Protein Supplementation and Exercise Training in Burn Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Dietary supplement: whey protein supplementation powder (Inkospor X-TREME; France); Other: Exercise training program; Other: traditional burn care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Nesma Morgan Allam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein+ Exercise group; Received oral protein supplementation, exercise program and traditional burn care	Dietary supplement: whey protein supplementation powder (Inkospor X-TREME; France); Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening; Other: Exercise training program; After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.; Other: traditional burn care; ROM exercises, stretching, ADL activities and scar management
Experimental: Protein group; Received oral protein supplementation and traditional burn care	Dietary supplement: whey protein supplementation powder (Inkospor X-TREME; France); Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening; Other: traditional burn care; ROM exercises, stretching, ADL activities and scar management
Experimental: Exercise group; Received exercise program and traditional burn care	Other: Exercise training program; After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.; Other: traditional burn care; ROM exercises, stretching, ADL activities and scar management
Other: Control group; Received traditional burn care	Other: traditional burn care; ROM exercises, stretching, ADL activities and scar management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lean body mass	The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM	after 12 week of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	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.	after 12 week of intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nesma M Allam, PhD, lecturer at faculty of physical therapy

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): February 2, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Exercise training; Muscle strength; Protein supplementation; Burn; Lean body mass
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: P.T.REC/012/002758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: results of the study
• IPD Sharing Time Frame: 6 months after puplication
• IPD Sharing Access Criteria: study protocol
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No