BurnsNCT04365296
Aerobic Versus Resistance Exercises on Liver Enzymes Following Burn Injuries
A study testing Experimental in people with Burns, run by Aya Gamal Fawzy El-Sayed at 1 site in Egypt.
Trial summary
1. Subjects: Sixty patients suffering from partial thickness burn with burned body surface area (BBSA) about 30% to 50% will be randomly divided into two equal groups each one has 30 patients. 2. Equipment and tools: 2.1. Measurement equipment: Spectrophotometer device. 2.2. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Burns
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2019to 15 Mar 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 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.
- 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
- Subjects: Sixty patients suffering from partial thickness burn with burned body surface area (BBSA) about 30% to 50% will be randomly divided into two equal groups each one has 30 patients.
- Equipment and tools:
2.1. Measurement equipment: Spectrophotometer device. 2.2. Therapeutic equipment and tools: Treadmill device for aerobic exercises and dumbbells and sand bags for resistance exercises.
Read the detailed description
Sixty patients who have partial thickness burn with burned body surface area (BBSA) about 30% to 50% will participate in this study after their release from intensive care unit. Their ages will be ranged from 20 to 45 years. The participants will be selected from Orabi hospital and randomly distributed into two equal groups. In this study the patients will be randomly assigned into two equal groups (30 patients for each group):
1.1(a) Group A (Aerobic exercise group): This group includes 30 burned patients who will receive aerobic exercises 8 weeks (3times/week) in form of (treadmill device) in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.
1.1(b) Group B (Resistance exercise group): This group includes 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.
3.1-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 the 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 takes a measurement at a specific wavelength and it is possible to choose any wavelength in the spectrophotometers register as the double beam sends a beam through a blank reference sample and one through the sample to be measured (Nilsson, 2010).
3.2-Therapeutic procedures: 3.2.a- Treadmill device for aerobic exercise: During the 8-week intervention period, an aerobic training (AT) program of submaximal intensity will include a 45-minute session three times a week (135 min/week) under the supervision of the researcher. Aerobic exercise will consist of three phases: warm-up, training and cool down. At the beginning of exercise session, subjects will have a ten-minute warm-up. The warmup protocol will be slowly running on treadmill. Then, the warm-up phase will be followed by the training phase. At baseline, the training phase will be commenced with two 15-minute running on treadmill at 60% of their maximal heart rate (MHR) in the first week and increased to two 15-minute running on treadmill at 75% MHR per week by the final week of training. By the end of exercise session, subjects will have a five-minute cool down. The cool down protocol will be slowly running on treadmill (Khalighfard et al., 2011).
Maximum heart rate will be calculated using the formula: (HRMax =220- age) (Chaudhary et al., 2010).
3.2.b- Dumbbells and sand bags for resistance exercise: Resistance training will be performed during 8-weeks with thrice weekly sessions on nonconsecutive days. The program will consist of seven exercises: triceps press, biceps curl, lat pull down, calf raise, leg press, leg extension and sit-ups using dumbbells and sand bags. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching following by resistance exercise 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. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeat 10 times for the third and fourth weeks. In fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last two 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 (Hallsworth et al., 2011).
- Conditions
- Burns
- Being tested
- Experimental
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
The purpose of the study is to evaluate which is more effective aerobic or resistance exercises in reducing plasma liver enzymes level (AST and ALT) post burn. Subjects and Methods: Sixty burned patients with burned body surface area about 30% to 50% will participate in this study. Their ages will be ranged from 20-45 years. They will be selected from Orabi Hospital and will be divided randomly into two equal groups.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic group | Experimental | This group will include 30 burned patients who will receive aerobic exercises 8 weeks (3times/week) in form of treadmill exercise in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings). Receives: Other: Experimental |
| Resistance group | Experimental | This group will include 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings). Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of AST and ALT Liver enzymes post treatment
Measures of AST and ALT Liver enzymes post 8 weeks of treatment for 10 patients of Aerobic group and 10 patients of resistance group.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start15 Mar 2019
- Primary completion15 Jun 2019
- Study completion15 Mar 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.
- 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aya Gamal Fawzy El-Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Gamal Fawzy El-Sayed, Cairo University
- Investigators
- A M Abd El Baky, Prof.DR, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365296
- Sponsor's protocol ID
- P.T.REC/012/002230
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- 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 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Versus Resistance Exercises on Liver Enzymes Following Burn Injuries
- ClinicalTrials.gov ID
- NCT04365296
- Acronym / sponsor ID
- P.T.REC/012/002230
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aya Gamal Fawzy El-SayedUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 28 Apr 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.
- Subjects: Sixty patients suffering from partial thickness burn with burned body surface area (BBSA) about 30% to 50% will be randomly divided into two equal groups each one has 30 patients.
- Equipment and tools:
2.1. Measurement equipment: Spectrophotometer device. 2.2. Therapeutic equipment and tools: Treadmill device for aerobic exercises and dumbbells and sand bags for resistance exercises.
Detailed description
Sixty patients who have partial thickness burn with burned body surface area (BBSA) about 30% to 50% will participate in this study after their release from intensive care unit. Their ages will be ranged from 20 to 45 years. The participants will be selected from Orabi hospital and randomly distributed into two equal groups. In this study the patients will be randomly assigned into two equal groups (30 patients for each group):
1.1(a) Group A (Aerobic exercise group): This group includes 30 burned patients who will receive aerobic exercises 8 weeks (3times/week) in form of (treadmill device) in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.
1.1(b) Group B (Resistance exercise group): This group includes 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment.
3.1-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 the 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 takes a measurement at a specific wavelength and it is possible to choose any wavelength in the spectrophotometers register as the double beam sends a beam through a blank reference sample and one through the sample to be measured (Nilsson, 2010).
3.2-Therapeutic procedures: 3.2.a- Treadmill device for aerobic exercise: During the 8-week intervention period, an aerobic training (AT) program of submaximal intensity will include a 45-minute session three times a week (135 min/week) under the supervision of the researcher. Aerobic exercise will consist of three phases: warm-up, training and cool down. At the beginning of exercise session, subjects will have a ten-minute warm-up. The warmup protocol will be slowly running on treadmill. Then, the warm-up phase will be followed by the training phase. At baseline, the training phase will be commenced with two 15-minute running on treadmill at 60% of their maximal heart rate (MHR) in the first week and increased to two 15-minute running on treadmill at 75% MHR per week by the final week of training. By the end of exercise session, subjects will have a five-minute cool down. The cool down protocol will be slowly running on treadmill (Khalighfard et al., 2011).
Maximum heart rate will be calculated using the formula: (HRMax =220- age) (Chaudhary et al., 2010).
3.2.b- Dumbbells and sand bags for resistance exercise: Resistance training will be performed during 8-weeks with thrice weekly sessions on nonconsecutive days. The program will consist of seven exercises: triceps press, biceps curl, lat pull down, calf raise, leg press, leg extension and sit-ups using dumbbells and sand bags. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching following by resistance exercise 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. Initially, participants will do two circuits using 50% of their 1RM and repeat them 10 times for the first and second weeks, progressing to two circuits, using 60% of their 1RM and repeat 10 times for the third and fourth weeks. In fifth and sixth weeks, participants will do three circuits using 60% of their 1RM and repeat 10 times. In the last two 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 (Hallsworth et al., 2011).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic group | Experimental | Other: ExperimentalThis group will include 30 burned patients who will receive aerobic exercises 8 weeks (3times/week) in form of treadmill exercise in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings). |
| Resistance group | Experimental | Other: ExperimentalThis group will include 30 burned patients who will receive resistance exercises 8 weeks (3times/week) by using dumbbells and sand bags in addition to their physical therapy program (splinting, stretching ex. and ROM ex.) and medical treatment (medications as cataflam, alphintern, zinetac and hemacaps and wound dressings). |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- -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.
Key exclusion criteria (7 listed)
- Cardiac diseases.
- Burn of sole of foot.
- Exposed hand or foot tendons.
- Lower limb amputation.
- History of liver diseases.
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 |
|---|---|---|
| ExperimentalThe purpose of the study is to evaluate which is more effective aerobic or resistance exercises in reducing plasma liver enzymes level (AST and ALT) post burn. Subjects and Methods: Sixty burned patients with burned body surface area about 30% to 50% will participate in this study. Their ages will be ranged from 20-45 years. They will be selected from Orabi Hospital and will be divided randomly into two equal groups. | Other | Aerobic group, Resistance group |
Primary outcome
Measures of AST and ALT Liver enzymes post treatment
Time frame: 2 months
Measures of AST and ALT Liver enzymes post 8 weeks of treatment for 10 patients of Aerobic group and 10 patients of resistance group.
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 28 Apr 2020.
- 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 M Abd El Baky, Prof.DR 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 Experimental in people with Burns, run by Aya Gamal Fawzy El-Sayed 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 28 Apr 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?
Measures of AST and ALT Liver enzymes post treatment (time frame: 2 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 28 Apr 2020.