Protocol summary

Summary
the aim of the present study was to investigate the effect of 4 weeks of aerobic training on coagulation and fibrinolytic factors activity levels in untrained young men. 20 subjects were selected for this semi-experimental study and randomly divided into two groups including experimental (n=10) and control (n=10) groups. Inclusion criteria were no history of chronic diseases. Experimental group, participated in a program of aerobic exercise (3 days a week for 4 weeks). The control group did not participate in any physical activity and continued their daily activities. Before and 24 hours after the last training session, Body weight, BMI and coagulation factors such as, fibrinogen, Protrombin Time, Partial Thromboplastin Time and platelet count and also D-dimer fibrinolytic factors were measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102624717N1
Registration date: 2016-01-03, 1394/10/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Ehsan Mir
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 17 3544 0186
Email address
ehsanmir@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research ferdowsi University of mashhad
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
clinical trial The effect of four weeks aerobic training on blood coagulation and fibrinolytic factors in untrained young men
Public title
Effect of training on fibrinogen levels
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Healthy young men with no previous record of any specific drug use؛ without experience of regular physical activity in two year before beginning of the study. Exclusion Criteria: Unhealthy؛ Doing regular exercise during the last two years.
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, randomized was performed using sealed envelopes.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Azadi Square, Mashhad
City
Mashhad
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
11722

Health conditions studied

1

Description of health condition studied
Cardiovascular risk factor and inflammatory markers
ICD-10 code
I70
ICD-10 code description
Atherosclerosis

Primary outcomes

1

Description
plasma fibrinogen
Timepoint
Before and 24 hr after intervention
Method of measurement
Enzymatic Method

Secondary outcomes

1

Description
Body Mass Index
Timepoint
Before and 24 hr after intervention
Method of measurement
By body composition analyzer machine

Intervention groups

1

Description
Intervention 1: Participating in aerobic training in 4 weeks, 3 times a week, 30 to 35 minutes each session
Category
Other

2

Description
Control group: Control groups were without training over four weeks
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sezavar Clinic of Mashhad City
Full name of responsible person
Majid Sezavar
Street address
Aref Street, Ahmadabad Street, Mashhad, Khorasan-e-Razavi Province
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ferdowsi University of Mashhad
Full name of responsible person
Mehrdad Fathi
Street address
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Azadi Square, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ferdowsi University of Mashhad
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Mehrdad Fathi
Position
Assistant Professor in Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Azadi Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3880 5000
Fax
Email
Ehsanmir90@yahoo.com; Ehsanmir1990@gmail.com; Ehsanmir@stu.um.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ehsan Mir
Position
Master of Science in Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Azadi Square, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3880 5000
Fax
Email
Ehsanmir90@yahoo.com; Ehsanmir1990@gmail.com; Ehsanmir@stu.um.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Ehsan Mir
Position
Master of Science in Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Azadi Square, Mashhad
City
Mashhad
Postal code
Phone
+98 91151311800
Fax
Email
Ehsanmir90@yahoo.com; Ehsanmir1990@gmail.com; Ehsanmir@stu.um.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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