- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05728437
Effect of Resistance Exercises on Liver Enzymes Post Burn.
Effect of Resistance Exercises in Reducing Plasma Liver Enzymes Level Post Burn.
Study Overview
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.
1. Group A (Study 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.
1. Group B (Control group): This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study 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.
|
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.
|
|
No Intervention: Control group
This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EFFECT OF RESISTANCE EXERCISE ON LIVER ENZYMES POST BURN.
Time Frame: Two month
|
plasma liver enzymes level (AST and ALT enzymes)
|
Two month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003633
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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