Investigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity
- Conditions
- Burns
- Interventions
- Other: 2nd group- Standard physiotherapy + bicycle ergometerOther: 3rd group- Standard physiotherapy + exercise protocol to be developedOther: Control Group/1st group ( standard physiotherapy
- Registration Number
- NCT04663113
- Lead Sponsor
- Hasan Kalyoncu University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Conscious patients Enterally fed >18 years old
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aerobic Exercises group 2nd group- Standard physiotherapy + bicycle ergometer 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) the group in which the exercise protocol to be developed was applied 3rd group- Standard physiotherapy + exercise protocol to be developed Standard physiotherapy + exercise protocol to be developed: In addition to standard therapy, exercise will be given according to the measured basal metabolic rate of the patients. Control group Control Group/1st group ( standard physiotherapy Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
- Primary Outcome Measures
Name Time Method MRC scale ( Manaul muscle test) Each participant will be evaluated for 6 weeks. Peripheral muscle strength of the upper and lower extremities will be measured manually with the Medical Research Council (MRC) scale and the Modified Medical Research Council 4-point scale (MMRC). Shoulder abduction, elbow flexion and wrist extension of the upper extremity; If it belongs to the lower extremity, hip flexion, knee extension and ankle dorsi flexion will be measured in the in-bed high sitting position as a modified position specific to intensive care. Grading according to the MRC scale is between 0-5 for each muscle group: the total MRC score is between 0-60, and values below 48 indicate muscle weakness.
fibrinogen (to measure changes in both coagulation and fibrinolytic activity) Each participant will be evaluated for 6 weeks. blood test
physiological consumption index Each participant will be evaluated for 6 weeks. Physiological consumption index (PCI) was calculated ((walking heart rate) - (resting heart rate)) / (walking speed)\]. 1
D-dimer (To measure coagulation changes and Fibrinolytic Activity) Each participant will be evaluated for 6 weeks. blood test
6 min walking test Each participant will be evaluated for 6 weeks. The test involves asking the patient to walk the longest distance possible in a set interval of 6 min, through a walking course (corridor) preferably 30-m long. healthy subjects, the 6-min walk distance(6MWD) ranges from 400 to 700 m
prothrombin time Each participant will be evaluated for 6 weeks. blood test
platelets (to measure changes in both coagulation and fibrinolytic activity) Each participant will be evaluated for 6 weeks. blood test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hasan Kalyoncu University
🇹🇷Gaziantep, Turkey