Clinical trial NCT06138886: Calisthenics Exercise and Electromagnetic Therapy on Liver Function Following Burn Injuries.
Official title: Calisthenics Exercise Program and Pulsed Electromagnetic Therapy on Liver Function Following Burn Injuries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

2. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%.

Primary outcomes:
measure: Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical therapy, Cairo University
Study officials:
affiliation: Cairo University
name: A G Elsayed, PHD
role: STUDY_CHAIR
References: