Protocol summary
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Study aim
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The purpose of this study is to investigate the effect of 4 weeks of resistance training on some inflammatory markers in sedentary postmenopausal middle-aged women
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Design
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The study is a randomized clinical trail with control group. 24 obese women (45-55 years, Body mass index 25-35) will be selected through purposive sampling and will randomly be divided into two intervention and control groups
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Settings and conduct
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The present field study is semi-experimental which will be done in a Islamic azad university gym. A professional coach will train the subjects and a lab technetium will take their blood samples. blood sample will be analyzed in the university lab.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria; 45-55 years old women; Body mass index between 25-35. Exclusion criteria: metabolic disorder
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Intervention groups
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Intervention group will do resistance training 3 sessions per week for 4 weeks. Control group will not participate in any exercise.
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Main outcome variables
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CRP-ESR
General information
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Reason for update
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according to ethnic committee certification the word of "sedentary" in title should be changed to overweight as it is showed in below:
effect of a short-term resistance training course on some inflammatory markers of overweight menopausal women
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180822040849N13
Registration date:
2020-08-26, 1399/06/05
Registration timing:
prospective
Last update:
2020-09-14, 1399/06/24
Update count:
1
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Registration date
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2020-08-26, 1399/06/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-22, 1399/08/01
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Expected recruitment end date
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2020-12-05, 1399/09/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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effect of a short-term resistance training course on some inflammatory markers of overweight menopausal women
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Public title
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Resistance Training and Inflammatory Markers in Women
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Purpose
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Basic scienece
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Inclusion/Exclusion criteria
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Inclusion criteria:
age 45-55 years
BMI 25-35 kg/m2
Exclusion criteria:
men
age less than 45 and upper than 55 years
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Age
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From 45 years old to 55 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization by tossing a coin
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-22, 1399/05/01
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Ethics committee reference number
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IR.IAU.SHK.REC.1399.024
Health conditions studied
1
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Description of health condition studied
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overweight
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ICD-10 code
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E66.3
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ICD-10 code description
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Overweight
Primary outcomes
1
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Description
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CRP
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Timepoint
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Before and after 4 weeks resistance training
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Method of measurement
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By ELISA method
2
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Description
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ESR
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Timepoint
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Before and after 4 weeks resistance training
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Method of measurement
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By measurement of Erythrocyte sedimentation rate
Intervention groups
1
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Description
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Intervention group: 12 obese women (45-55 years, BMI 25-35) will participate in this research as intervention group. They will do resistance training 3 sessions per week for 4 weeks. Each exercise session includes 3 workout cycles including 12 stations and 8 to 10 repetition of practice in each station. These stations, respectively, include chest press, leg extension, leg flection, Underhand Cable Pull downs, Barbell Shoulder Press, Barbell Curl, Barbell Triceps, Leg Press, cross with dumbbells, sit-ups, squat, and Barbell incline Bench Press. In the first week, the intensity of the exercise will be 50% of maximum repeat, and in the next weeks, the intensity increase to 85% of maximum repeat. Body mass index measurement and blood sampling will be done in fasting, 24 hours before and 48 hours after the exercise
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Category
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N/A
2
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Description
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Control group: control group will be asked not to participate in any exercise program and keep on their regular diet during research and report any changes in their life like disease, serious stress
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All Data
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When the data will become available and for how long
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6 months after data publication
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To whom data/document is available
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Student and academic staff
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Under which criteria data/document could be used
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every analyses is fine for future research
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From where data/document is obtainable
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Academic papers
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What processes are involved for a request to access data/document
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By sending email to researcher
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Comments
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