NCT06013553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 22, 2023

Last Update Submit

August 22, 2023

Conditions

Keywords

burns,neutrophil lymphocyte ratioPlatelet-Lymphocyte ratioLymphocyte Monocyte ratio

Outcome Measures

Primary Outcomes (3)

  • Neutrophil lymphocyte ratio

    blood test

    Each participant will be evaluated for 6 weeks

  • Platelet-Lymphocyte ratio

    blood test

    Each participant will be evaluated for 6 weeks

  • Lymphocyte Monocyte ratio

    blood test

    Each participant will be evaluated for 6 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Experimental: Aerobic Exercises group

EXPERIMENTAL

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

Interventions

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

control 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

Experimental: Aerobic Exercises group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conscious patients Enterally fed \>18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.

  • Romero SA, Moralez G, Jaffery MF, Huang M, Cramer MN, Romain N, Kouda K, Haller RG, Crandall CG. Progressive exercise training improves maximal aerobic capacity in individuals with well-healed burn injuries. Am J Physiol Regul Integr Comp Physiol. 2019 Oct 1;317(4):R563-R570. doi: 10.1152/ajpregu.00201.2019. Epub 2019 Aug 21.

  • Nielson CB, Duethman NC, Howard JM, Moncure M, Wood JG. Burns: Pathophysiology of Systemic Complications and Current Management. J Burn Care Res. 2017 Jan/Feb;38(1):e469-e481. doi: 10.1097/BCR.0000000000000355.

  • Cinar MA, Bayramlar K, Erkilic A, Gunes A, Yakut Y. The effects of early physiotherapy on biochemical parameters in major burn patients: A burn center's experience. Ulus Travma Acil Cerrahi Derg. 2019 Sep;25(5):461-466. doi: 10.5505/tjtes.2018.05950.

  • Flores O, Tyack Z, Stockton K, Paratz JD. The use of exercise in burns rehabilitation: A worldwide survey of practice. Burns. 2020 Mar;46(2):322-332. doi: 10.1016/j.burns.2019.02.016. Epub 2019 Dec 18.

  • Cinar MA, Erkilic A. Effect of aerobic exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, and lymphocyte-monocyte ratio in burn patients: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2024 Aug;95:199-206. doi: 10.1016/j.bjps.2024.05.032. Epub 2024 Jun 5.

MeSH Terms

Conditions

Burns

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • MURAT A ÇINAR, DR

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MURAT A ÇINAR, DR

CONTACT

Ahmet ERKILIÇ, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistive professor

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

August 1, 2023

Primary Completion

October 15, 2023

Study Completion

October 30, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations