Protocol summary

Study aim
The present study was designed to see the effect of eight weeks aerobic exercise on endothelin-1, nitric oxide, malondialdehyde, serum 8 hydroxydeoxyguanosine and uric 8 hydroxydeoxyguanosine in elderly women.
Design
Clinical trial with control group, community based and pragmatic, with parallel groups, not blinded care, twenty-one sedentary women were randomly divided into two groups: sedentary control (n=10) and aerobic trained (n=11)
Settings and conduct
This clinical trial study was carried out by designing two experimental and control groups with pretest and post-test in Ferdowsi University of Mashhad
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1- Women aged 60-70 years; 2- Healthy without chronic diseases; 3- Do not do regular exercises in the last six months. Exclusion Criteria: 1- Less than 60 years old or older than 70 years; 2- Having any history of chronic diseases; 3- Doing regular exercise during the last six months.
Intervention groups
Subjects in aerobic training group underwent aerobic training for eight weeks, 3 sessions per week for 45-60 min. Subjects of this group doing aerobic training with intensity of 50-70% HRmax.
Main outcome variables
endothelin-1, nitric oxide, malondialdehyde, serum 8 hydroxydeoxyguanosine and uric 8 hydroxydeoxyguanosine

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120129008863N6
Registration date: 2018-03-15, 1396/12/24
Registration timing: retrospective

Last update: 2018-03-15, 1396/12/24
Update count: 0
Registration date
2018-03-15, 1396/12/24
Registrant information
Name
Keyvan Hejazi
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 1768 6790
Email address
ke_he981@stu-mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-10-26, 1393/08/04
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
2014-10-26, 1393/08/04
Actual recruitment end date
2015-10-23, 1394/08/01
Trial completion date
empty
Scientific title
The effect of eight weeks aerobic exercise on endothelin-1, nitric oxide, malondialdehyde, serum 8 hydroxydeoxyguanosine and uric 8 hydroxydeoxyguanosine in elderly women
Public title
The effect of eight weeks aerobic exercise on endothelin-1, nitric oxide, malondialdehyde, serum 8 hydroxydeoxyguanosine and uric 8 hydroxydeoxyguanosine in elderly women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 60-70 years old Healthy without chronic diseases Do not do regular exercises in the last six months
Exclusion criteria:
Having any history of chronic diseases
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
Actual sample size reached: 21
Randomization (investigator's opinion)
Randomized
Randomization description
Use simple randomization method
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
Ferdowsi University of Mashhad
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad, IRAN
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48979
Approval date
2014-10-26, 1393/08/04
Ethics committee reference number
32123/2

Health conditions studied

1

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

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)

2

Description
Endothelin-1
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)

3

Description
Nitric oxide
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)

4

Description
Serum 8 hydroxydeoxyguanosine
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)

5

Description
Uric 8 hydroxydeoxyguanosine
Timepoint
Eight weeks
Method of measurement
By collecting venous blood before and at the end of study and measuring serum levels of related factors using Enzyme-linked immunosorbent assay (ELISA)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subjects in aerobic training group underwent aerobic training for eight weeks, 3 sessions per week for 45-60 min. Subjects of this group doing aerobic training with intensity of 50-70% HRmax.
Category
Other

2

Description
Control group: Subjects of the control group did not have any regular physical activities during the period of study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Mahdi Ghahremani Moghaddam
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48979
Phone
+98 51 3883 3910
Email
m.ghahremani@um.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Ferdowsi University of Mashhad
Full name of responsible person
Mahdi Ghahremani Moghaddam
Street address
Paradise Daneshgah, Azadi Square, Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48979
Phone
+98 51 3883 3910
Email
m.ghahremani@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Ferdowsi University of Mashhad
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
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Toos Institute of Higher Education
Full name of responsible person
Keyvan Hejazi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Esteghlal Square, Faramarz Abbasi St. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9197913116
Phone
+98 51 3606 3044
Email
keyvanhejazi@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
In order to observe ethical principles in research, personal data and collected data from subjects will remain with the researcher.
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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