BurnsNCT06138886
Calisthenics Exercise and Electromagnetic Therapy on Liver Function Following Burn Injuries.
A study testing Pulsed electromagnetic therapy and calisthenics exercises in people with Burns, run by Cairo University at 1 site in Egypt.
Trial summary
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years. Calisthenics exercises consist of movements that increase the flexibility and strength of the body. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Burns
- What is being tested?
- Pulsed electromagnetic therapy and calisthenics exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Nov 2023to 14 May 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges between 20-45 years.
- Male and female patients will participate in the study.
- All patients have burns with BBSA about 30% to 50%
- All patients enrolled on the study will have their informed consent
Who cannot join
- Cardiac diseases.
- Burn of the sole of foot.
- Exposed hand or foot tendons.
- Upper or Lower limb amputation.
- History of liver diseases.
- Body mass index (BMI=kg/cm2)<30%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calisthenics Exercise Program and Pulsed Electromagnetic Therapy on Liver Function Following Burn Injuries.
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years.
Calisthenics exercises consist of movements that increase the flexibility and strength of the body. It is a type of exercise consisting of various movements applied without equipment and apparatus, using your body weight.
Clinical evidence shows that PEMF therapy reduces pain associated with trauma from accidents, sports injuries, surgeries and burns as well as from disease and degeneration. PEMF therapy improves these conditions in many different concurrent ways including mechanical, chemical, electrical and magnetic processes within the cells of the body.
Read the detailed description
-Measurement procedures: Serum blood draws will be taken by certified technicians with the participant in a seated position.
Spectrophotometry is the measurable analysis technique using electromagnetic spectra. It deals with the ranges of wavelengths such as near ultraviolet, near-infrared and visible light. A device called a spectrophotometer is used to measure the absorbance or transmittance through a liquid sample. The spectrophotometer measures a specific wavelength and it is possible to choose any wavelength in the spectrophotometer register as the double beam sends a beam through a blank reference sample and one through the sample to be measured.
Normal values that will be used for patients are 0-45 IU/l for Alanine transaminase (ALT) and 0-35 IU/l for Aspartate transaminase(AST).
Measurements will be taken before the treatment (pre-treatment) and after 3 months (post-treatment).
2-Therapeutic procedures: 2. a: Procedures of calisthenics exercises program: The workout schedule will last for 12 weeks with medium-intensity calisthenics exercises of 60 minutes for 3 days in a week. The intensity will be held at the pace at which the participants feel comfortable. In each workout period, after 10 minutes of warm-up, the exercises will be done in 45 minutes as pistol squat, leg raise, lunge stop, Russian twist, shoulder taps, inverse pull-up, dips, supermen exercise and crunch for 3 sets/8 repetitions and plank exercise for 3 sets/30min. Every workout will end with 5 minutes of cooling exercises.
- b: Procedures of Pulsed electromagnetic therapy: The treatment procedures will start after the patient's release from the intensive care unit.
The patient will be asked to remove metal objects or anything sensitive to the magnetic field such as chains, belts, watches, etc.… before lying on the bed. Then the patient will be in a comfortable supine lying position over the motorized bed. During application, the patient will be asked not to move and remain stable as much as possible. The appliance will be connected to electrical mains supplying 230V± 10%. The solenoids are adjusted to be over the upper abdominal area. The options of the appliance are adjusted with very low frequency (15 HZ), very low intensity (20 G) for 20 minutes, 3 sessions/week for successive 3 months
- Conditions
- Burns
- Being tested
- Pulsed electromagnetic therapy, calisthenics exercises
- Keywords
- Elevated plasma liver enzymes
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic therapyDevice
The appliance will be connected to electrical mains supplying 230V± 10%. The solenoids are adjusted to be over the upper abdominal area. The options of the appliance are adjusted with very low frequency (15 HZ), very low intensity (20 G) for 20 minutes, and 3 sessions / week for successive 3 months.
calisthenics exercisesOther
This group includes 30 burned patients who will perform calisthenics exercises program for 3 months (3times/week) in addition to their traditional physical therapy program and medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Calisthenics exercise group | Experimental | This group includes 30 burned patients who will perform calisthenics exercises program for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. Receives: Other: calisthenics exercises |
| Pulsed electromagnetic therapy group | Experimental | This group includes 30 burned patients who will receive pulsed electromagnetic therapy for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. Receives: Device: Pulsed electromagnetic therapy |
| Calisthenics exercises and pulsed electromagnetic therapy group | Experimental | This group includes 30 burned patients who will perform calisthenics exercises program and receive pulsed electromagnetic therapy for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. Receives: Device: Pulsed electromagnetic therapy; Other: calisthenics exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma.
Liver enzymes
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start14 Nov 2023
- Primary completion14 Feb 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
- Investigators
- A G Elsayed, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138886
- Sponsor's protocol ID
- P.T.REC/012/004650
- Status last verified
- Aug 2025
- First submitted
- 14 Nov 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calisthenics Exercise Program and Pulsed Electromagnetic Therapy on Liver Function Following Burn Injuries.
- ClinicalTrials.gov ID
- NCT06138886
- Acronym / sponsor ID
- P.T.REC/012/004650
- Conditions
- Burns
- Keywords
- Elevated plasma liver enzymes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 18 Nov 2023 (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.
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years.
Calisthenics exercises consist of movements that increase the flexibility and strength of the body. It is a type of exercise consisting of various movements applied without equipment and apparatus, using your body weight.
Clinical evidence shows that PEMF therapy reduces pain associated with trauma from accidents, sports injuries, surgeries and burns as well as from disease and degeneration. PEMF therapy improves these conditions in many different concurrent ways including mechanical, chemical, electrical and magnetic processes within the cells of the body.
Detailed description
-Measurement procedures: Serum blood draws will be taken by certified technicians with the participant in a seated position.
Spectrophotometry is the measurable analysis technique using electromagnetic spectra. It deals with the ranges of wavelengths such as near ultraviolet, near-infrared and visible light. A device called a spectrophotometer is used to measure the absorbance or transmittance through a liquid sample. The spectrophotometer measures a specific wavelength and it is possible to choose any wavelength in the spectrophotometer register as the double beam sends a beam through a blank reference sample and one through the sample to be measured.
Normal values that will be used for patients are 0-45 IU/l for Alanine transaminase (ALT) and 0-35 IU/l for Aspartate transaminase(AST).
Measurements will be taken before the treatment (pre-treatment) and after 3 months (post-treatment).
2-Therapeutic procedures: 2. a: Procedures of calisthenics exercises program: The workout schedule will last for 12 weeks with medium-intensity calisthenics exercises of 60 minutes for 3 days in a week. The intensity will be held at the pace at which the participants feel comfortable. In each workout period, after 10 minutes of warm-up, the exercises will be done in 45 minutes as pistol squat, leg raise, lunge stop, Russian twist, shoulder taps, inverse pull-up, dips, supermen exercise and crunch for 3 sets/8 repetitions and plank exercise for 3 sets/30min. Every workout will end with 5 minutes of cooling exercises.
- b: Procedures of Pulsed electromagnetic therapy: The treatment procedures will start after the patient's release from the intensive care unit.
The patient will be asked to remove metal objects or anything sensitive to the magnetic field such as chains, belts, watches, etc.… before lying on the bed. Then the patient will be in a comfortable supine lying position over the motorized bed. During application, the patient will be asked not to move and remain stable as much as possible. The appliance will be connected to electrical mains supplying 230V± 10%. The solenoids are adjusted to be over the upper abdominal area. The options of the appliance are adjusted with very low frequency (15 HZ), very low intensity (20 G) for 20 minutes, 3 sessions/week for successive 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calisthenics exercise group | Experimental | Other: calisthenics exercisesThis group includes 30 burned patients who will perform calisthenics exercises program for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. |
| Pulsed electromagnetic therapy group | Experimental | Device: Pulsed electromagnetic therapyThis group includes 30 burned patients who will receive pulsed electromagnetic therapy for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. |
| Calisthenics exercises and pulsed electromagnetic therapy group | Experimental | Device: Pulsed electromagnetic therapy, Other: calisthenics exercisesThis group includes 30 burned patients who will perform calisthenics exercises program and receive pulsed electromagnetic therapy for 3 months (3 times/week) in addition to their traditional physical therapy program and medical treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ranges between 20-45 years.
- Male and female patients will participate in the study.
- All patients have burns with BBSA about 30% to 50%
- All patients enrolled on the study will have their informed consent
Key exclusion criteria (6 listed)
- Cardiac diseases.
- Burn of the sole of foot.
- Exposed hand or foot tendons.
- Upper or Lower limb amputation.
- History of liver diseases.
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 |
|---|---|---|
| Pulsed electromagnetic therapyThe appliance will be connected to electrical mains supplying 230V± 10%. The solenoids are adjusted to be over the upper abdominal area. The options of the appliance are adjusted with very low frequency (15 HZ), very low intensity (20 G) for 20 minutes, and 3 sessions / week for successive 3 months. | Device | Calisthenics exercises and pulsed electromagnetic therapy group, Pulsed electromagnetic therapy group |
| calisthenics exercisesThis group includes 30 burned patients who will perform calisthenics exercises program for 3 months (3times/week) in addition to their traditional physical therapy program and medical treatment. | Other | Calisthenics exercise group, Calisthenics exercises and pulsed electromagnetic therapy group |
Primary outcome
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma.
Time frame: Three months
Liver enzymes
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
A G Elsayed, PHD study chair
Cairo 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 Pulsed electromagnetic therapy and calisthenics exercises in people with Burns, 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 6 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 11 Aug 2025. 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?
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma. (time frame: Three months). 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 11 Aug 2025.