Study Results
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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NOT_YET_RECRUITING
NA
64 participants
INTERVENTIONAL
2024-10-15
2025-11-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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
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
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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
35 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mahmoud Saeed Abd El Aziz Gobara
doctor
Principal Investigators
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Amany Rt Abdel Wahid, lecturer
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Central Contacts
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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.
Angelidi AM, Filippaios A, Mantzoros CS. Severe insulin resistance syndromes. J Clin Invest. 2021 Feb 15;131(4):e142245. doi: 10.1172/JCI142245.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Related Links
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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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