Protocol summary

Summary
Introduction: The aims of this study is to investigate the Effects of Resistance Exercise Training on IL-6 ,TNF-α , hsCRP, GH, IGF-1, Estrogen, Adiponectin, Resistin, Insulin resistance and Balance in Postmenopausal Women with Knee Osteoarthritis. Methodology: The statistical population of this study consists of women with knee osteoarthritis selects purposefully and randomly will be divided in control (n=10) and resistance exercise training (n=11) groups. The subjects will be performed resistance exercise training 8 to 12 times with an intensity of 60 – 80% of one of their maximum repetition for a period of 12 weeks, three sessions a week (45 minutes each). Correlated t-test will use for determining within group differences and independent t-test for determining between groups differences, respectively. Data will be analyzed at less than 0.05.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061428406N2
Registration date: 2016-07-04, 1395/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-04, 1395/04/14
Registrant information
Name
Akbar Azamian Jazi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 983814424411
Email address
azamian-a@lit.sku.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Resistance Exercise Training on IL-6,TNF-α, hsCRP, GH, IGF-1, Estrogen, Adiponectin, Resistin, Insulin resistance and Balance in Postmenopausal Women with Knee Osteoarthritis
Public title
Effects of Resistance Exercise Training on Postmenopausal Women with Knee Osteoarthritis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: knee arthritis; pain on > 50 % of days in the month in one or both knees; difficulty with activities of daily living due to knee pain; X-ray documenting knee OA within 1 year prior to study entry; 15 lbs to 50 lbs overweight. Exclusion criteria: significant cardiac, pulmonary, renal, or hepatic disease; major psychiatric diseases; ACR functional class IV; structured exercise more than once per week for 20 minutes or longer during the 3 months prior to study entry; anticipates moving from the area within 18 months of study entry; anticipates undergoing knee surgery within 1 year of study entry; weight loss of more than 5 kg (11 lbs) in 3 months prior to study entry; anorexiant or other medications known to affect metabolism; current or planned pregnancy.
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahrekord University
Street address
Shahrekord University, kiloometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Approval date
2013-09-16, 1392/06/25
Ethics committee reference number
190/746

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Arthrosis of knee

Primary outcomes

1

Description
TNF-α
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

2

Description
IL-6
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

3

Description
Resistin
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

4

Description
hsCRP
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

5

Description
Adiponectin
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

6

Description
Insulin Resistance
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

7

Description
GH
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

8

Description
IGF-1
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

9

Description
Estrogen
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Elisa Kit

10

Description
Balance
Timepoint
Before and after 12 weeks of resistance exercise training
Method of measurement
Standard test for balance

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group: The subjects performed resistance exercise training 8 to 12 times with an intensity of 60 – 80% of one of their maximum repetition for a period of 12 weeks, three sessions a week.
Category
Lifestyle

2

Description
Control group: The control group received no exercise intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati and Alzahra Hospital
Full name of responsible person
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
Mohammad Faramarzi
Street address
Vice President of Research, Shahrekord University, kiloometr 2 jadeh Saman, Shahrekord, Iran
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University
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
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate Professor)
Other areas of specialty/work
Street address
Shahrekord University, kiloometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate Professor)
Other areas of specialty/work
Street address
Shahrekord University, kiloometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate Professor)
Other areas of specialty/work
Street address
Shahrekord University, kiloometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.com
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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