BurnNCT07867639
Impact of Inspiratory Muscle Training Post-Burn
A study testing Inspiratory muscle training and Conventional physical therapy in people with Burn, run by Cairo University at 1 site in Egypt.
Trial summary
Pulmonary dysfunction can be developed as a result of complications caused by direct thermal injury to the respiratory tract, smoke irritations, and respiratory tract infection. Although the survival rates of patients with burn injury have increased because of improved acute management, pulmonary complications have… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Burn
- What is being tested?
- Inspiratory muscle training and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with inhalation injury after thermal burn injury including face and chest
- with 40-60 % of total body surface area (%TBSA)
- Partial or full thickness burns that either recovered spontaneously or healed by skin grafting
- Age (20-50) years.
Who cannot join
- Cerebrovascular disease
- Heavy smokers
- Open or unhealed wounds
- Chest physical therapy before enrollment
- Any lung disorders (COPD or asthma)
- musculoskeletal impairment
Show all 12Show fewer
- Neurological impairment
- Cardiac diseases
- Cognitive disorders
- Obese individuals BMI ≥ 30 kg/m2
- Pregnant females
- Participants in intensive care unit who are intubated and depend on mechanical ventilation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy, Cairo University
Giza
Nesma M Allam, PhD, 01281968332, dr.nesma2011@yahoo.com
Nesma M Allam, PhD, dr.nesma2011@yahoo.com
About this study
Official title: Impact of Inspiratory Muscle Training on Respiratory Muscle Strength, Balance and Postural Stability Post-Burn: A Randomized Controlled Study.
Pulmonary dysfunction can be developed as a result of complications caused by direct thermal injury to the respiratory tract, smoke irritations, and respiratory tract infection. Although the survival rates of patients with burn injury have increased because of improved acute management, pulmonary complications have continued to be the main cause of mortality in patients with burns. The patients who survive suffer from persistent physiological impairments, limited aerobic capacity, increased skeletal muscle catabolism, and decreased muscle strength/endurance. Rehabilitation strategies for the long-term recovery in patients with burns aim to improve the physical function and independence in daily activities.
- Conditions
- Burn
- Being tested
- Inspiratory muscle training, Conventional physical therapy
- Keywords
- Inspiratory muscle training, Balance, Postural stability, Burn, Respiratory muscle strength
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Participants in the experimental group will receive Inspiratory muscle training device, in addition to conventional physical therapy program. Initially, participants will be asked to perform three sets of 30 breaths on the POWER breathe to adjust the load and become familiar with the device. The training will include six 30-breath sets each day, divided into two sessions each. There is a one-minute rest time between each set. The inspiratory muscle load for training will be 50% of maximum inspiratory pressure (MIP), and it will be reviewed and changed weekly.
Conventional physical therapyOther
Conventional physical therapy exercise program in the form of respiratory physical therapy, balance and aerobic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Study group (Inspiratory muscle training) | Experimental | Participants will receive Inspiratory muscle training followed by conventional physical therapy program Receives: Device: Inspiratory muscle training; Other: Conventional physical therapy |
| Control group | Active comparator | Participants will receive conventional physical therapy program (respiratory physical therapy, balance and aerobic exercises) Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength (Maximum Inspiratory Pressure)
Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed by measuring the maximum inspiratory pressure (MIP) using a respiratory pressure meter. MIP will be recorded in cmH₂O, with higher values indicating greater inspiratory muscle strength.
Measured: 8 weeks
Secondary outcomes (5)
Respiratory muscle strength (Maximum expiratory Pressure)
Maximum Expiratory Pressure (MEP): Expiratory muscle strength will be assessed by measuring the maximum expiratory pressure (MEP) using a respiratory pressure meter. MEP will be recorded in cmH₂O, with higher values indicating greater expiratory muscle strength.
Measured: 8 weeks
Balance
Static and dynamic balance of the participants will be assessed through the Berg Balance Scale (BBS) where the patient has to perform 14 predetermined physical tasks assessing different aspects of balance. These include static, anticipatory, dynamic and sensory balance. Each task will be scored from 0 to 4 where 4 indicates the person can complete the task independently with a final maximal score of 56. Higher scores indicate better balance performance.
Measured: 8 weeks
Postural stability (Overall Stability Index)
Overall Stability Index (OSI): Postural stability will be assessed using the Biodex Postural Stability System (Biodex Medical Systems, Shirley, NY, USA). The Overall Stability Index (OSI) will be recorded as an indicator of overall postural stability, with lower values indicating better stability.
Measured: 8 weeks
Postural stability (Anterior-Posterior Index)
Anterior-Posterior Index (API): The Anterior-Posterior Stability Index (API) will be measured using the Biodex Postural Stability System (Biodex Medical Systems, Shirley, NY, USA) to assess postural stability in the anterior-posterior direction. Lower values indicate better stability.
Measured: 8 weeks
Postural stability (Mediolateral Index)
Mediolateral Index (MLI): The Mediolateral Stability Index (MLI) will be measured using the Biodex Postural Stability System (Biodex Medical Systems, Shirley, NY, USA) to assess postural stability in the mediolateral direction. Lower values indicate better stability.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start8 Oct 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867639
- Sponsor's protocol ID
- P.T.REC/012/006577
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Inspiratory Muscle Training on Respiratory Muscle Strength, Balance and Postural Stability Post-Burn: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT07867639
- Acronym / sponsor ID
- P.T.REC/012/006577
- Conditions
- Burn
- Keywords
- Inspiratory muscle training, Balance, Postural stability, Burn, Respiratory muscle strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Oct 2026 (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.
Pulmonary dysfunction can be developed as a result of complications caused by direct thermal injury to the respiratory tract, smoke irritations, and respiratory tract infection. Although the survival rates of patients with burn injury have increased because of improved acute management, pulmonary complications have continued to be the main cause of mortality in patients with burns. The patients who survive suffer from persistent physiological impairments, limited aerobic capacity, increased skeletal muscle catabolism, and decreased muscle strength/endurance. Rehabilitation strategies for the long-term recovery in patients with burns aim to improve the physical function and independence in daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (Inspiratory muscle training) | Experimental | Device: Inspiratory muscle training, Other: Conventional physical therapyParticipants will receive Inspiratory muscle training followed by conventional physical therapy program |
| Control group | Active comparator | Other: Conventional physical therapyParticipants will receive conventional physical therapy program (respiratory physical therapy, balance and aerobic exercises) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with inhalation injury after thermal burn injury including face and chest
- with 40-60 % of total body surface area (%TBSA)
- Partial or full thickness burns that either recovered spontaneously or healed by skin grafting
- Age (20-50) years.
Key exclusion criteria (12 listed)
- Cerebrovascular disease
- Heavy smokers
- Open or unhealed wounds
- Chest physical therapy before enrollment
- Any lung disorders (COPD or asthma)
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 muscle trainingParticipants in the experimental group will receive Inspiratory muscle training device, in addition to conventional physical therapy program. Initially, participants will be asked to perform three sets of 30 breaths on the POWER breathe to adjust the load and become familiar with the device. The training will include six 30-breath sets each day, divided into two sessions each. There is a one-minute rest time between each set. The inspiratory muscle load for training will be 50% of maximum inspiratory pressure (MIP), and it will be reviewed and changed weekly. | Device | Study group (Inspiratory muscle training) |
| Conventional physical therapyConventional physical therapy exercise program in the form of respiratory physical therapy, balance and aerobic exercises. | Other | Control group, Study group (Inspiratory muscle training) |
Primary outcome
Respiratory muscle strength (Maximum Inspiratory Pressure)
Time frame: 8 weeks
Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed by measuring the maximum inspiratory pressure (MIP) using a respiratory pressure meter. MIP will be recorded in cmH₂O, with higher values indicating greater inspiratory muscle strength.
5 secondary outcomes
Respiratory muscle strength (Maximum expiratory Pressure)
Time frame: 8 weeks
Balance
Time frame: 8 weeks
Postural stability (Overall Stability Index)
Time frame: 8 weeks
Postural stability (Anterior-Posterior Index)
Time frame: 8 weeks
Postural stability (Mediolateral Index)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
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 muscle training and Conventional physical therapy in people with Burn, run by Cairo 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 12 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nesma M Allam, PhD (01281968332, dr.nesma2011@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (Maximum Inspiratory Pressure) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.