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Clinical Trials/NCT04020562
NCT04020562CompletedNot Applicable

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

Riphah International University2 sites in 1 country60 target enrollmentStarted: February 20, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
FEV1/ FVC Ratio

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Mild Resistive Expiratory Technique

Experimental

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

Intervention: Mild Resistive Expiratory Technique (Other)

Conventional Training

Active Comparator

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

Intervention: Conventional Training (Other)

Outcomes

Primary Outcomes

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.

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 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

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

Secondary Outcomes

  • Satisfaction with Life Scale (SWLS)(5th week)
  • The Patient Health Questionnaire (PHQ-9)(5th Week)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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