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

August 22, 2023 updated by: Murat Ali ÇINAR, Hasan Kalyoncu University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

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

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27000
        • Recruiting
        • Hasan Kalyoncu University
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

-

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: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil lymphocyte ratio
Time Frame: Each participant will be evaluated for 6 weeks
blood test
Each participant will be evaluated for 6 weeks
Platelet-Lymphocyte ratio
Time Frame: Each participant will be evaluated for 6 weeks
blood test
Each participant will be evaluated for 6 weeks
Lymphocyte Monocyte ratio
Time Frame: Each participant will be evaluated for 6 weeks
blood test
Each participant will be evaluated for 6 weeks

Collaborators and Investigators

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

Sponsor

Hasan Kalyoncu University

Investigators

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

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 (Actual)

August 1, 2023

Primary Completion (Estimated)

October 15, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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