search
Back to results

Protein Supplementation and Exercise Training in Burn Patients

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
whey protein supplementation powder (Inkospor X-TREME; France)
Exercise training program
traditional burn care
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Exercise training, Protein supplementation, Muscle strength, Lean body mass, Burn

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nesma Morgan Allam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Protein+ Exercise group

Protein group

Exercise group

Control group

Arm Description

Received oral protein supplementation, exercise program and traditional burn care

Received oral protein supplementation and traditional burn care

Received exercise program and traditional burn care

Received traditional burn care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 5, 2020
Last Updated
August 7, 2020
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04508218
Brief Title
Protein Supplementation and Exercise Training in Burn Patients
Official Title
Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
February 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Exercise training, Protein supplementation, Muscle strength, Lean body mass, Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein+ Exercise group
Arm Type
Experimental
Arm Description
Received oral protein supplementation, exercise program and traditional burn care
Arm Title
Protein group
Arm Type
Experimental
Arm Description
Received oral protein supplementation and traditional burn care
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Received exercise program and traditional burn care
Arm Title
Control group
Arm Type
Other
Arm Description
Received traditional burn care
Intervention Type
Dietary Supplement
Intervention Name(s)
whey protein supplementation powder (Inkospor X-TREME; France)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Exercise training program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional burn care
Intervention Description
ROM exercises, stretching, ADL activities and scar management
Primary Outcome Measure Information:
Title
lean body mass
Description
The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM
Time Frame
after 12 week of intervention
Secondary Outcome Measure Information:
Title
muscle strength
Description
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.
Time Frame
after 12 week of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Organizational Affiliation
lecturer at faculty of physical therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nesma Morgan Allam
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
results of the study
IPD Sharing Time Frame
6 months after puplication
IPD Sharing Access Criteria
study protocol

Learn more about this trial

Protein Supplementation and Exercise Training in Burn Patients

We'll reach out to this number within 24 hrs