Clinical trial NCT04663113: Investigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity
Official title: Investigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: physiotherapy
Burn rehabilitation
Major burns
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 30 patients, 10 patients for each group, were planned to be included in the study.

The individuals participating in the study will be divided into 3 groups: Standard therapy (1st Group), Standard therapy + bicycle ergometer (2nd Group) and Standard therapy + exercise protocol to be developed (3rd Group)
Primary purpose: TREATMENT

Brief summary: The aim of this study is; To investigate the Effect of the Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity, and to create an exercise protocol that can guide researchers working in burn patients and physiotherapists working in burn centers at national and international level.

The study, which is planned to be carried out in Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, will be included in the burn patients in the 25 Aralık State Hospital Burn Center, service and intensive care unit.

Detailed description: Burn injury is one of the longest traumas, causing serious mortality and morbidity, and the length of hospital stay and rehabilitation period.

For optimal treatment after burns, all pathophysiological changes that may occur locally and systemically after injury should be well known.

Along with surgical and medical treatments, the role of early exercise in burn treatment is becoming more and more important.

Burn patients need a long rehabilitation period, including the acute period and the post-discharge period.

Early exercise is very important, especially in burn intensive care units, for healing of burns and minimizing the effects of hypermetabolism. Exercises should be started from the first day the patient is hospitalized.

In a study on physiotherapists working in 6 major burn centers in the United States, stated that all physiotherapists applied various exercises in the early period in burn patients, but these exercises varied in all centers in terms of characteristics such as type and frequency. In the same study, it was emphasized that exercise programs, which are the biggest help in reducing intensive care periods in burn patients, should be more consistent and there is a need for studies investigating the components of the exercises.

Stated in another study that the exercise program applied in the early period in burns does not have an internationally accepted standard and studies should be done to create an exercise prescription.

In recent years, it has been emphasized that exercise protocols differ between physiotherapists and that there is no international standardization in questionnaire studies on exercise protocols applied to burn patients.

In addition, it has been emphasized that studies investigating exercise components will contribute more to the burn literature.

The aim of this study is; To investigate the Effect of the Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity, and to create an exercise protocol that can guide researchers working in burn patients and physiotherapists working in burn centers at national and international level.

The study, which is planned to be carried out in Hasan Kalyoncu University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, will be included in the burn patients in the 25 Aralık State Hospital Burn Center, service and intensive care unit.

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
* prothrombin time\> 14.6 sec A total of 30 patients, 10 patients for each group, were planned to be included in the study.

The individuals participating in the study will be divided into 3 groups: Standard therapy (1st Group), Standard therapy + bicycle ergometer (2nd Group) and Standard therapy + exercise protocol to be developed (3rd Group)

Assessment of Coagulation and Fibrinolytic Activity

Prothrombin time Platelet D-dimer, Fibrinogen

These parameters will be monitored 3 days a week for 6 weeks (These parameters will be monitored 3 days a week for 6 weeks (These biochemistry parameters are routinely checked in every patient at the 25 December State Hospital Burn Center)

Evaluation of Functional Capacity 6 min walking test Physiological consumption index MRC scale (general muscle strength measurement scale used in intensive care patients)

These parameters will be monitored weekly (once a week) for 6 weeks.

Evaluation of Basal Metabolism

For basal metabolism, "hand held device" indirect calorimeter will be used and individuals in each group will be evaluated and monitored daily.

Eligibility 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

Primary outcomes:
measure: D-dimer (To measure coagulation changes and Fibrinolytic Activity)
timeFrame: Each participant will be evaluated for 6 weeks.
measure: fibrinogen (to measure changes in both coagulation and fibrinolytic activity)
timeFrame: Each participant will be evaluated for 6 weeks.
measure: prothrombin time
timeFrame: Each participant will be evaluated for 6 weeks.
measure: platelets (to measure changes in both coagulation and fibrinolytic activity)
timeFrame: Each participant will be evaluated for 6 weeks.
measure: 6 min walking test
timeFrame: Each participant will be evaluated for 6 weeks.
measure: physiological consumption index
timeFrame: Each participant will be evaluated for 6 weeks.
measure: MRC scale ( Manaul muscle test)
timeFrame: Each participant will be evaluated for 6 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Murat A ÇINAR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veldema J, Bosl K, Kugler P, Ponfick M, Gdynia HJ, Nowak DA. Cycle ergometer training vs resistance training in ICU-acquired weakness. Acta Neurol Scand. 2019 Jul;140(1):62-71. doi: 10.1111/ane.13102. Epub 2019 May 10.
citation: Keck M, Herndon DH, Kamolz LP, Frey M, Jeschke MG. Pathophysiology of burns. Wien Med Wochenschr. 2009;159(13-14):327-36. doi: 10.1007/s10354-009-0651-2.
citation: Serghiou M, Cowan A, Whitehead C. Rehabilitation after a burn injury. Clin Plast Surg. 2009 Oct;36(4):675-86. doi: 10.1016/j.cps.2009.05.008.
citation: Brusselaers N, Monstrey S, Vogelaers D, Hoste E, Blot S. Severe burn injury in Europe: a systematic review of the incidence, etiology, morbidity, and mortality. Crit Care. 2010;14(5):R188. doi: 10.1186/cc9300. Epub 2010 Oct 19.
citation: 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.
citation: Glas GJ, Levi M, Schultz MJ. Coagulopathy and its management in patients with severe burns. J Thromb Haemost. 2016 May;14(5):865-74. doi: 10.1111/jth.13283. Epub 2016 Mar 23.
citation: 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.