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The effect of rehabilitation program on intensive care unit acquired weakness

Protocol summary

Study aim
Determining the implementation of rehabilitation in the Intensive care unit weakness
Design
This study is a two-group clinical trial. a random allocation method with blocks of 4 of equal size and a combination of even numbers for the intervention group and odd numbers for the control group will be allocated into two control and intervention groups. For this purpose, a table of odd and even numbers has been prepared without a specific pattern and order. The sample size of each group is 30 people.
Settings and conduct
In the intensive care unit of Imam Khomeini hospital, physiotherapy will be performed for 14 days.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study include: patients aged 18 to 60 years, hospitalized in the intensive care unit, a written order from the doctor to perform rehabilitation, written consent from the patient or his/her guardian, level of consciousness score based on the Glasgow Coma Scale above 10, stable hemodynamic status, BMI under 35 kg/m2, absence of underlying neuromuscular diseases such as myasthenia gravis, absence of spine damage The exclusion criteria include: death of the patient, entering the acute stages of the disease, instability of hemodynamic conditions, being diagnosed with deep vein thrombosis , unwillingness to continue cooperation in the physical rehabilitation program on behalf of the patient or his family.
Intervention groups
In the control group, patients who meet the entry criteria complete the study tools after obtaining informed consent. In the intervention group, after obtaining informed consent, the study tools are completed, then the physical therapy of the organs is performed for 14 days, twice a day for 20 minutes. In case of transfer to the ward, the intervention will continue until the end of the 14th day.
Main outcome variables
Muscle weakness and strength, deep tendon reflex

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190913044760N2
Registration date: 2023-07-29, 1402/05/07
Registration timing: retrospective

Last update: 2023-07-29, 1402/05/07
Update count: 0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Zahra Abbbasi Dolatabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4401
Email address
zahra_abasi2000@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
2023-04-09, 1402/01/20
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2023-07-23, 1402/05/01
Scientific title
The effect of rehabilitation program on intensive care unit acquired weakness
Public title
The effect of rehabilitation program on intensive care unit acquired weakness
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to 60 years written consent from patient or her/his guardian admission to the intensive care unite Body mass index Below 35 kg/m2 written doctor`s order to perform rehabilitation level of consciousness based on glasgow coma test above 10 stable hemodynamic status Absence of background diseases such as myasthenia gravis no damage to the spine
Exclusion criteria:
death of the patient Entering the acute stages of the disease Hemodynamic instability diagnosed with Deep vein thrombosis Unwillingness to cooperate on behalf of the patient or her/his guardian
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: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to two control and intervention groups using the block random allocation method with blocks of 4 of equal size and a combination of even numbers for the intervention group and odd numbers for the control group. For this purpose, a table of odd and even numbers has been prepared without a specific pattern and order, and thus the allocation method is determined.
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 Imam Khomeini Hospital of Tehran University of Medical Sciences
Street address
58 / 5,000 Translation results Keshavarz Blvd., Doctor Gharib St., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.216

Health conditions studied

1

Description of health condition studied
intensive care unit acquired weakness
ICD-10 code
G72.81
ICD-10 code description
Critical illness myopathy

Primary outcomes

1

Description
Index of muscle weakness, muscle strength and deep tendon`s reflexe
Timepoint
Before and after intervention
Method of measurement
Using the Medical Research Council questionnaire for muscle weakness (MRC), which measures the flexion and extension movement of 6 muscle groups as points and is scored from 0 to 60, and a score below 48 is considered muscle weakness.

2

Description
The effect of rehabilitation program on muscle strength
Timepoint
Before and after intervention
Method of measurement
Using a tool called a handgrip dynamometer is used to measure hand strength based on kilograms.

Secondary outcomes

1

Description
The effect of rehabilitation program on deep tendon reflex
Timepoint
Before and after intervention
Method of measurement
Using a questionnaire called DTR, the tendon reflex of the biceps, triceps, brachioradialis, knee and ankle muscles is measured from 0 to +4.

Intervention groups

1

Description
Control group: In the intensive care unit of Imam Khomeini hospital, as a control, patients and their guardians are asked to complete the study tools after obtaining informed consent. The above process will continue until reaching the determined sample size.
Category
Rehabilitation

2

Description
Intervention group: In the Intensive care unit of Imam Khomeini Hospital, the instrument under study is completed after obtaining informed consent from the patients who meet the entry criteria or their guardians. Then the physical therapy of the organs is performed for 14 days, twice a day (10 AM- 4PM) for 20 minutes under the supervision of a physiotherapist. The study tool will be completed again at the end of the 14th day.In case of transfer to the ward, the intervention will continue until the end of the 14th day.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital complex
Full name of responsible person
Moahammad Amin Matufi Azar
Street address
Dr. gharib street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohamadali Sahraiean
Street address
Sixth floor, Vice Chancellor for Research and Technology, Central University Organization, corner of Quds Street, Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Matufi Azar
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Medical surgical nursing
Street address
Zafar street
City
Tehran
Province
Tehran
Postal code
1911735547
Phone
+98 21 2226 1540
Email
amin76tums@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Abasi Dolatabadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Disaster Health Management and Emergency Nursing
Street address
Mirkhani Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4329
Email
zahra_abasi2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Amin Matufi Azar
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
medical surgical nursing
Street address
Zafar street
City
Tehran
Province
Tehran
Postal code
1911735547
Phone
+98 21 2226 1540
Email
amin76tums@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All unidentifiable data can be provided if required
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers working in scientific institutes and universities who send requests
Under which criteria data/document could be used
The data can be used in accordance with copyright law and for further research in this field
From where data/document is obtainable
Send an email to Mr.Mohammad Amin Matufi Azar at amin76tums@gmail.com
What processes are involved for a request to access data/document
After reviewing the application and the applicant's conditions, if approved, the data will be sent within a month.
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