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The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience

Primary Purpose

Burns, Physiotherapy, Exercises

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Burn Physiotherapy Protocol
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 Fibronectin, Prealbumin, Physiotherapy, Major Burns, biochemical parameters

Eligibility Criteria

21 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Major burn injury (according to ABA)
  • Conscious patients

Exclusion Criteria:

  • Inhalation injury
  • Various chronic disorders
  • Organ dysfunctions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Burn Physiotherapy Protocol Group

    Control Group

    Arm Description

    Patients in the treatment group have been received to the physiotherapy programme from the first day of their stay in the hospital.

    The control group consisted of patients who could not receive physiotherapy due to various reasons.

    Outcomes

    Primary Outcome Measures

    Fibronectin
    Blood test
    Prealbumin
    Blood test
    C-reactive protein
    Blood test
    Transferrin
    Blood test

    Secondary Outcome Measures

    Full Information

    First Posted
    April 17, 2018
    Last Updated
    May 9, 2018
    Sponsor
    Hasan Kalyoncu University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03520816
    Brief Title
    The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
    Official Title
    The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    February 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (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
    Background: This study planned to investigate the effect of early physiotherapy on biochemical parameters in major burn patients. Methods: Ten women (50%) and 10 men (50%) aged 21-47 years old were included in our study. Participants were divided into two groups: one group was the treatment group and the other was the control group. In the treatment group, patients were admitted to the physiotherapy programme from the first day they have been hospitalised, in addition to their routine treatment (medical, surgery, etc.), for 4 days per week. It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises. The days of treatment were determined as Tuesday, Wednesday, Thursday and Friday. Patients could not be treated on a Monday because that was surgery day. The control group consisted of patients who could not receive physiotherapy due to various reasons. All patients included in the study were evaluated weekly for 6 weeks after admission to the hospital. Parameters such as demographic information, characteristics of burn injury, C-reactive protein, fibronectin, transferrin and prealbumin were evaluated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burns, Physiotherapy, Exercises
    Keywords
    Fibronectin, Prealbumin, Physiotherapy, Major Burns, biochemical parameters

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Burn Physiotherapy Protocol Group
    Arm Type
    Experimental
    Arm Description
    Patients in the treatment group have been received to the physiotherapy programme from the first day of their stay in the hospital.
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The control group consisted of patients who could not receive physiotherapy due to various reasons.
    Intervention Type
    Other
    Intervention Name(s)
    Burn Physiotherapy Protocol
    Intervention Description
    It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises.
    Primary Outcome Measure Information:
    Title
    Fibronectin
    Description
    Blood test
    Time Frame
    Changes in fibronectin at 6 weeks later
    Title
    Prealbumin
    Description
    Blood test
    Time Frame
    Changes in prealbumin at 6 weeks later
    Title
    C-reactive protein
    Description
    Blood test
    Time Frame
    Changes in C-reactive protein at 6 weeks later
    Title
    Transferrin
    Description
    Blood test
    Time Frame
    Changes in transferrin at 6 weeks later

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    47 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years Major burn injury (according to ABA) Conscious patients Exclusion Criteria: Inhalation injury Various chronic disorders Organ dysfunctions
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MURAT ALİ ÇINAR, Msc
    Organizational Affiliation
    Hasan Kalyoncu University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    27574647
    Citation
    Lee KC, Joory K, Moiemen NS. History of burns: The past, present and the future. Burns Trauma. 2014 Oct 25;2(4):169-80. doi: 10.4103/2321-3868.143620. eCollection 2014.
    Results Reference
    result
    PubMed Identifier
    24761346
    Citation
    Mandell SP, Gibran NS. Early Enteral Nutrition for Burn Injury. Adv Wound Care (New Rochelle). 2014 Jan 1;3(1):64-70. doi: 10.1089/wound.2012.0382.
    Results Reference
    result
    PubMed Identifier
    28576238
    Citation
    Gillenwater J, Garner W. Acute Fluid Management of Large Burns: Pathophysiology, Monitoring, and Resuscitation. Clin Plast Surg. 2017 Jul;44(3):495-503. doi: 10.1016/j.cps.2017.02.008. Epub 2017 Apr 14.
    Results Reference
    result
    PubMed Identifier
    27574666
    Citation
    Chinese Burn Association; Chinese Association of Burn Surgeons; Cen Y, Chai J, Chen H, Chen J, Guo G, Han C, Hu D, Huan J, Huang X, Jia C, Li-Tsang CW, Li J, Li Z, Liu Q, Liu Y, Luo G, Lv G, Niu X, Peng D, Peng Y, Qi H, Qi S, Sheng Z, Tang D, Wang Y, Wu J, Xia Z, Xie W, Yang H, Yi X, Yu L, Zhang G; Chinese Burn Care and Rehabilitation Association. Guidelines for burn rehabilitation in China. Burns Trauma. 2015 Oct 21;3:20. doi: 10.1186/s41038-015-0019-3. eCollection 2015.
    Results Reference
    result
    PubMed Identifier
    12794413
    Citation
    Luzzani A, Polati E, Dorizzi R, Rungatscher A, Pavan R, Merlini A. Comparison of procalcitonin and C-reactive protein as markers of sepsis. Crit Care Med. 2003 Jun;31(6):1737-41. doi: 10.1097/01.CCM.0000063440.19188.ED.
    Results Reference
    result

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    The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience

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