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

NCT04663113 | Completed

• 1 other identifier: MAC2020
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

physiotherapy; Burn rehabilitation; Major burns

Outcome Measures

Primary Outcomes (7)

• D-dimer (To measure coagulation changes and Fibrinolytic Activity)

  blood test

  Each participant will be evaluated for 6 weeks.

• fibrinogen (to measure changes in both coagulation and fibrinolytic activity)

  blood test

  Each participant will be evaluated for 6 weeks.

• prothrombin time

  blood test

  Each participant will be evaluated for 6 weeks.

• platelets (to measure changes in both coagulation and fibrinolytic activity)

  blood test

  Each participant will be evaluated for 6 weeks.

• 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

  Each participant will be evaluated for 6 weeks.

• physiological consumption index

  Physiological consumption index (PCI) was calculated ((walking heart rate) - (resting heart rate)) / (walking speed)\]. 1

  Each participant will be evaluated for 6 weeks.

• 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.

  Each participant will be evaluated for 6 weeks.

Study Arms (3)

Control group

OTHER

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/1st group ( standard physiotherapy

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: 2nd group- Standard physiotherapy + bicycle ergometer

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

EXPERIMENTAL

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.

Other: 3rd group- Standard physiotherapy + exercise protocol to be developed

Interventions

Control Group/1st group ( standard physiotherapy OTHER

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

Control group

2nd group- Standard physiotherapy + bicycle ergometer OTHER

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.

Aerobic Exercises group

3rd group- Standard physiotherapy + exercise protocol to be developed OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 30977897 BACKGROUND

• 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.

  PMID: 19652939 BACKGROUND

• 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.

  PMID: 19793561 BACKGROUND

• 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.

  PMID: 20958968 RESULT

• 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.

  PMID: 31475319 RESULT

• 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.

  PMID: 26854881 RESULT

• 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.

  PMID: 31864784 RESULT

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Murat A ÇINAR

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

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: Resarch Asistant, Physical Therapist

Model Details: 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)

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 10, 2020
• Study Start: November 15, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)