Comparison of the effect of inspiratory muscle training with common chest physiotherapy on the weaning duration in patients hospitalized in intensive care units
The effect of adding muscle strengthening exercises by Threshold IMT to the physiotherapy and regular exercises on the strength of respiratory muscles and weaning time
Design
Clinical trial with control group, with parallel groups, one-way blinding, random assignment using closed-envelope method.
Settings and conduct
The present clinical trial will be performed on eligible patients admitted to the intensive care units of Imam Reza Hospital in Mashhad. In the intervention group, in addition to routine chest physiotherapy, daily muscle training exercises are performed in 5 series of 6 breaths with an intensity of 50% of maximal inspiratory pressure (MIP) for one week. In the control group, only routine chest physiotherapy will be performed. Participants (patients) are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Be hospitalized in the intensive care unit. Be connected to a ventilator for at least 24 hours. Be stable in hemodynamic status (Blood Pressure. Pulse Rate. Respiratory Rate, O2). Positive end-expiratory pressure (Peep) <10 cmH2O. Fractional Inspired Oxygen (FIO2) < 0.60%. Respiratory rate <25.
Exclusion criteria: It is not possible to continue muscle training exercises, for any reason. The patient's hemodynamic status becomes unstable.
Intervention groups
In the intervention group, in addition to routine chest physiotherapy, daily muscle training exercises are performed in 5 series of 6 breaths with an intensity of 50% of maximal inspiratory pressure (MIP) for one week. In the control group, only routine chest physiotherapy will be performed.
Main outcome variables
Strength of inspiratory muscles. Duration of ventilator weaning.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200915048728N1
Registration date:2021-02-28, 1399/12/10
Registration timing:registered_while_recruiting
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Farnoosh Khodabandeloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4241
Email address
f.khodabandeloo@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of inspiratory muscle training with common chest physiotherapy on the weaning duration in patients hospitalized in intensive care units
Public title
Comparison of the effect of inspiratory muscle training with common chest physiotherapy on the weaning duration in patients hospitalized in intensive care units
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be hospitalized in the intensive care unit.
Be connected to a ventilator for at least 24 hours
Be stable in hemodynamic status (Blood Pressure. Pulse Rate .Respiratory Rate, O2)
Positive end-expiratory pressure (Peep) <10 cmH2O
Fractional Inspired Oxygen (FIO2) < 0.60%
Respiratory rate <25/per minute
Exclusion criteria:
It is not possible to continue muscle training exercises, for any reason.
The patient's hemodynamic status becomes unstable
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The closed-envelope method is used. Random sequences generated are stored in these closed envelopes. After selecting the new eligible patient, the envelope is opened to determine his group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants (patients) are blinded.
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
Ghoreyshi building, Daneshgah street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.350
Health conditions studied
1
Description of health condition studied
patients under mechanical ventilation
ICD-10 code
Z99.11
ICD-10 code description
Dependence on respirator [ventilator] status
Primary outcomes
1
Description
Strength and endurance of respiratory muscle
Timepoint
Respiratory muscle strength before and after Inspiratory muscle training
Method of measurement
Measurement of inspiratory muscle strength by mechanical ventilator
2
Description
Duration of patient weaning from ventilator
Timepoint
At the beginning of the study, one week after starting the exercises and then every day
Method of measurement
Time to wean from the ventilator based on hour
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine chest physiotherapy, daily inspiratory muscle training will be performed in 5 series of 6 breaths with an intensity of 50% of maximal inspiratory pressure for one week.
Category
Rehabilitation
2
Description
Control group: They will only receive routine chest physiotherapy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Farnoosh Khodabandeloo
Street address
School of medicine, Bahonar Ave, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3881 4241
Email
f.khodabandeloo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah Street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
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
Ahmad Bagheri Moghaddam
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
School of medicine, Bahonar Ave, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3881 4241
Email
bagheria@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnoosh Khodabandeloo
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of medicine, Bahonar Ave, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3881 4241
Email
f.khodabandeloo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnoosh Khodabandeloo
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of medicine, Bahonar Ave, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3881 4241
Email
f.khodabandeloo@yahoo.com
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