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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Orabi Hospital

    Cairo, 11828

Other trials in Egypt

About this study

  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. 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 groups in NCT04365296
Study groupRoleWhat they receive
Aerobic groupExperimentalThis 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 groupExperimentalThis 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.

  1. 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.

  1. First posted28 Apr 2020
  2. Study start15 Mar 2019
  3. Primary completion15 Jun 2019
  4. Study completion15 Mar 2020

Resources

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)
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

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.

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