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Effect of Resistance Exercises on Liver Enzymes Post Burn.

Primary Purpose

Burns

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistance exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Study group

    Control group

    Arm Description

    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.

    This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.

    Outcomes

    Primary Outcome Measures

    EFFECT OF RESISTANCE EXERCISE ON LIVER ENZYMES POST BURN.
    plasma liver enzymes level (AST and ALT enzymes)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2023
    Last Updated
    February 5, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05728437
    Brief Title
    Effect of Resistance Exercises on Liver Enzymes Post Burn.
    Official Title
    Effect of Resistance Exercises in Reducing Plasma Liver Enzymes Level Post Burn.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 19, 2023 (Anticipated)
    Primary Completion Date
    April 2023 (Anticipated)
    Study Completion Date
    May 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Resistance training will be performed for 8 weeks with thrice-weekly sessions on non-consecutive 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 sandbags. Each session will last approximately 45 minutes and consist of a 5-minute warm-up with stretching followed by a resistance exercise that will be done as a circuit, 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 and second weeks, progressing to two circuits, using 60% of their 1RM and repeating 10 times for the third and fourth weeks. In the 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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    This group includes 30 burned patients who will receive their physical therapy program (splinting, stretching ex., strengthening ex. and ROM ex.) and medical treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Resistance exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    EFFECT OF RESISTANCE EXERCISE ON LIVER ENZYMES POST BURN.
    Description
    plasma liver enzymes level (AST and ALT enzymes)
    Time Frame
    Two month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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%.

    12. IPD Sharing Statement

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