- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03520816
The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years
- Major burn injury (according to ABA)
- Conscious patients
Exclusion Criteria:
- Inhalation injury
- Various chronic disorders
- Organ dysfunctions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Burn Physiotherapy Protocol Group
Patients in the treatment group have been received to the physiotherapy programme from the first day of their stay in the hospital.
|
It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises.
|
|
NO_INTERVENTION: Control Group
The control group consisted of patients who could not receive physiotherapy due to various reasons.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fibronectin
Time Frame: Changes in fibronectin at 6 weeks later
|
Blood test
|
Changes in fibronectin at 6 weeks later
|
|
Prealbumin
Time Frame: Changes in prealbumin at 6 weeks later
|
Blood test
|
Changes in prealbumin at 6 weeks later
|
|
C-reactive protein
Time Frame: Changes in C-reactive protein at 6 weeks later
|
Blood test
|
Changes in C-reactive protein at 6 weeks later
|
|
Transferrin
Time Frame: Changes in transferrin at 6 weeks later
|
Blood test
|
Changes in transferrin at 6 weeks later
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MURAT ALİ ÇINAR, Msc, Hasan Kalyoncu University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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