Protein Supplementation and Exercise Training in Burn Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2020-02-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Protein+ Exercise group

Received oral protein supplementation, exercise program and traditional burn care

Group Type EXPERIMENTAL

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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

ROM exercises, stretching, ADL activities and scar management

Protein group

Received oral protein supplementation and traditional burn care

Group Type EXPERIMENTAL

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

Intervention Type 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

traditional burn care

Intervention Type OTHER

ROM exercises, stretching, ADL activities and scar management

Exercise group

Received exercise program and traditional burn care

Group Type EXPERIMENTAL

Exercise training program

Intervention Type 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

Intervention Type OTHER

ROM exercises, stretching, ADL activities and scar management

Control group

Received traditional burn care

Group Type OTHER

traditional burn care

Intervention Type OTHER

ROM exercises, stretching, ADL activities and scar management

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

traditional burn care

ROM exercises, stretching, ADL activities and scar management

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes