BurnsNCT03520816
The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
A study testing Burn Physiotherapy Protocol in people with Burns and Physiotherapy, run by Hasan Kalyoncu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 47 years
- Conditions the study is for
- Burns, Physiotherapy, Exercises
- What is being tested?
- Burn Physiotherapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 47 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18 years
- Major burn injury (according to ABA)
- Conscious patients
Who cannot join
- Inhalation injury
- Various chronic disorders
- Organ dysfunctions
About this study
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.
- Conditions
- Burns, Physiotherapy, Exercises
- Being tested
- Burn Physiotherapy Protocol
- Keywords
- Fibronectin, Prealbumin, Physiotherapy, Major Burns, biochemical parameters
- Medical subject headings
- Burns, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Burn Physiotherapy Protocol |
| Control Group | No intervention | The control group consisted of patients who could not receive physiotherapy due to various reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibronectin
Blood test
Measured: Changes in fibronectin at 6 weeks later
Prealbumin
Blood test
Measured: Changes in prealbumin at 6 weeks later
C-reactive protein
Blood test
Measured: Changes in C-reactive protein at 6 weeks later
Transferrin
Blood test
Measured: Changes in transferrin at 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Oct 2016
- Primary completion1 Feb 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ali ÇINAR,MSc,PT, Hasan Kalyoncu University
- Investigators
- MURAT ALİ ÇINAR, Msc, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520816
- Sponsor's protocol ID
- 2016-12
- Status last verified
- May 2018
- First submitted
- 17 Apr 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 27574647Mandell 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.
PubMed 24761346Gillenwater 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.
PubMed 28576238Chinese 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.
PubMed 27574666Luzzani 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.
PubMed 12794413
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Physiotherapy on Biochemical Parameters in Major Burn Patients: A Burn Center's Experience
- ClinicalTrials.gov ID
- NCT03520816
- Acronym / sponsor ID
- 2016-12
- Conditions
- Burns, Physiotherapy, Exercises
- Keywords
- Fibronectin, Prealbumin, Physiotherapy, Major Burns, biochemical parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn Physiotherapy Protocol Group | Experimental | Other: Burn Physiotherapy ProtocolPatients in the treatment group have been received to the physiotherapy programme from the first day of their stay in the hospital. |
| Control Group | No intervention | –The control group consisted of patients who could not receive physiotherapy due to various reasons. |
Who may qualify
- Ages
- 21 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Major burn injury (according to ABA)
- Conscious patients
Key exclusion criteria (3 listed)
- Inhalation injury
- Various chronic disorders
- Organ dysfunctions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Burn Physiotherapy ProtocolIt consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises. | Other | Burn Physiotherapy Protocol Group |
Primary outcome
Fibronectin
Time frame: Changes in fibronectin at 6 weeks later
Blood test
Prealbumin
Time frame: Changes in prealbumin at 6 weeks later
Blood test
C-reactive protein
Time frame: Changes in C-reactive protein at 6 weeks later
Blood test
Transferrin
Time frame: Changes in transferrin at 6 weeks later
Blood test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Results publication: PubMed 27574647Lee 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 publication: PubMed 24761346Mandell 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 publication: PubMed 28576238Gillenwater 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 publication: PubMed 27574666Chinese 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 publication: PubMed 12794413Luzzani 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MURAT ALİ ÇINAR, Msc principal investigator
Hasan Kalyoncu University
Questions about this trial
What is this clinical trial studying?
A study testing Burn Physiotherapy Protocol in people with Burns and Physiotherapy, run by Hasan Kalyoncu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibronectin (time frame: Changes in fibronectin at 6 weeks later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.