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

April 10, 2022 updated by: Murat Ali ÇINAR, Hasan Kalyoncu University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27000
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
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
It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
Experimental: Aerobic Exercises group
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

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.
Experimental: the group in which the exercise protocol to be developed was applied
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D-dimer (To measure coagulation changes and Fibrinolytic Activity)
Time Frame: Each participant will be evaluated for 6 weeks.
blood test
Each participant will be evaluated for 6 weeks.
fibrinogen (to measure changes in both coagulation and fibrinolytic activity)
Time Frame: Each participant will be evaluated for 6 weeks.
blood test
Each participant will be evaluated for 6 weeks.
prothrombin time
Time Frame: Each participant will be evaluated for 6 weeks.
blood test
Each participant will be evaluated for 6 weeks.
platelets (to measure changes in both coagulation and fibrinolytic activity)
Time Frame: Each participant will be evaluated for 6 weeks.
blood test
Each participant will be evaluated for 6 weeks.
6 min walking test
Time Frame: 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
Each participant will be evaluated for 6 weeks.
physiological consumption index
Time Frame: Each participant will be evaluated for 6 weeks.
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)
Time Frame: 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.
Each participant will be evaluated for 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Principal Investigator: Murat A ÇINAR, Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAC2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burns

Clinical Trials on Control Group/1st group ( standard physiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe