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Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

Primary Purpose

Inhalation Injury, Pulmonary Function, Respiratory Muscle Strength

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Exercise group

About this trial

This is an interventional treatment trial for Inhalation Injury focused on measuring INSPIRATORT TRAINING -INHALATION INJURY

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Khaled Takey AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control

Arm Description

inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation)

The Control group received only routine chest physiotherapy

Outcomes

Primary Outcome Measures

PULMONARY FUNCTION TEST

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).

Respiratory muscles Strength Measurement

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05190497

First Posted

December 11, 2021

Last Updated

December 29, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05190497

Brief Title

Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 30, 2021 (Actual)

Primary Completion Date

February 15, 2022 (Anticipated)

Study Completion Date

February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inhalation Injury, Pulmonary Function, Respiratory Muscle Strength

Keywords

INSPIRATORT TRAINING -INHALATION INJURY

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The exercise group received inspiratory muscle training in addition to routine chest physiotherapy (group A). The Control group received only routine chest physiotherapy (group B).

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation)

Arm Title

control

Arm Type

No Intervention

Arm Description

The Control group received only routine chest physiotherapy

Intervention Type

Device

Intervention Name(s)

Exercise group

Other Intervention Name(s)

INSPIRATORY MUSCLE TRAINING

Intervention Description

Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter

Primary Outcome Measure Information:

Title

PULMONARY FUNCTION TEST

Description

Time Frame

3 MONTHS

Title

Respiratory muscles Strength Measurement

Description

Time Frame

3 MONTHS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

KHALED T AHMED, Asso Prof

Phone

00201115586016

khaled.takey@must.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Assma F attallah, Ass Prof

Phone

00201117744974

Zayedsameh40@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maha A El monem, Ass Prof

Organizational Affiliation

Cairo University

Official's Role

Study Chair

Facility Information:

Facility Name

Khaled Takey Ahmed

City

Giza

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

Phone

0201115586016

khaled.takey@must.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

At first study protocol and informed consent

IPD Sharing Time Frame

november 2021 - february 2022

IPD Sharing Access Criteria

web address

Citations:

PubMed Identifier

29657376

Citation

Gupta K, Mehrotra M, Kumar P, Gogia AR, Prasad A, Fisher JA. Smoke Inhalation Injury: Etiopathogenesis, Diagnosis, and Management. Indian J Crit Care Med. 2018 Mar;22(3):180-188. doi: 10.4103/ijccm.IJCCM_460_17.

Results Reference

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Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

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