Insulin Resistance and Resisted Exercise Post Burn

NCT06654908 | Not Yet Recruiting

• 1 other identifier: insulin and resisted exercise
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insulin Resistance

Outcome Measures

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.

  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

Study Arms (2)

Group A: (Study group) who have insulin resistance and who will receive resisted exercise

EXPERIMENTAL

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

Group B: (Control group) who have insulin resistance and who will receive routine medical treatment.

NO INTERVENTION

This group includes 34 patients who have insulin resistance and who will receive routine medical treatment.

Interventions

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 \&lt;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

Group A: (Study group) who have insulin resistance and who will receive resisted exercise

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (5)

• Levy-Marchal C, Arslanian S, Cutfield W, Sinaiko A, Druet C, Marcovecchio ML, Chiarelli F; ESPE-LWPES-ISPAD-APPES-APEG-SLEP-JSPE; Insulin Resistance in Children Consensus Conference Group. Insulin resistance in children: consensus, perspective, and future directions. J Clin Endocrinol Metab. 2010 Dec;95(12):5189-98. doi: 10.1210/jc.2010-1047. Epub 2010 Sep 8.

  PMID: 20829185 BACKGROUND

• Angelidi AM, Filippaios A, Mantzoros CS. Severe insulin resistance syndromes. J Clin Invest. 2021 Feb 15;131(4):e142245. doi: 10.1172/JCI142245.

  PMID: 33586681 BACKGROUND

• Wallace TM, Matthews DR. The assessment of insulin resistance in man. Diabet Med. 2002 Jul;19(7):527-34. doi: 10.1046/j.1464-5491.2002.00745.x.

  PMID: 12099954 BACKGROUND

• Hardee JP, Porter C, Sidossis LS, Borsheim E, Carson JA, Herndon DN, Suman OE. Early rehabilitative exercise training in the recovery from pediatric burn. Med Sci Sports Exerc. 2014 Sep;46(9):1710-6. doi: 10.1249/MSS.0000000000000296.

  PMID: 24824900 BACKGROUND

• Lippi G, Ippolito L, Cervellin G. Disseminated intravascular coagulation in burn injury. Semin Thromb Hemost. 2010 Jun;36(4):429-36. doi: 10.1055/s-0030-1254051. Epub 2010 Jul 7.

  PMID: 20614394 BACKGROUND

Related Links

• national library of medicine , national centre of biotechnology information

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Amany Rt Abdel Wahid, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmoud Sd gobara, bachelor

CONTACT

800-555-5555; mahmoudgobara14@gmail.com

Hesham Gl Mahran, Professor

CONTACT

+01030792492; heshammahran75@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 23, 2024
• Study Start: October 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: November 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10