- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06315712
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
Intervention / Treatment
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
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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:
Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks
Other Names:
|
|
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:
|
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.
Sponsor
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.
General Publications
- Willis CE, Grisbrook TL, Elliott CM, Wood FM, Wallman KE, Reid SL. Pulmonary function, exercise capacity and physical activity participation in adults following burn. Burns. 2011 Dec;37(8):1326-33. doi: 10.1016/j.burns.2011.03.016. Epub 2011 May 6.
- Ozkal O, Topuz S, Karahan S, Erdem MM, Konan A, Yasti AC. Clinical predictors of pulmonary functions, respiratory/peripheral muscle strength and exercise capacity at discharge in adults with burn injury. Disabil Rehabil. 2021 Oct;43(20):2875-2881. doi: 10.1080/09638288.2020.1720320. Epub 2020 Jan 30.
- Gittings PM, Grisbrook TL, Edgar DW, Wood FM, Wand BM, O'Connell NE. Resistance training for rehabilitation after burn injury: A systematic literature review & meta-analysis. Burns. 2018 Jun;44(4):731-751. doi: 10.1016/j.burns.2017.08.009. Epub 2017 Oct 7. Erratum In: Burns. 2020 Aug;46(5):1240-1241.
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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