Protein Supplementation and Exercise Training in Burn Patients

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04508218
Collaborator
(none)
60
1
4
6.4
9.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France)
  • Other: Exercise training program
  • Other: traditional burn care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients
Actual Study Start Date :
Aug 15, 2019
Actual Primary Completion Date :
Feb 2, 2020
Actual Study Completion Date :
Feb 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nesma Morgan Allam Tanta Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Nesma M Allam, PhD, lecturer at faculty of physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nesma Morgan Allam, Lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT04508218
Other Study ID Numbers:
  • P.T.REC/012/002758
First Posted:
Aug 11, 2020
Last Update Posted:
Aug 11, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nesma Morgan Allam, Lecturer, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2020