NCT05190497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

December 11, 2021

Last Update Submit

December 29, 2021

Conditions

Inhalation InjuryPulmonary FunctionRespiratory Muscle Strength

Keywords

INSPIRATORT TRAINING -INHALATION INJURY

Outcome Measures

Primary Outcomes (2)

  • 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).

    3 MONTHS

  • 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

    3 MONTHS

Study Arms (2)

intervention group

EXPERIMENTAL

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

Device: Exercise group

control

NO INTERVENTION

The Control group received only routine chest physiotherapy

Interventions

Exercise groupDEVICE

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

Also known as: INSPIRATORY MUSCLE TRAINING
intervention group

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khaled Takey Ahmed

Giza, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29657376BACKGROUND

Study Officials

  • Maha A El monem, Ass Prof

    Cairo University

    STUDY CHAIR

Central Study Contacts

KHALED T AHMED, Asso Prof

CONTACT

00201115586016khaled.takey@must.edu.eg

Assma F attallah, Ass Prof

CONTACT

00201117744974Zayedsameh40@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asssociate Professor

Study Record Dates

First Submitted

December 11, 2021

First Posted

January 13, 2022

Study Start

November 30, 2021

Primary Completion

February 15, 2022

Study Completion

February 28, 2022

Last Updated

January 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

At first study protocol and informed consent

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
november 2021 - february 2022
Access Criteria
web address

Locations

EG(1)