Effect of Resistance Exercises on Liver Enzymes Post Burn.

NCT ID: NCT05728437

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-19
• Study Completion Date: 2023-05-31

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance exercise

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Resistance exercise

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.

Intervention Type: PROCEDURE

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%.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Gamal Fawzy El-Sayed

Lecturer of physical therapy of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/003633

Identifier Type: -

Identifier Source: org_study_id