Insulin Resistance and Resisted Exercise Post Burn

October 21, 2024 updated by: Mahmoud Saeed Abd El Aziz Gobara, Cairo University
The main objective of the present study is to assess the effect of the resisted exercise on insulin resistance post burn.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: (Study group) who have insulin resistance and who will receive resisted exercise
This group includes 34 patients who have insulin resistance and who will receive resisted exercise
Procedure: resisted exercise using sand bags,resistance machines and elastic bands
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
No Intervention: Group B: (Control group) who have insulin resistance and who will receive routine medical treatment.
This group includes 34 patients who have insulin resistance and who will receive routine medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Amany Rt Abdel Wahid, lecturer, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • insulin and resisted exercise

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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