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Investigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control Group/1st group ( standard physiotherapy
2nd group- Standard physiotherapy + bicycle ergometer
3rd group- Standard physiotherapy + exercise protocol to be developed
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring physiotherapy, Burn rehabilitation, Major burns

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasan Kalyoncu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Control group

Aerobic Exercises group

the group in which the exercise protocol to be developed was applied

Arm Description

Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.

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)

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.

Outcomes

Primary Outcome Measures

D-dimer (To measure coagulation changes and Fibrinolytic Activity)
blood test
fibrinogen (to measure changes in both coagulation and fibrinolytic activity)
blood test
prothrombin time
blood test
platelets (to measure changes in both coagulation and fibrinolytic activity)
blood test
6 min walking test
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
physiological consumption index
Physiological consumption index (PCI) was calculated ((walking heart rate) - (resting heart rate)) / (walking speed)]. 1
MRC scale ( Manaul muscle test)
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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
April 10, 2022
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT04663113
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
physiotherapy, Burn rehabilitation, Major burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
Arm Title
Aerobic Exercises group
Arm Type
Experimental
Arm Description
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)
Arm Title
the group in which the exercise protocol to be developed was applied
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group/1st group ( standard physiotherapy
Intervention Description
It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
Intervention Type
Other
Intervention Name(s)
2nd group- Standard physiotherapy + bicycle ergometer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
3rd group- Standard physiotherapy + exercise protocol to be developed
Intervention Description
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. Portable indirect calorimetry will be used to measure the basal metabolic rates of the patients. The basal metabolic rates of the patients will be measured before the exercise and aerobic exercise or resistant exercise will be given according to the metabolic state of the patient. Ratings of perceived exertion (RPE) will be used as the aerobic exercise protocol and a 10-11 strength exercise will be given according to the RPE. If resistance exercise will be given, the intensity of the exercise (12-14) will be determined according to the RPE. Sandbags attached to the ankle will be used as a resistance exercise and 9 exercises were determined. (Knee extension, knee flexion, trunk flexion, trunk extension, hip extension, hip flexion, hip abduction, shoulder flexion, shoulder abduction
Primary Outcome Measure Information:
Title
D-dimer (To measure coagulation changes and Fibrinolytic Activity)
Description
blood test
Time Frame
Each participant will be evaluated for 6 weeks.
Title
fibrinogen (to measure changes in both coagulation and fibrinolytic activity)
Description
blood test
Time Frame
Each participant will be evaluated for 6 weeks.
Title
prothrombin time
Description
blood test
Time Frame
Each participant will be evaluated for 6 weeks.
Title
platelets (to measure changes in both coagulation and fibrinolytic activity)
Description
blood test
Time Frame
Each participant will be evaluated for 6 weeks.
Title
6 min walking test
Description
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
Time Frame
Each participant will be evaluated for 6 weeks.
Title
physiological consumption index
Description
Physiological consumption index (PCI) was calculated ((walking heart rate) - (resting heart rate)) / (walking speed)]. 1
Time Frame
Each participant will be evaluated for 6 weeks.
Title
MRC scale ( Manaul muscle test)
Description
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.
Time Frame
Each participant will be evaluated for 6 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat A ÇINAR
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30977897
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.
Results Reference
background
PubMed Identifier
19652939
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.
Results Reference
background
PubMed Identifier
19793561
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.
Results Reference
background
PubMed Identifier
20958968
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.
Results Reference
result
PubMed Identifier
31475319
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.
Results Reference
result
PubMed Identifier
26854881
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.
Results Reference
result
PubMed Identifier
31864784
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.
Results Reference
result

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Investigation of the Effect of Exercise Protocol Determined According to Metabolic Rate in Early Burn Patients on Coagulation, Fibrinolytic Activity and Functional Capacity

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