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The effects of resistance exercise and training with blood flow restriction on platelet-activating factors in patients with type 2 diabetes

Protocol summary

Study aim
The aim of this study was to investigate the effect of resistance exercise with restricted blood flow on platelet indices and platelet-activating factors in patients with type 2 diabetes.
Design
The statistical population includes patients with type 2 diabetes in the age range of 30 to 60 years in Kashan. The sample size is 15 people who perform an exercise with blood flow restriction in one stage and exercise without the restriction of blood flow in the next stage.
Settings and conduct
Resistance activity includes two sessions of resistance activity with and without restriction of blood flow. The subjects perform two training protocols in two sessions with an interval of 4 to 6 days. In the first session, after 20-30 minutes of rest, the subjects perform the resistance activity protocol of 3 sets of 6 repetitions of knee opening with 80% of a maximum repetition and the rest time between sets is 2 minutes without restriction of blood flow. Then, in the second session, after 20-30 minutes of rest, they perform the protocol of resistance activity with an intensity of 20% 1RM in three sets with 15 repetitions with 30 seconds of rest between each set with limited blood flow. The place for exercising is the university gym. Blood samples are taken before, immediately and 30 minutes after activity.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes should not have heart disease, including ischemic heart disease including MI, angina, arrhythmia, heart failure, valvular disease, and abnormal ECG.
Intervention groups
The intervention group performs two sessions of resistance activity with and without restriction of blood flow; Subjects perform two training protocols in two sessions with an interval of 4 to 6 days. The plan is executed as a cross over.
Main outcome variables
P-selectin, GpIIb / IIIa, Aggregation (ADP), fibrinogen, PT, PTT, hemoglobin PLT, PCT, MPV, and PDW

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130901014540N2
Registration date: 2021-01-04, 1399/10/15
Registration timing: retrospective

Last update: 2021-01-04, 1399/10/15
Update count: 0
Registration date
2021-01-04, 1399/10/15
Registrant information
Name
Elahe Malekyian Fini
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7400
Email address
malekyian.e@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-08-26, 1399/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of resistance exercise and training with blood flow restriction on platelet-activating factors in patients with type 2 diabetes
Public title
The effects of resistance exercise and training with blood flow restriction on platelet-activating factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes should not have heart disease, including ischemic heart disease including MI, angina, arrhythmia, heart failure, valvular disease, and abnormal ECG. These patients should not take more than two types of medication at the same time and should not take insulin. Patients should not take antiplatelet drugs such as aspirin, NSAIDs, and Clopidogrel, have no history of regular exercise, have not performed resistance training in the last six months, and do not have joint disease.
Exclusion criteria:
History of specific infectious and immune diseases, smoking, consumption of alcoholic beverages, dietary supplements and anti-inflammatory drugs, muscle damage and damage to the knee and pelvic joints are the most important factors in the withdrawal of subjects in this research project. Patients with tissue or joint injuries following resistance training are excluded from the research plan.
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of the Medical Ethics Committee of the University of Kashan Medical Science
Street address
Qutb Ravandi Blvd. Holy Defense Bridge, University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
87159-81151
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.KAUMS.REC.1399.035

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
platelet-activating factors
Timepoint
At the beginning of the study, immediately and 30 minutes after the activity
Method of measurement
Flow cytometry is used to measure P-selectin, GpIIb / IIIa.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Exercise group with limited blood flow: Perform light resistance exercise according to the stated protocol with limited blood flow.
Category
Diagnosis

2

Description
Control group: The group of sports activities without blood flow restriction that follows the defined protocol. The protocol is fully described in the abstract section
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
elahe malekyian
Street address
Amirkabir St., Big Fin, Sadat neighborhood, Shafa alley
City
Kashan
Province
Isfehan
Postal code
87187-56771
Phone
+98 31 5530 1113
Email
malekyian.e@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
, Shahid Beheshti University
Full name of responsible person
elahe malekyian
Street address
Amirkabir St., Big Fin, Sadat neighborhood, Shafa alley
City
Kashan
Province
Isfehan
Postal code
87187-56771
Phone
+98 31 5530 1113
Email
malekyian.e@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
, Shahid Beheshti 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
, Shahid Beheshti University
Full name of responsible person
elahe malekyian
Position
Ph.D. Student in Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Amirkabir St., Big Fin, Sadat neighborhood, Shafa alley
City
Kashan
Province
Isfehan
Postal code
87187-56771
Phone
+98 31 5591 2892
Email
malekyian.e@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajad Ahmadizad
Position
Associate Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Sports Sciences, Shahid Beheshti University, Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2290 5848
Email
sahmadizad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Elahe Malekyian Fini
Position
Ph.D. Student in Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Amirkabir St., Big Fin, Sadat neighborhood, Shafa alley
City
kashan
Province
Isfehan
Postal code
87187-56771
Phone
+98 31 5530 1113
Email
malekyian.e@gmail.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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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