Calisthenics Exercise and Electromagnetic Therapy on Liver Function Following Burn Injuries.

November 14, 2023 updated by: Aya Gamal Fawzy El-Sayed, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 3387722
        • Recruiting
        • Faculty of physical therapy, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calisthenics exercise group
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.
Device: Pulsed electromagnetic therapy group
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.
Other Names:
  • Calisthenics exercise
Experimental: Pulsed electromagnetic therapy group
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.
Device: Pulsed electromagnetic therapy group
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.
Other Names:
  • Calisthenics exercise
Experimental: Calisthenics exercises and pulsed electromagnetic therapy group
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.
Device: Pulsed electromagnetic therapy group
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.
Other Names:
  • Calisthenics exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma.
Time Frame: Three months
Liver enzymes
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: A G Elsayed, PHD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2023

Primary Completion (Estimated)

February 14, 2024

Study Completion (Estimated)

May 14, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

November 14, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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