Burn InjuriesBurnsNCT06315712
Inspiratory Muscle Training in Burned Adults
A study testing inspiratory exercise and Pulmonary rehabilitation in people with Burn Injuries, run by Qassim University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years
- Conditions the study is for
- Burn Injuries
- What is being tested?
- inspiratory exercise and Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2021to 11 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Burn Injuries
- Being tested
- inspiratory exercise, Pulmonary rehabilitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory exerciseOther
Also called inspiratory muscle training
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
Pulmonary rehabilitationOther
Also called Resistance exercise
Four resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Respiratory muscle training group | Experimental | 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. Receives: Other: inspiratory exercise; Other: Pulmonary rehabilitation |
| Pulmonary rehabilitation group | Experimental | 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. Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal inspiratory pressure
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
Measured: At the beginning of intervention
maximal inspiratory pressure
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
Measured: After 8 weeks of intervention
maximal expiratory pressure
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
Measured: At the beginning of intervention
maximal expiratory pressure
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
Measured: After 8 weeks of intervention
Forced expiratory volume in 1 second
performed using a spirometer
Measured: At the beginning of intervention
Forced expiratory volume in 1 second
performed using a spirometer
Measured: After 8 weeks of intervention
forced vital capacity
performed using a spirometer
Measured: At the beginning of intervention
forced vital capacity
performed using a spirometer
Measured: After 8 weeks of intervention
Forced expiratory volume in 1 second/ forced vital capacity ratio
performed using a spirometer
Measured: At the beginning of intervention
Forced expiratory volume in 1 second/ forced vital capacity ratio
performed using a spirometer
Measured: After 8 weeks of intervention
Secondary outcomes (2)
Functional exercise capacity
assessed using the six-minute walk test
Measured: At the beginning of intervention
Functional exercise capacity
assessed using the six-minute walk test
Measured: After 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start15 Jan 2021
- Primary completion16 Jun 2022
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burn InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- FatmaAlzahraa Kamel, PhD, Principal investigator, Cairo UniversityMaged Basha, PhD, Study chair, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315712
- Sponsor's protocol ID
- 004201
- Acronym
- Burns
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 21530086Ozkal 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.
PubMed 31999499Gittings 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.
PubMed 29017743
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adding Inspiratory Muscle Training to Pulmonary Rehabilitation Program in Adults With Burn Injuries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06315712
- Acronym / sponsor ID
- Burns / 004201
- Conditions
- Burn Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle training group | Experimental | Other: inspiratory exercise, Other: Pulmonary rehabilitationReceived 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. |
| Pulmonary rehabilitation group | Experimental | Other: Pulmonary rehabilitationReceived 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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Smokers.
- had open or unhealed wounds.
- had any known neurological deficit.
- neuromuscular diseases.
- musculoskeletal deformities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory exerciseAlso: inspiratory muscle trainingThe 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 | Respiratory muscle training group |
| Pulmonary rehabilitationAlso: Resistance exerciseFour resistive exercises, aerobic exercise, and deep breathing exercises, five sessions per week for 8 weeks | Other | Pulmonary rehabilitation group, Respiratory muscle training group |
Primary outcome
maximal inspiratory pressure
Time frame: At the beginning of intervention
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
maximal inspiratory pressure
Time frame: After 8 weeks of intervention
performed using an electronic respiratory pressure meter, measures inspiratory muscle strength
maximal expiratory pressure
Time frame: At the beginning of intervention
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
maximal expiratory pressure
Time frame: After 8 weeks of intervention
performed using an electronic respiratory pressure meter, assesses expiratory muscle strength.
Forced expiratory volume in 1 second
Time frame: At the beginning of intervention
performed using a spirometer
Forced expiratory volume in 1 second
Time frame: After 8 weeks of intervention
performed using a spirometer
forced vital capacity
Time frame: At the beginning of intervention
performed using a spirometer
forced vital capacity
Time frame: After 8 weeks of intervention
performed using a spirometer
Forced expiratory volume in 1 second/ forced vital capacity ratio
Time frame: At the beginning of intervention
performed using a spirometer
Forced expiratory volume in 1 second/ forced vital capacity ratio
Time frame: After 8 weeks of intervention
performed using a spirometer
2 secondary outcomes
Functional exercise capacity
Time frame: At the beginning of intervention
Functional exercise capacity
Time frame: After 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 21530086Willis 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.
- Background: PubMed 31999499Ozkal 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.
- Results publication: PubMed 29017743Gittings 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FatmaAlzahraa Kamel, PhD principal investigator
Cairo University
Maged Basha, PhD study chair
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory exercise and Pulmonary rehabilitation in people with Burn Injuries, run by Qassim University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal inspiratory pressure (time frame: At the beginning of intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06315712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.