NCT04365296

Brief Summary

  1. 1.Subjects:
  2. 2.Equipment and tools:

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 Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 23, 2020

Last Update Submit

April 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measures of AST and ALT Liver enzymes post treatment

    Measures of AST and ALT Liver enzymes post 8 weeks of treatment for 10 patients of Aerobic group and 10 patients of resistance group.

    2 months

Study Arms (2)

Aerobic group

EXPERIMENTAL

This group will include 30 burned patients who will receive aerobic exercises 8 weeks (3times/week) in form of treadmill exercise in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings).

Other: Experimental

Resistance group

EXPERIMENTAL

This group will include 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings).

Other: Experimental

Interventions

The purpose of the study is to evaluate which is more effective aerobic or resistance exercises in reducing plasma liver enzymes level (AST and ALT) post burn. Subjects and Methods: Sixty burned patients with burned body surface area about 30% to 50% will participate in this study. Their ages will be ranged from 20-45 years. They will be selected from Orabi Hospital and will be divided randomly into two equal groups.

Aerobic groupResistance 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.
  • 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)

Orabi Hospital

Cairo, 11828, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • A M Abd El Baky, Prof.DR

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

March 15, 2019

Primary Completion

June 15, 2019

Study Completion

March 15, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations