NCT06067711

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

September 28, 2023

Last Update Submit

August 6, 2025

Conditions

Keywords

Plasma elevated liver enzymes

Outcome Measures

Primary Outcomes (1)

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

    Liver enzymes

    Three months

Study Arms (2)

Resistance band training group:

EXPERIMENTAL

This group includes 30 burned patients who will receive resistance training program for 12 weeks (3times/week) using resistance band in addition to their traditional physical therapy program and medical treatment.

Device: resistance band

Control group:

NO INTERVENTION

This group includes 30 burned patients who will receive only their traditional physical therapy program and medical treatment.

Interventions

The program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band.

Resistance band training group:

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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%.

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
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy of surgery

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 5, 2023

Study Start

November 19, 2023

Primary Completion

January 10, 2024

Study Completion

March 30, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations