NCT06138886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2024

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

November 14, 2023

Last Update Submit

August 6, 2025

Conditions

Burns

Keywords

Elevated plasma liver enzymes

Outcome Measures

Primary Outcomes (1)

  • Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) enzymes in blood plasma.

    Liver enzymes

    Three months

Study Arms (3)

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.

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.

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.

Device: Pulsed electromagnetic therapyOther: calisthenics exercises

Interventions

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 exercises and pulsed electromagnetic therapy groupPulsed electromagnetic therapy group
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.

Calisthenics exercise groupCalisthenics exercises and pulsed electromagnetic therapy group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical therapy, Cairo University

Giza, 3387722, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • A G Elsayed, PHD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy of surgery

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

November 14, 2023

Primary Completion

February 14, 2024

Study Completion

May 14, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)