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CompletedNCT04365296Updated Apr 28, 2020

Aerobic Versus Resistance Exercises on Liver Enzymes Following Burn Injuries

An interventional study of Experimental in Burns, sponsored by Aya Gamal Fawzy El-Sayed. Completed at 1 site in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by Aya Gamal Fawzy El-Sayed · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Burns

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03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 524 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

This is the only study on the registry with Aya Gamal Fawzy El-Sayed as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • -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.

Exclusion criteria

Exclusion Criteria:

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%.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Aerobic group

    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).

    Other: Experimental

  • Experimental
    Resistance group

    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).

    Other: Experimental

Interventions

  • OtherExperimental

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 2 months

07

Study locations

1 site
  • Orabi Hospital
    Cairo, 11828, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04365296
Lead sponsor
Aya Gamal Fawzy El-Sayed
Responsible party
Aya Gamal Fawzy El-Sayed (Assistant lecturer, Cairo University) — Sponsor-investigator
First posted
Apr 28, 2020
Start date
Mar 15, 2019
Primary completion
Jun 15, 2019
Completion
Mar 15, 2020
Last update
Apr 28, 2020

Study contacts

A M Abd El Baky, Prof.DR
study chair · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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