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NCT Number: NCT04020562

Mild Resistive Expiratory Breathing Technique On 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

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mild Resistive Expiratory Technique

Other

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 training

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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