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
About this trial
This is an interventional treatment trial for Burns focused on measuring Fibronectin, Prealbumin, Physiotherapy, Major Burns, biochemical parameters
Eligibility Criteria
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
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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