratory Technique
Conventional TrainingActive comparatorBreathing exercise, Assistive Coughing, ROM Exercises, Sustained stretching, Splinting, Bracing, Functional Mobility, Tilt table standing
Receives: Other: Conventional Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5th week

  2. 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

    Measured: 5th week

  3. Forced vital Capacity (FVC)

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

    Measured: 5th Week

  4. 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.

    Measured: 5th Week

Secondary outcomes (2)

  1. 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

    Measured: 5th week

  2. 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

    Measured: 5th Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start20 Feb 2019
  3. Primary completion15 Jun 2019
  4. Study completion15 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04020562
Sponsor's protocol ID
RiphahIU Faiza Irshad
Status last verified
Jul 2019
First submitted
13 Jul 2019
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 19442929

  • 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.

    PubMed 16626951

  • 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.

    PubMed 25957283

  • 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.

    PubMed 20510974

  • 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.

    PubMed 22628108

  • 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.

    PubMed 9267921

  • 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.

    PubMed 16367493

  • 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.

    PubMed 11556941

Questions about this trial

What is this clinical trial studying?

A study testing Mild Resistive Expiratory Technique and Conventional Training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Expiratory Flow (PEF) (time frame: 5th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04020562, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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