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Clinical Trials/NCT04508218
NCT04508218
Completed
Not Applicable

Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients

Cairo University1 site in 1 country60 target enrollmentAugust 15, 2019
ConditionsBurns

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burns
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
lean body mass
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.

Detailed Description

Sixty participants with severe burn \> 30% total body surface area (TBSA) were randomly distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise group) received oral protein supplementation, exercise program and traditional burn care, group B (Protein group) received oral protein supplementation and traditional burn care, group C (Exercise group) received exercise program and traditional burn care, group D (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System before treatment and 12 weeks after treatment.

Registry
clinicaltrials.gov
Start Date
August 15, 2019
End Date
February 25, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nesma Morgan Allam

Lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • healed deep partial-thickness thermal burn
  • \> 30% of TBSA and
  • the exercise program started after healing of the burn (after burn injury by 6 weeks)

Exclusion Criteria

  • conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,
  • presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)
  • food intolerance to milk protein products.

Outcomes

Primary Outcomes

lean body mass

Time Frame: after 12 week of intervention

The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM

Secondary Outcomes

  • muscle strength(after 12 week of intervention)

Study Sites (1)

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