Insulin Resistance and Resisted Exercise Post Burn
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 主要终点
- 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.
研究概览
简要总结
The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
结局指标
主要结局
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.
时间窗: 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
次要结局
未报告次要终点
研究者
Mahmoud Saeed Abd El Aziz Gobara
doctor
Cairo University