NCT03520816

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

April 17, 2018

Last Update Submit

May 9, 2018

Conditions

BurnsPhysiotherapyExercises

Keywords

FibronectinPrealbuminPhysiotherapyMajor Burnsbiochemical parameters

Outcome Measures

Primary Outcomes (4)

  • Fibronectin

    Blood test

    Changes in fibronectin at 6 weeks later

  • Prealbumin

    Blood test

    Changes in prealbumin at 6 weeks later

  • C-reactive protein

    Blood test

    Changes in C-reactive protein at 6 weeks later

  • Transferrin

    Blood test

    Changes in transferrin at 6 weeks later

Study Arms (2)

Burn Physiotherapy Protocol Group

EXPERIMENTAL

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

Other: Burn Physiotherapy Protocol

Control Group

NO INTERVENTION

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

Interventions

Burn Physiotherapy ProtocolOTHER

It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises.

Burn Physiotherapy Protocol Group

Eligibility Criteria

Age21 Years - 47 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Inhalation injury
  • Various chronic disorders
  • Organ dysfunctions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 27574647RESULT

  • 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.

    PMID: 24761346RESULT

  • 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.

    PMID: 28576238RESULT

  • 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.

    PMID: 27574666RESULT

  • 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.

    PMID: 12794413RESULT

MeSH Terms

Conditions

BurnsMotor Activity

Condition Hierarchy (Ancestors)

Wounds and InjuriesBehavior

Study Officials

  • MURAT ALİ ÇINAR, Msc

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resarch Asistant

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 11, 2018

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share
Shared Documents
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