Protein Supplementation and Exercise Training in Burn Patients

Not Applicable

Completed

• Conditions: Burns
• Interventions: Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France); Other: Exercise training program; Other: traditional burn care

• Registration Number: NCT04508218
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2019-08-15
• Primary Completion: 2020-02-02
• Study Completion: 2020-02-25
• Status Verified: 2020-08
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein+ Exercise group	Exercise training program	Received oral protein supplementation, exercise program and traditional burn care
Protein+ Exercise group	traditional burn care	Received oral protein supplementation, exercise program and traditional burn care
Protein+ Exercise group	whey protein supplementation powder (Inkospor X-TREME; France)	Received oral protein supplementation, exercise program and traditional burn care
Control group	traditional burn care	Received traditional burn care
Exercise group	traditional burn care	Received exercise program and traditional burn care
Protein group	whey protein supplementation powder (Inkospor X-TREME; France)	Received oral protein supplementation and traditional burn care
Protein group	traditional burn care	Received oral protein supplementation and traditional burn care
Exercise group	Exercise training program	Received exercise program and traditional burn care

Primary Outcome Measures

Name	Time	Method
lean body mass	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 Outcome Measures

Name	Time	Method
muscle strength	after 12 week of intervention	The Biodex 3 Dynamometer Medical System (Shirley, USA) was utilized for strength assessment of quadriceps muscle of the dominant leg (concentric test) of the participants. It was performed according to manufacturer instructions.

Trial Locations

Locations (1)

Nesma Morgan Allam; 🇪🇬 Tanta, Egypt