The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06013553
Collaborator
(none)
30
1
2
3
10.1

Study Details

Study Description

Brief Summary

In the study, it was planned to investigate the Effect on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in burn patients by creating 2 different exercise groups. The aim of this study is to investigate the effect of aerobic exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios in burn patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Control Group
  • Other: Aerobic Exercises group
N/A

Detailed Description

Burn injuries are a trauma that is seen due to causes such as flame, hot liquid, radiation, chemical, cold or electricity and causes destruction in the skin and/or organic tissues due to energy transfer.

Burn injuries cause profound hypermetabolic and catabolic responses that can last for months or even years. Especially in burn patients with involvement of more than 20% of the total body surface area (TVSA), lipolysis, proteolysis, glycolysis, and hyperdynamic and high fever, Many severe hypermetabolic responses are seen. These hypermetabolic responses seen in patients lead to decrease in lean muscle mass, inflammation, deterioration of cardiovascular, endocrine and glucose systems, coagulopathy, deterioration of fibrinolytic activity, decrease in functional capacity, delay in wound healing, weakening of the immune system and serious mortality.

In severely burned patients, the resting metabolic rate may exceed 140% of normal.

Various parameters are used to monitor all these systemic responses of the burn. Various scores have been developed in the clinic, especially using inflammatory cells such as neutrophils, monocytes, lymphocytes and platelets. In the literature, major diseases such as cancer, heart diseases and burns It has been stated that a systemic inflammation occurs due to trauma and calculations of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte ratios are prognostic indicators.

Exercise in burn patients; It is a highly effective method with high evidence value in minimizing the effects of the hypermetabolic response caused by the burn, preventing muscle atrophy, increasing the pulmonary function and functional capacity, reducing the inflammatory response and healing the burn.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.

Other: Control Group
It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.

Experimental: Experimental: Aerobic Exercises group

Aerobic exercise will be given with bicycle ergometer in addition to Standard physiotherapy (It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises)

Other: Aerobic Exercises group
Standard physiotherapy + bicycle ergometer: In addition to the standard therapy, a bicycle ergometer for 20 minutes 5 days a week will be given. Patients will turn the pedals of the bicycle while sitting on the edge of the bed. In this protocol, a portable bicycle with adjustable pedal system, which can be placed on the edge of the bed, will be used. "Ratings of perceived exertion (RPE)" will be used to determine the intensity of aerobic activity. According to the RPE, 10-12 strength exercises will be given

Outcome Measures

Primary Outcome Measures

  1. Neutrophil lymphocyte ratio [Each participant will be evaluated for 6 weeks]

    blood test

  2. Platelet-Lymphocyte ratio [Each participant will be evaluated for 6 weeks]

    blood test

  3. Lymphocyte Monocyte ratio [Each participant will be evaluated for 6 weeks]

    blood test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Inclusion Criteria:

Conscious patients Enterally fed >18 years old

Exclusion Criteria:

With inhalation burn In addition to existing burn trauma, those with other trauma (fracture, loss of limb, etc.) Organ dysfunctions or multiple organ failure History of chronic diseases such as diabetes, cholesterol and blood pressure

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Contacts and Locations

Locations

Site City State Country Postal Code
1 Hasan Kalyoncu University Gaziantep Turkey 27000

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

  • Principal Investigator: MURAT A ÇINAR, DR, Hasan Kalyoncu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Murat Ali ÇINAR, assistive professor, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT06013553
Other Study ID Numbers:
  • MAC2023
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Murat Ali ÇINAR, assistive professor, Hasan Kalyoncu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023