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A comparison of the effects of 12 weeks walking with two different intensities on the expression of circulating miR-146a and miR-181a and Plasma levels of inflammatory markers IL-6 and TNF-α In Sedentary Aged Women.

Protocol summary

Study aim
A comparison of the effects of12-week walking with moderate and high intensities on circulating miR-146a and miR-181a, plasma levels of inflammatory markers IL-6, TNF-α, WBC, some performance indicators and cardio-respiratory endurance in sedentary aged women
Design
Randomized clinical trial with control group, non blinded, with parallel groups
Settings and conduct
Among women 60-70 years old and inactive in Karaj, thirty volunteers woman will be selected as the study population and randomly divide into three group: moderate intensity walking, high intensity walking and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inactive women aged 60 to 75 years; Exclusion criteria: have any inflammatory and cardiovascular diseases, certain medication or nutritional status and motor disability
Intervention groups
The first intervention group: 12 weeks walking, 3 sessions per week, with a moderate intensity of 55-50% maximum heart rate reserve(HRRmax) The second intervention group: 12 weeks walking, 3 sessions per week with a high intensity of 75-70% HRRmax The third intervention group: Untrained control group with no intervention
Main outcome variables
Circulating levels of miR-146a and miR-181a, plasma levels of IL-6 and TNF-α, white blood cell counts, static balance, dynamic balance, body composition, cardio respiratory endurance, and the quality of life of elderly women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N23
Registration date: 2018-07-06, 1397/04/15
Registration timing: registered_while_recruiting

Last update: 2018-07-06, 1397/04/15
Update count: 0
Registration date
2018-07-06, 1397/04/15
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effects of 12 weeks walking with two different intensities on the expression of circulating miR-146a and miR-181a and Plasma levels of inflammatory markers IL-6 and TNF-α In Sedentary Aged Women.
Public title
A comparison of the effects of 12 weeks walking with two different intensities on the expression of circulating miR-146a, miR-181a and Plasma levels of inflammatory markers IL-6 and TNF-α In Sedentary Aged Women.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women Age range 60 to 75 Inactive
Exclusion criteria:
Having any chronic and inflammatory disease Having any particular diet or medication during the study period Use of auxiliary equipment for walking Motor limitation in the pelvic, hip and knee joints
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were divided into 3 groups (one control group and 2 experimental groups) using the random numbers table
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 Rasht Azad University
Street address
lbn Sina St, District 4, Rasht., Gilan Province.
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1396.93

Health conditions studied

1

Description of health condition studied
Diseases associated with aging and inflammation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma level of miR-146a
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using by polymerase chain reaction (PCR)

2

Description
Plasma level of microRNA-181a
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using by polymerase chain reaction (PCR)

3

Description
Plasma level of Interleukin-6
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Serum level using ELISA Kit

4

Description
Plasma level of Tumor necrosis factor alpha (TNF-α)
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Serum level using ELISA Kit

5

Description
White blood cell counts
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using blood sample

Secondary outcomes

1

Description
Blood pressure variables
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Rest levels using by measurement of systolic blood pressure, diastolic blood pressure and heart rate

2

Description
Quality of life
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using by quality of life questionnaire (SF-36)

3

Description
Body composition
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using by measurement of weight, body mass index (BMI), fat percent, fat free mass and waist circumference

4

Description
Physical fitness
Timepoint
Before and after the end of 12 weeks of training
Method of measurement
Using by measurement of dynamic and static balance and maximum oxygen consumption (VO2max)

Intervention groups

1

Description
The first Intervention group: moderate intensity of walking, In this group, the subjects will be walking(55-50% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 50% of the maximum heart rate reserved and in the second six weeks it will be 55%.
Category
Rehabilitation

2

Description
The second Intervention group: High intensity of walking,In this group, the subjects will be walking(70-75% of the target heart rate) for 12 weeks and 3 sessions in a week. The workout time of the first week will begin at 30 minutes and will increase to 45 minutes at the end of the sixth week. The intensity of exercise in the first six weeks will be 70% of the maximum heart rate reserved and in the second six weeks it will be 75%.
Category
Rehabilitation

3

Description
Control group: Without any intervention, subjects in this group will continue their normal routine during the 12-week study period.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Setayesh gym in Alborz Province
Full name of responsible person
Katayon Tehrani
Street address
No. 9, East Baghestan Ave., Shahin Vila Blvd., Karaj Town
City
Alborz
Province
Alborz
Postal code
3193974999
Phone
+98 26 3446 4681
Email
fatemefalah1363@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht Azad University
Full name of responsible person
Farhad Rahmaninia
Street address
Ibn Sina St, District 4, Rasht., Gilan Province.
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
frahmani2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Rasam university of Alborz province
Full name of responsible person
Fateme Falah
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Imam Khomeini Squ,.Baghestan St,. Alborz province
City
Alborz
Province
Alborz
Postal code
3193747846
Phone
+98 26 3452 4701
Email
fatemefalah1363@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Fateme Falah
Position
The Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Ibn Sina St, District 4, Rasht., Guilan Province.
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
fatemefalah1363@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Rasht
Full name of responsible person
Fateme Falah
Position
The Student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Ibn Sina St, District 4, Rasht., Guilan Province.
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
fatemefalah1363@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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