BurnsNCT06013553
The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study
A study testing Aerobic Exercises group in people with Burns and Physiotherapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns, Physiotherapy, Aerobic Exercises
- What is being tested?
- Aerobic Exercises group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious patients Enterally fed >18 years old
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hasan Kalyoncu University
Gaziantep, 27000
MURAT A ÇINAR, DR, 05331639319, muratalicinar@gmail.com
About this study
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.
Read the 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.
- Conditions
- Burns, Physiotherapy, Aerobic Exercises
- Being tested
- Control Group, Aerobic Exercises group
- Keywords
- burns,, neutrophil lymphocyte ratio, Platelet-Lymphocyte ratio, Lymphocyte Monocyte ratio
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
Aerobic Exercises groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: Aerobic Exercises group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil lymphocyte ratio
blood test
Measured: Each participant will be evaluated for 6 weeks
Platelet-Lymphocyte ratio
blood test
Measured: Each participant will be evaluated for 6 weeks
Lymphocyte Monocyte ratio
blood test
Measured: Each participant will be evaluated for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Aug 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ali ÇINAR, Hasan Kalyoncu University
- Investigators
- MURAT A ÇINAR, DR, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013553
- Sponsor's protocol ID
- MAC2023
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32054846Romero 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.
PubMed 31433672Nielson 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.
PubMed 27183443Cinar 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.
PubMed 31475319Flores 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.
PubMed 31864784Cinar 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.
PubMed 38936330
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06013553
- Acronym / sponsor ID
- MAC2023
- Conditions
- Burns, Physiotherapy, Aerobic Exercises
- Keywords
- burns,, neutrophil lymphocyte ratio, Platelet-Lymphocyte ratio, Lymphocyte Monocyte ratio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Control GroupStandard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises. |
| Experimental: Aerobic Exercises group | Experimental | Other: Aerobic Exercises groupAerobic 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Conscious patients Enterally fed >18 years old
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupIt comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises. | Other | control group |
| Aerobic Exercises groupStandard 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 | Other | Experimental: Aerobic Exercises group |
Primary outcome
Neutrophil lymphocyte ratio
Time frame: Each participant will be evaluated for 6 weeks
blood test
Platelet-Lymphocyte ratio
Time frame: Each participant will be evaluated for 6 weeks
blood test
Lymphocyte Monocyte ratio
Time frame: Each participant will be evaluated for 6 weeks
blood test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Results publication: PubMed 32054846Jeschke 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.
- Results publication: PubMed 31433672Romero 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.
- Results publication: PubMed 27183443Nielson 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.
- Results publication: PubMed 31475319Cinar 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.
- Results publication: PubMed 31864784Flores 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.
- Derived from this study: PubMed 38936330Cinar 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.
- Individual participant dataSharing planned: No
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MURAT A ÇINAR, DR principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercises group in people with Burns and Physiotherapy, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MURAT A ÇINAR, DR (+905331639319, muratalicinar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil lymphocyte ratio (time frame: Each participant will be evaluated for 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06013553, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.