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NCT Number: NCT06654908

Insulin Resistance and Resisted Exercise Post Burn

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resisted exercise using sand bags,resistance machines and elastic bands

Procedure

Rehabilitative exercise training will be performed as previously described. All exercises will be performed using free weights, elastic bands and variable-resistance machines. Modifications to exercises will be made when appropriate depending on the patient injury characteristics. The load will be gradually increased from 50-60% of 3RM at the beginning of the program up to 80-85% of 3RM (repetitions maximum) at the end of the program. All exercise sessions will be preceded by a 5-minute warm-up at <50% VO2peak. No strength training activities will be permitted outside the supervised training session; however, both groups will be encouraged to maintain normal daily activities

Primary outcomes

  1. 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.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hesham Gl Mahran, Professor

CONTACT

[email protected]

+01030792492

mahmoud Sd gobara, bachelor

CONTACT

[email protected]

800-555-5555

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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