Inspiratory Muscle Training in Burned Adults (Burns)

March 12, 2024 updated by: Maged Basha, Qassim University

Effects of Adding Inspiratory Muscle Training to Pulmonary Rehabilitation Program in Adults With Burn Injuries: A Randomized Controlled Trial

The study outlines burn injury impact, emphasizes need for long-term rehabilitation. Study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients.

Study Overview

Status

Completed

Conditions

Detailed Description

The study aimed to evaluate the effectiveness of adding inspiratory muscle training to pulmonary rehabilitation in adult burn patients. Fifty-two participants were randomly assigned to either inspiratory muscle training plus pulmonary rehabilitation or pulmonary rehabilitation alone for 8 weeks. Inspiratory muscle training consisted of using a Powerbreathe device for inspiratory muscle strengthening.

Study Type

Interventional

Enrollment (Actual)

52

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 Locations

    • Dokki
      • Giza, Dokki, Egypt, 11432
        • Faculty of physical therapy, Cairo University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Burn-injured adults aged 20-49.
  • Admitted to the clinic after acute treatment.
  • Recovering from burns affecting at least 20% total body surface area.
  • Partial or full-thickness burns.

Exclusion Criteria:

  • Smokers.
  • had open or unhealed wounds.
  • had any known neurological deficit.
  • neuromuscular diseases.
  • musculoskeletal deformities.
  • pulmonary diseases.
  • severe cardiac problems.
  • inability to participate in regular exercise.

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: Respiratory muscle training group
Received inspiratory muscle training plus pulmonary rehabilitation program. Powerbreathe device was used for the exercise of the inspiratory muscle strength. Strengthening the inspiratory muscles with the Powerbreathe is similar to weightlifting to strengthen other muscles in the body.
The training consisted of 6 sets of 30 breaths per day, divided into 2 sessions per day. A one-minute rest interval between each set. Training was prescribed 5 days a week for 8 weeks
Other Names:
  • inspiratory muscle training
Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks
Other Names:
  • Resistance exercise
Experimental: Pulmonary rehabilitation group
Received pulmonary rehabilitation program for five sessions per week for 8 weeks. Four resistive exercises, aerobic exercise, and deep breathing exercises, aerobic conditioning exercises on the treadmill. All exercises were performed using variable resistance machines.
Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks
Other Names:
  • Resistance exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal inspiratory pressure
Time Frame: At the beginning of intervention
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
At the beginning of intervention
maximal inspiratory pressure
Time Frame: After 8 weeks of intervention
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
After 8 weeks of intervention
maximal expiratory pressure
Time Frame: At the beginning of intervention
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
At the beginning of intervention
maximal expiratory pressure
Time Frame: After 8 weeks of intervention
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
After 8 weeks of intervention
Forced expiratory volume in 1 second
Time Frame: At the beginning of intervention
performed using a spirometer
At the beginning of intervention
Forced expiratory volume in 1 second
Time Frame: After 8 weeks of intervention
performed using a spirometer
After 8 weeks of intervention
forced vital capacity
Time Frame: At the beginning of intervention
performed using a spirometer
At the beginning of intervention
forced vital capacity
Time Frame: After 8 weeks of intervention
performed using a spirometer
After 8 weeks of intervention
Forced expiratory volume in 1 second/ forced vital capacity ratio
Time Frame: At the beginning of intervention
performed using a spirometer
At the beginning of intervention
Forced expiratory volume in 1 second/ forced vital capacity ratio
Time Frame: After 8 weeks of intervention
performed using a spirometer
After 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: At the beginning of intervention
assessed using the six-minute walk test
At the beginning of intervention
Functional exercise capacity
Time Frame: After 8 weeks of intervention
assessed using the six-minute walk test
After 8 weeks of intervention

Collaborators and Investigators

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

Collaborators

Investigators

  • Principal Investigator: FatmaAlzahraa Kamel, PhD, Cairo University
  • Study Chair: Maged Basha, PhD, Qassim 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.

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)

January 15, 2021

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

September 11, 2023

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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