Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

December 29, 2021 updated by: Khaled Takey Ahmed, Cairo University

Effects of Inspiratory Muscle Training on Clinical Predictors of Respiratory Muscle Strength and Lung Function in Burned Patients With Inhalation Injury

The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an improvement in respiratory muscle function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty male patients suffering from inhalation injury were been included in this study, Participants' ages ranged from 20-35 years old. Patients were selected from the burn department, Om El-Masreen hospital, and randomly assigned into two equal groups.

The exercise group received inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) three times per week for four weeks (group A). The Control group received only routine chest physiotherapy (group B). This study obtained ethical approval by the institutional review board of the Faculty of Physical Therapy - Cairo University, with reference number: P.T.REC/012/003431

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male patients suffering from inhalation injury.
  • Participant age ranged from 20-35 years old.
  • All patients had the same medical care.
  • Participants have received a good explanation of the treatment and measurement device.
  • Treatment was conducted one month after inhalation injury.

Exclusion criteria:

Patients were excluded from this study for any of the following cases such as

  • Instability of patient's medical condition.
  • Presence of any diseases that could affect the study results.
  • Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation)
Device: Exercise group
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter
Other Names:
  • INSPIRATORY MUSCLE TRAINING
No Intervention: control
The Control group received only routine chest physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PULMONARY FUNCTION TEST
Time Frame: 3 MONTHS
Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).
3 MONTHS
Respiratory muscles Strength Measurement
Time Frame: 3 MONTHS
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter (Pony FX; COSMED, Rome, Italy) in the sitting position. The highest maximal expiratory pressure (MEP) in cmH2O, and maximal inspiratory pressure (MIP) in cmH2O values in three or more attempts were chosen. Investigators calculated the predicted MEP and MIP values based on age, height, and weight
3 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Maha A El monem, Ass Prof, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Anticipated)

February 15, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

December 11, 2021

First Submitted That Met QC Criteria

December 29, 2021

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMT in inhalation injury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At first study protocol and informed consent

IPD Sharing Time Frame

november 2021 - february 2022

IPD Sharing Access Criteria

web address

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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