BurnsNCT06067711
Response of Liver to 12 Weeks of Resistance Band Training Program in Burned Patients.
A study testing resistance band in people with Burns, run by Cairo University at 1 site in Egypt.
Trial summary
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Burns
- What is being tested?
- resistance band
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2023to 30 Mar 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Age range between 20-45 years.
- Male and female patients will participate in the study.
- All patients have burn with BBSA about 30% to 50%.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Cardiac diseases.
- Burn of sole of foot.
- Exposed hand or foot tendons.
- Upper or Lower limb amputation.
- History of liver diseases.
- Body mass index (BMI=kg/cm2)<30%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Response of Liver Enzymes to 12 Weeks of Resistance Band Training Program in Burned Patients.
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years.
Resistance training has been shown to reduce the risk of insulin resistance, aminotransfer¬ase levels, dyslipidemia and impaired fasting glucose and can be beneficial for glucose-lipid metabolism.
Read the detailed description
- Measurement procedures: Serum blood draws will be taken by certified technicians with the participant in a seated position. Spectrophotometry is the measurable analysis technique using electromagnetic spectra. It deals with the ranges of wavelengths such as near ultraviolet, near-infrared and visible light. A device called a spectrophotometer is used to measure the absorbance or transmittance through a liquid sample. The spectrophotometer measures a specific wavelength and it is possible to choose any wavelength in the spectrophotometer register as the double beam sends a beam through a blank reference sample and one through the sample to be measured. Normal values that will be used for patients are 0-45 IU/l for Alanine transaminase (ALT) and 0-35 IU/l for Aspartate transaminase(AST) Measurements will be taken before the treatment (pre-treatment) and after 12 weeks (post-treatment).
- Therapeutic procedures:
Resistance band for resistance training:
Resistance training will be performed for 12 weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull-down, leg press, leg extension and sit-ups using a resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by resistance training that will be done as a cir¬cuit, ending with a 5-minute cooldown. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first 3 weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the second 3 weeks. During the third 3 weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 3 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. A 90-second rest will be allowed between sets of exercises.
- Conditions
- Burns
- Being tested
- resistance band
- Keywords
- Plasma elevated liver enzymes
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance bandDevice
The program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band.
| Study group | Role | What they receive |
|---|---|---|
| Resistance band training group: | Experimental | This group includes 30 burned patients who will receive resistance training program for 12 weeks (3times/week) using resistance band in addition to their traditional physical therapy program and medical treatment. Receives: Device: resistance band |
| Control group: | No intervention | This group includes 30 burned patients who will receive only their traditional physical therapy program and medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) in blood plasma.
Liver enzymes
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start19 Nov 2023
- Primary completion10 Jan 2024
- Study completion30 Mar 2024
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
- Model description
- Resistance training will be performed during 12-weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching following by resistance training that will be done as a cir¬cuit, ending with 5-minute cool down. The 1 repetition maximum (1RM) is measured at baseline and follow¬ing the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
- Investigators
- A G Elsayed, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067711
- Sponsor's protocol ID
- P.T.REC/012/004652
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2023
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Liver Enzymes to 12 Weeks of Resistance Band Training Program in Burned Patients.
- ClinicalTrials.gov ID
- NCT06067711
- Acronym / sponsor ID
- P.T.REC/012/004652
- Conditions
- Burns
- Keywords
- Plasma elevated liver enzymes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 5 Oct 2023 (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.
Serum concentrations of alanine transaminase (ALT) and aspartate transaminase (AST) significantly increased immediately upon burn trauma and remained significantly elevated for about three years.
Resistance training has been shown to reduce the risk of insulin resistance, aminotransfer¬ase levels, dyslipidemia and impaired fasting glucose and can be beneficial for glucose-lipid metabolism.
Detailed description
- Measurement procedures: Serum blood draws will be taken by certified technicians with the participant in a seated position. Spectrophotometry is the measurable analysis technique using electromagnetic spectra. It deals with the ranges of wavelengths such as near ultraviolet, near-infrared and visible light. A device called a spectrophotometer is used to measure the absorbance or transmittance through a liquid sample. The spectrophotometer measures a specific wavelength and it is possible to choose any wavelength in the spectrophotometer register as the double beam sends a beam through a blank reference sample and one through the sample to be measured. Normal values that will be used for patients are 0-45 IU/l for Alanine transaminase (ALT) and 0-35 IU/l for Aspartate transaminase(AST) Measurements will be taken before the treatment (pre-treatment) and after 12 weeks (post-treatment).
- Therapeutic procedures:
Resistance band for resistance training:
Resistance training will be performed for 12 weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull-down, leg press, leg extension and sit-ups using a resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by resistance training that will be done as a cir¬cuit, ending with a 5-minute cooldown. The 1 repetition maximum (1RM) is measured at baseline and following the intervention. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first 3 weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the second 3 weeks. During the third 3 weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last 3 weeks, patients will do three circuits using 70% of their 1RM and repeat 10 times. A 90-second rest will be allowed between sets of exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Resistance training will be performed during 12-weeks for 3 sessions/week on non-consecutive days. The program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching following by resistance training that will be done as a cir¬cuit, ending with 5-minute cool down. The 1 repetition maximum (1RM) is measured at baseline and follow¬ing the intervention.
| Arm | Type | Receives |
|---|---|---|
| Resistance band training group: | Experimental | Device: resistance bandThis group includes 30 burned patients who will receive resistance training program for 12 weeks (3times/week) using resistance band in addition to their traditional physical therapy program and medical treatment. |
| Control group: | No intervention | –This group includes 30 burned patients who will receive only their traditional physical therapy program and medical treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 20-45 years.
- Male and female patients will participate in the study.
- All patients have burn with BBSA about 30% to 50%.
- All patients enrolled to the study will have their informed consent.
Key exclusion criteria (7 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- Cardiac diseases.
- Burn of sole of foot.
- Exposed hand or foot tendons.
- Upper or Lower limb amputation.
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 |
|---|---|---|
| resistance bandThe program will consist of six exercises: triceps press, biceps curl, lat pull down, leg press, leg extension and sit-ups using resistance band. | Device | Resistance band training group: |
Primary outcome
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) in blood plasma.
Time frame: Three months
Liver enzymes
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 2025.
- Individual participant dataSharing planned: No
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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.
A G Elsayed, PHD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance band 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 5 inclusion and 7 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 2025. 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?
Concentration of Alanine transaminase (ALT) and Aspartate transaminase(AST) in blood plasma. (time frame: Three months). 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 2025.