Protocol summary

Study aim
Determining the effect of passive walking-like exercises on cardiac and respiratory parameters of patients admitted to intensive care units
Design
Clinical trial with control group, with parallel groups, without blinding, open-lable, random with 50 patients. Used to randomize the blocking method with Allocation Random software.
Settings and conduct
The study in the intensive care unit, on patients' beds, the passive walking method is repeated 5 times a week for 2 weeks, each time for 20 minutes is performed. Due to the unavailability of the device, the simulated protocol is performed. Step 1and 2: Flexion-extension of the right and then left thigh with a maximum range of 45 degrees at a speed of 30 times per minute for 10 minutes; Steps 3 and 4: Flexion-extension of the right knee and then left with a maximum range of motion of 60 degrees and dorsi-plantar flexion of the right ankle and then left with a maximum range of motion of 10 and 15 degrees simultaneously at speed of 30 times per minute, for 10 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least 18, connected to a mechanical ventilation hemodynamic and cardiac stability, confirmation of the treating physician, written consent؛ Exclusion criteria: increased intracranial pressure, having a neuromuscular disease, spinal cord injury, cardiopulmonary arrest, fractures in the lower limbs
Intervention groups
For the control group, routine care and for the intervention group, in addition to routine care, passive walking exercises are performed
Main outcome variables
Shock index؛ MAP؛ Airway resistance؛ Compliance؛ PaO2 / FiO2؛ Peak pressure؛ SBP and DBP؛ HR؛ respiration rate؛ Saturation of Peripheral Oxygen

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211119053107N1
Registration date: 2022-01-09, 1400/10/19
Registration timing: registered_while_recruiting

Last update: 2022-01-09, 1400/10/19
Update count: 0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Yosra Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3336 0979
Email address
yosrakarimi@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-03-22, 1401/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of passive walking -like Exercise on cardiac and respiratory parameters of patients admitted to intensive care units: Controlled Clinical Trial
Public title
Study of the effect of passive walking exercises on the cardiac and respiratory system of patients admitted to intensive care units
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old Connecting to a mechanical ventilation that is at least 24 hours old Hemodynamic and cardiac stability Confirmation of the treating physician that the patient is not prohibited from performing the protocol Obtaining written consent from the patient's legal guardian
Exclusion criteria:
Increasing of intracranial pressure Having a history of previous or rapidly growing neuromuscular disease Spinal cord injury Cardiopulmonary arrest Having fractures in the pelvis and lower limbs
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The first step of creating a random sequence: In this study, the limited randomization method of block randomization will be used. In this two-group experiment, we will have four blocks consisting of two participants in the intervention group and two participants in the control group. There will be six different modes in these four blocks; So we prepare six cards as follows: 3. PMPM 2. PMMP 1. PPMM 4. MPMP 6. MPPM 5. MMPP Given that the number of patients studied is estimated at 50, we remove 13 of the above cards by replacement. The second step of hiding accident allocation: The selection of cards will be determined using a table of random numbers in Software Allocation Random. Blocking and allocation sequencing for concealment will be done by the person not involved in the research. Then, based on the obtained blocks and allocation sequence, they will be divided into 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 Kermanshah University of Medical Sciences
Street address
Deputy of Research and Technology; Building No. 2 of Medical Sciences; Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2021-12-14, 1400/09/23
Ethics committee reference number
IR.KUMS.REC.1400.605

Health conditions studied

1

Description of health condition studied
Respiratory failure
ICD-10 code
J96.9
ICD-10 code description
Respiratory failure, unspecified

2

Description of health condition studied
Heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified

Primary outcomes

1

Description
Average shock index
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Shock Index=(Heart Rate)/(Systolic Blood Pressure)- Physiological indicators(Cardiorespiratory monitoring)

2

Description
Average of mean arterial pressure
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Mean arterial pressure = (systole + 2 diastole) / 3 _ Physiological indicators(pressure indicator)

3

Description
Average airway resistance
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Airway resistance= tail end wedge pressure - alveolar_ ventilator pressure_ ventilator

4

Description
Average compliance
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Compliance = volume change / pressure change_ ventilator

5

Description
Average relative arterial oxygen pressure to percentage of tail oxygen
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
PaO2 / FiO2=Relative arterial oxygen pressure / percentage of tail oxygen - a tool for measuring _Physiological indicators(Cardiorespiratory monitoring)

6

Description
Average peak inspiratory pressure
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
ventilator

7

Description
Average systolic and diastolic blood pressure
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Physiological indicators(pressure indicator)

8

Description
Average heart rate
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Physiological indicators(Cardiorespiratory monitoring)

9

Description
Average respiration rate
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Physiological indicators(Cardiorespiratory monitoring)

10

Description
Average percentage of peripheral blood oxygen saturation
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Physiological indicators(Cardiorespiratory monitoring)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the intervention group, in addition to routine care, it will perform passive walking exercises. The passive walking method is repeated 5 times a week for 2 weeks and 20 minutes of practice each time. Walking involves moving the hip, knee and ankle joints. Due to the unavailability of the device and the high cost of providing the device, the simulated walking of the protocol is performed as follows: Step 1: Flexion-extension of the right thigh with a maximum range of 45 degrees at a speed of 30 times per minute , Runs for 10 minutes; Second stage: Flexion-extension of the left thigh is practiced similarly to the right thigh; Runs 30 times per minute for 10 minutes; Step 4: According to the third step, flexion-knee extension and dorsi-plantar flexion of the left ankle are practiced; The researcher goes to the intensive care unit and on the patient's bed, performs this procedure for 2 weeks (5 sessions per week) while the patient is lying down and about 30 degrees above the head.
Category
Treatment - Other

2

Description
Control group: do not receive intervention, receive routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Dr Alireza Abdi
Street address
Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3837 0252
Email
heartcenter@kums.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital
Full name of responsible person
Dr Alireza Abdi
Street address
Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 7984
Email
crdu.taleghani@gmail.com

3

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr Alireza Abdi
Street address
Naghlieh Street
City
Kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
+98 83 3727 2049
Email
imf.kums@gmail.com

4

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr Alireza Abdi
Street address
End of Nurse Boulevard - next to the medical school
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6301
Email
irhk@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Deputy of Research and Technology; Building No. 2 of Medical Sciences; Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Fax
+98 83 3837 0541
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Yosra Karimi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Dolatabad; Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3816 2532
Fax
+98 83 3816 2181
Email
yosrakarimi@ymail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Dolatabad; Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3816 2532
Fax
+98 83 3816 2181
Email
A_abdi61@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yosra Karimi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Dolatabad; Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3816 2532
Fax
+98 83 3816 2181
Email
yosrakarimi@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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