Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663113
Recruitment Status : Completed
First Posted : December 10, 2020
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Murat Ali ÇINAR, 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.


Condition or disease Intervention/treatment Phase
Burns Other: Control Group/1st group ( standard physiotherapy Other: 2nd group- Standard physiotherapy + bicycle ergometer Other: 3rd group- Standard physiotherapy + exercise protocol to be developed Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)

Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2020
Actual Primary Completion Date : May 1, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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





Primary Outcome Measures :
  1. D-dimer (To measure coagulation changes and Fibrinolytic Activity) [ Time Frame: Each participant will be evaluated for 6 weeks. ]
    blood test

  2. fibrinogen (to measure changes in both coagulation and fibrinolytic activity) [ Time Frame: Each participant will be evaluated for 6 weeks. ]
    blood test

  3. prothrombin time [ Time Frame: Each participant will be evaluated for 6 weeks. ]
    blood test

  4. platelets (to measure changes in both coagulation and fibrinolytic activity) [ Time Frame: Each participant will be evaluated for 6 weeks. ]
    blood test

  5. 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

  6. 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

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663113


Locations
Layout table for location information
Turkey
Hasan Kalyoncu University
Gaziantep, Turkey, 27000
Sponsors and Collaborators
Hasan Kalyoncu University
Investigators
Layout table for investigator information
Principal Investigator: Murat A ÇINAR Hasan Kalyoncu University
Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Murat Ali ÇINAR, Resarch Asistant, Physical Therapist, Hasan Kalyoncu University
ClinicalTrials.gov Identifier: NCT04663113    
Other Study ID Numbers: MAC2020
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Murat Ali ÇINAR, Hasan Kalyoncu University:
physiotherapy
Burn rehabilitation
Major burns
Additional relevant MeSH terms:
Layout table for MeSH terms
Burns
Wounds and Injuries