Effect of inspiratory muscle training(IMT) on the strength of respiratory muscles and the quality of life in patients with burn
Design
Clinical Trial including CG with parallel groups without blindness
is randomized by sequencing the software promiscuously.
Settings and conduct
This study was conducted in the Burn Ward of Imam Reza Hospital in Mashhad . The main tools used are SF36 quality of life measurement questionnaire and PBD for measuring the inspiratory muscle strenght and training .The strenght of the inspiratory muscles is measured by the PBD in both groups. Then in both groups routine training including CP and IS are performed for 20 minutes once a day for three weeks or more and intervention group IMT which included 30 breath twice a day for three weeks or more by PBD. It will be added to routine training in the IG , the measurement of respiratory muscle strenght and completing the SF36 questionnaire will be done in both groups before and after of intervention.
Participants/Inclusion and exclusion criteria
The Inclusion Criteria : Alert , adult aged 18-60 years , TBSA:20-50% ,Burns of the back and front chest area , stable hemodynamic status , lack of burn in the lips and mouth , inhalation burns not dependent on ventilator and oxygen , Pimax less than 60 cmh2o ; The Exclusion Criteria :Sever cardiovascular and pulmonary disorders requiring medical treatment , patients who die or discharge earlier than 3 weeks.
Intervention groups
In the intervention group(IG) , in addition to chest physiotherapy
(CP) and incentive spirometry(IS) , the IMT by Powerbreath Device(PBD) includ 30 breaths twice a day for three weeks or more , under supervision to researchers will be done. In the Control Group(CG) , CP and IS will be performed for 20 minutes once a day for three weeks and more by the physiotherapist.
Main outcome variables
respiratory muscles strenght and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181225042110N1
Registration date:2019-03-16, 1397/12/25
Registration timing:registered_while_recruiting
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
elahe abazarnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 1083
Email address
abazarnezhade951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-05, 1397/12/14
Expected recruitment end date
2019-06-04, 1398/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of inspiratory muscle training on the strength of respiratory muscles and the quality of life in patients with burn
Public title
Effect of inspiratory muscle training on the strength of respiratory muscles and the quality of life in patients with burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
alert
Age: 18-60 years
TBSA:20-50%
Stable hemodynamic status
Lack of burn in the lips and mouth
Absence of ventilator and oxygen inhalation burns
Pimax is less than 60 cmh2o
Burns of the back and front chest area
Exclusion criteria:
Severe cardiovascular and pulmonary disorders requiring medical treatment.
Patients who die or discharge earlier than 3 weeks.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random assignment using random sequence generated by SPSS software without concealment with parallel groups is used to select patients in both intervention and control groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of medical sciences
Street address
Ghorayshi Building, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.086
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20_T25
ICD-10 code description
Burns and corrosions of external body surface , specified by site
Primary outcomes
1
Description
Respiratory muscle strength
Timepoint
Measurement of respiratory muscle strength before the start and end of the intervention
Method of measurement
The measurement of inspiratory muscle strength by Power Breath Device
2
Description
Quality of life
Timepoint
Measurement of quality of life before the start and end of the intervention
Method of measurement
SF36 questionnaire of quality of life
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Inspiratory muscle training will be added by Powerbreath Device include 30 breath twice a day for 3 weeks and more to incentive spirometry and chest physiotherapy In the intervention group . At first inspiratory muscle strenght will be measured in both groups (control /intervention) by Power Breath Device. The sign of inspiratory muscle weakness is inspiratory muscle strenght under 60 cmh2o. training in the intervention group is 30% of Pimax that is leveled primarily .This function will be done to investigate respiratory muscle strength and the quality of life of the patients in both groups(control/intervention) at the start and at the end of the intervention.
Category
Rehabilitation
2
Description
Control Group: The routine training including incentive spirometry and chest physiotherapy for 20 minutes once a day for 3 weeks and more will be done In the control group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital Burn Center
Full name of responsible person
Ali Ahmadabadi
Street address
Imam Reza Hospital, The Skirts of Imam Reza Square , Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
The University for Research and Technology Assistance, Mashhad University of Medical Sciences , Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
971322
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raziye Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
آدرس خیابان School of Nursing and Midwifery , Ibn Sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raziye Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery , Ibn Sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elahe Abazarnezhad
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery , Ibn Sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
abazarnezhade951@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD