BurnsNCT04508218
Protein Supplementation and Exercise Training in Burn Patients
A study testing whey protein supplementation powder (Inkospor X-TREME; France), Exercise training program and traditional burn care in people with Burns, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- whey protein supplementation powder (Inkospor X-TREME; France), Exercise training program and traditional burn care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2019to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength 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.
Read the 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.
- Conditions
- Burns
- Being tested
- whey protein supplementation powder (Inkospor X-TREME; France), Exercise training program, traditional burn care
- Keywords
- Exercise training, Protein supplementation, Muscle strength, Lean body mass, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 programOther
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 careOther
ROM exercises, stretching, ADL activities and scar management
| Study group | Role | What they receive |
|---|---|---|
| Protein+ Exercise group | Experimental | Received oral protein supplementation, exercise program and traditional burn care Receives: Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France); Other: Exercise training program; Other: traditional burn care |
| Protein group | Experimental | Received oral protein supplementation and traditional burn care Receives: Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France); Other: traditional burn care |
| Exercise group | Experimental | Received exercise program and traditional burn care Receives: Other: Exercise training program; Other: traditional burn care |
| Control group | Other | Received traditional burn care Receives: Other: traditional burn care |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean body mass
The QDR 4500A densitometry system DXA (Hologic Inc., Bedford, USA) was used according to the manufacturer instructions for calculating LBM
Measured: after 12 week of intervention
Secondary outcomes (1)
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.
Measured: after 12 week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Aug 2019
- Primary completion2 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Nesma M Allam, PhD, Principal investigator, lecturer at faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508218
- Sponsor's protocol ID
- P.T.REC/012/002758
- Status last verified
- Aug 2020
- First submitted
- 5 Aug 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: results of the study
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Protein Supplementation to Exercise Training on Lean Body Mass and Muscle Strength in Burn Patients
- ClinicalTrials.gov ID
- NCT04508218
- Acronym / sponsor ID
- P.T.REC/012/002758
- Conditions
- Burns
- Keywords
- Exercise training, Protein supplementation, Muscle strength, Lean body mass, Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Protein+ Exercise group | Experimental | Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France), Other: Exercise training program, Other: traditional burn careReceived oral protein supplementation, exercise program and traditional burn care |
| Protein group | Experimental | Dietary Supplement: whey protein supplementation powder (Inkospor X-TREME; France), Other: traditional burn careReceived oral protein supplementation and traditional burn care |
| Exercise group | Experimental | Other: Exercise training program, Other: traditional burn careReceived exercise program and traditional burn care |
| Control group | Other | Other: traditional burn careReceived traditional burn care |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Protein group, Protein+ Exercise group |
| Exercise training programAfter 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 | Exercise group, Protein+ Exercise group |
| traditional burn careROM exercises, stretching, ADL activities and scar management | Other | Control group, Exercise group, Protein group, Protein+ Exercise group |
Primary outcome
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
1 secondary outcome
muscle strength
Time frame: after 12 week of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: Yes. results of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesma M Allam, PhD principal investigator
lecturer at faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whey protein supplementation powder (Inkospor X-TREME; France), Exercise training program and traditional burn care in people with Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lean body mass (time frame: after 12 week of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.