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The effect of eight weeks of combined aerobic-electrical stimulation and resistance-electrical stimulation exercises on the serum levels of IL-6, vWF, LDL, HDL and ADAMTS13 activity in men with ischemic stroke

Protocol summary

Study aim
Determining the effect of eight weeks of combined aerobic-electrical stimulation and resistance-electrical stimulation exercises on the serum levels of IL-6, vWF, LDL, HDL and ADAMTS13 activity in men with ischemic stroke.
Design
Due to the use of a human sample, this research is carried out in a semi-experimental way and in the form of a pre-test, post-test research design. The statistical population of this research is 40 men suffering from ischemic stroke from the clients of Tavana Physiotherapy Clinic in Hamedan, who were randomly divided into four groups of 10 people, including the combined exercise group (aerobic-electrical stimulation), the combined exercise group (resistance-electrical stimulation), the group of electrical stimulation alone and the control group are divided.
Settings and conduct
Before the start of training and 48 hours after the last training session, blood sampling will be done from all the subjects fasting by a laboratory expert. Then, after clotting and centrifugation, the serum sample will be separated and then in Hakim Hamedan laboratory at -80 degrees. Centigrade is kept until the levels of serum IL-6, vWF, LDL, HDL and ADAMTS13 activity are measured with an ELISA kit.
Participants/Inclusion and exclusion criteria
Entry requirements: Men with first or second ischemic stroke Age range 55-85 years Not taking any food supplements The patient has at least grade 3 muscle strength Able to walk at least 10 meters unaided or with assistive devices Non-entry conditions: Cardiovascular patients, hemorrhagic stroke
Intervention groups
Three intervention groups (aerobic-electrical stimulation, resistance-electrical stimulation and electrical stimulation only) and a control group that has no intervention until the end of the research.
Main outcome variables
The serum levels of IL-6, vWF, LDL, HDL and ADAMTS13 activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240922063118N1
Registration date: 2024-11-21, 1403/09/01
Registration timing: retrospective

Last update: 2024-11-21, 1403/09/01
Update count: 0
Registration date
2024-11-21, 1403/09/01
Registrant information
Name
Morteza Mostaghimi
Name of organization / entity
Boali University of Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 81 3442 8158
Email address
saeiandbibak@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of combined aerobic-electrical stimulation and resistance-electrical stimulation exercises on the serum levels of IL-6, vWF, LDL, HDL and ADAMTS13 activity in men with ischemic stroke
Public title
The effect of exercise with electrical stimulation on inflammation and hemostasis system in stroke patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men with first or second ischemic stroke with right or left hemiparesis Age 55-85 years Not taking any food supplements for 3 months before the research The patient has at least grade 3 muscle strength from manual muscle test Able to walk at least 10 meters without assistance or with assistive devices
Exclusion criteria:
Cardiovascular discomfort The patient's inability to perform physical activity Hemorrhagic stroke
Age
From 55 years old to 85 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling framework was prepared by preparing a list including all subjects, which were numbered from 1 to 40. Then random numbers from 1 to 40 were selected using the Random Number Generator. Each number was placed in aerobic, resistance, electrical stimulation and control groups, which were finally divided into four groups of 10 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
All the subjects were informed about the objectives of the research from the beginning, but they were not given information about the research and intervention groups. They only did the exercises of each session under the supervision of the researcher.objectives.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Boali Sina University, Hamedan
Street address
No. 12, Fedayian Islam Alley, Azadegan Blvd.
City
Hamedan
Province
Hamadan
Postal code
6518834386
Approval date
2024-08-28, 1403/06/07
Ethics committee reference number
IR.BASU.REC.1403.014

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
von Willebrand factor
Timepoint
Before the start of the exercise and after the end of the exercise
Method of measurement
ELISA kit

2

Description
ADAMTS13
Timepoint
Before the start of the exercise and after the end of the exercise
Method of measurement
ELISA kit

3

Description
Interleukin 6
Timepoint
Before the start of the exercise and after the end of the exercise
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aerobic-Electrical stimulation
Category
Diagnosis

2

Description
Intervention group: Resistance-Electrical stimulation
Category
Diagnosis

3

Description
Intervention group: Electrical stimulation
Category
Diagnosis

4

Description
Control group: Control
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Clinic, Hamadan
Full name of responsible person
Dr. Mehrdakht Mazdeh
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Street, Shariati Square
City
Hamedan
Province
Hamadan
Postal code
6518834385
Phone
+98 81 3442 5668
Email
saeiandbibak@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Assistant of Bu-Ali Sina University
Full name of responsible person
Dr. Arash Ghorbani Chaghamarani
Street address
Research and Technology Office of an assistant, Bu-Ali Sina University, Martyr Mostafa Ahmadi Roshan Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۹۵
Phone
+98 81 3140 5555
Email
a.ghorbani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Bu-Ali Sina University
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
Boali Sina University
Full name of responsible person
Morteza Mostaghimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 12, Fedayian Islam Alley, Azadegan Blvd.
City
Hamedan
Province
Hamadan
Postal code
6518834386
Phone
+98 81 3442 8158
Email
saeiandbibak@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Morteza Mostaghimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 12, Fedayian Islam Alley, Azadegan Blvd.
City
Hamedan
Province
Hamadan
Postal code
6518834386
Phone
+98 81 3442 8158
Email
Saeiandbibak@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Morteza Mostaghimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 12, Fedayian Islam Alley, Azadegan Blvd.
City
Hamedan
Province
Hamadan
Postal code
6518834386
Phone
+98 81 3442 8158
Email
Saeiandbibak@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
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
No - There is not a plan to make this available
Title and more details about the data/document
Only non-confidential documents and items will be shared
When the data will become available and for how long
1 year after the results are published
To whom data/document is available
Academic researchers and neurologists
Under which criteria data/document could be used
Only for the scientific and therapeutic use of researchers and specialists in the field of treatment
From where data/document is obtainable
Faculty of Physical Education and Sports Sciences, Boali Sina University, Hamedan
What processes are involved for a request to access data/document
Email to the author responsible for the published article
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