Protein Supplementation and Exercise Training in Burn Patients

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04508218
• Other study ID #: P.T.REC/012/002758
• Status: Completed
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: February 25, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 25, 2020
• Est. primary completion date: February 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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.
• traditional burn care
ROM exercises, stretching, ADL activities and scar management

Locations

Country	Name	City	State
Egypt	Nesma Morgan Allam	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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