Insulin Resistance and Resisted Exercise Post Burn

Not Applicable

Not yet recruiting

• Conditions: Insulin Resistance

• Registration Number: NCT06654908
• Lead Sponsor: Cairo University

Brief Summary

The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.

Detailed Description

A burn injury represents the fourth most common type of trauma globally, though it is associated with the most devastating consequences. Severe burn injuries, encompassing 20% of the total body surface area (TBSA) in adults, present a unique challenge compared with other forms of trauma given the magnitude and persistence of systemic deregulation. Indeed, an extensive inflammatory response develops immediately following a severe burn to promote wound healing. This period, known as the "ebb" phase, is comparable with a fight-or-flight response and lasts for the first 72-96 h post injury .

Moreover, burn-induced muscle catabolism places a significant burden on the recovery process, as a 10%-30% loss impairs immune responses and delays wound healing, thereby increasing the risk of infection, and a 40% loss becomes fatal. Despite a mountainous effort to prevent muscle catabolism and wasting. Therefore, a better understanding of the pathophysiology and consequences of burn-induced skeletal muscle wasting is pivotal to alleviating hyper metabolism and reducing morbidity and mortality patients with severe burns .

Hence, extensive burn injury produce clinical syndromes characterized in part by "insulin resistance, it is unclear if these insulin resistant states are identical. To test if the maximal biological effectiveness of insulin is altered in burned patients

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study Start: 2024-10-15
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-10-15
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients ranged from 18-35 years of age.
• Patients has waist hip ratio around 0.8 in female and 0.95 in male.
• Patient has body mass index (BMI around 25 kg/m2) (J Obes Weight Loss Ther ,2015).
• Patients has second degree thermal burn injury (superficial and deep partial thickness).
• Patients with around (20% - 40%) of total body surface area (TBSA) burned.
• Patients who are able to follow verbal commands.
• Patients will have upper limb and trunk burn.
• Patients with normal hemoglobin A1C (5.6 %).
• Patients should take diet rich protein, omega 3 and should have good sleep.
• Patients passed two months post severe burns

Exclusion Criteria

• • Potential participants were excluded if they reported a leg amputation, anoxic brain injury, psychological disorders, quadriplegia, or severe behavior or cognitive disorders history of heart disease, stroke, diabetes mellitus, or any condition that would prevent them from engaging in an exercise study.
• Patients with liver disease, pancreatic disease or any disease affects metabolism.
• If they were already engaging in 2 or more planned exercise sessions per week.
• Patients with any medication to lower glucose levels. Blood pressure and medications to lower lipid levels

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the outcome of resisted exercises on the improvement of HOMA-IR test results for patients who have around (20% - 40%) of total body surface area (TBSA) burned.	baseline	sixty-eight patients, who have upper limb and trunk burn. Their ages will be ranged from 18-35 year old. Only patients around (20% - 40%) of total body surface area (TBSA) burned. The participants will be selected from government hospitals (General and insurance hospitals) and randomly distributed into 2 equal groups (group A, group B).; HOMA-IR analysis measurements: All measurements will be taken before the treatment program, 6 weeks after the beginning of treatment program and 12 weeks after the beginning of the treatment program.; Assessment of insulin resistance: • By doing HOMA-IR analysis. HOMA-IR test was performed for both groups before the treatment program, after the 6 weeks of the treatment program and after 12 weeks of the treatment program to evaluate the progression of insulin resistance in both groups.; The HOMA score of \<1.9 was considered as indicator of "Insulin sensitivity"; 1.9 to 2.9 as indicator of "Low IR" and \>2.9 as indicator of Significant IR