Insulin Resistance and Resisted Exercise Post Burn

NCT ID: NCT06654908

Last Updated: 2024-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

resisted exercise using sand bags,resistance machines and elastic bands

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Saeed Abd El Aziz Gobara

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amany Rt Abdel Wahid, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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mahmoud Sd gobara, bachelor

Role: CONTACT

800-555-5555

Hesham Gl Mahran, Professor

Role: CONTACT

+01030792492

References

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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.

Reference Type BACKGROUND
PMID: 20829185 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 33586681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12099954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24824900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20614394 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11374194/

national library of medicine , national centre of biotechnology information

Other Identifiers

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insulin and resisted exercise

Identifier Type: -

Identifier Source: org_study_id

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