Clinical trial NCT06067711: Response of Liver to 12 Weeks of Resistance Band Training Program in Burned Patients.
Official title: Response of Liver Enzymes to 12 Weeks of Resistance Band Training Program in Burned Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Resistance training will be performed during 12-weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching following by resistance training that will be done as a cir¬cuit, ending with 5-minute cool down. The 1 repetition maximum (1RM) is measured at baseline and follow¬ing the intervention.
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.

Resistance training has been shown to reduce the risk of insulin resistance, aminotransfer¬ase levels, dyslipidemia and impaired fasting glucose and can be beneficial for glucose-lipid metabolism.

Detailed description: 1. 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 12 weeks (post-treatment).
2. Therapeutic procedures:

Resistance band for resistance training:

Resistance training will be performed for 12 weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull-down, leg press, leg extension and sit-ups using a resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by resistance training that will be done as a cir¬cuit, ending with a 5-minute cooldown. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first 3 weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the second 3 weeks. During the third 3 weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 3 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. A 90-second rest will be allowed between sets of exercises.

Eligibility criteria: Inclusion Criteria:

The subject selection will be according to the following criteria:

* Age range between 20-45 years.
* Male and female patients will participate in the study.
* All patients have burn with BBSA about 30% to 50%.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* The potential participants will be excluded if they meet one of the following criteria:
* Cardiac diseases.
* Burn of 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) 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: