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Completed

NCT Number: NCT04508218

Protein Supplementation and Exercise Training 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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nesma Morgan Allam

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whey protein supplementation powder (Inkospor X-TREME; France)

Dietary Supplement

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

Exercise training program

Other

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.

traditional burn care

Other

ROM exercises, stretching, ADL activities and scar management

Primary outcomes

  1. 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

  1. muscle strength

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 11, 2020
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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