Protocol summary
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Study aim
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The purpose of this study to investigate the effect of resistance training on serum levels High Sensitivity-Cardiac Troponin I, N-terminal proBrain Natriuretic Peptid, growth-differentiation factor 15 and The markers of heart damage are in Healthy and diabetic elderly men.
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Design
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This is a semi-experimental study with pretest design with post-test. The statistical population of this study is male elderly men aged 65-78 years old in Karaj. Twenty-four subjects were selected as the sample and randomly divided into two groups of resistance training (12 subjects) and control (12 people)
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Settings and conduct
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At the beginning and the end of the exercises, blood samples are taken. Exercises in the gym are the place for elderly people in Alborz.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: range from 65 to 78 years old.
Exclusion criteria: illness, alcohol and tobacco use, and regular exercise in the past year
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Intervention groups
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Resistance training
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Main outcome variables
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hs-CTnI, NT-proBNP, GDF-15, creatine kinase MB, total creatine kinase, and lactate dehydrogenase are measured in both pre and post training sessions.
General information
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Reason for update
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In the name of God
Given that the Vice Chancellor for Research and Technology of Guilan University of Medical Sciences sent a comprehensive letter to that center to obtain a clinical trial code, I conducted research and sampling on healthy and diabetic elderly people. Unfortunately, I have encountered a problem in publishing the second article related to the section on diabetic elderly people, and the editor of the journal has requested that the words "healthy and diabetic" be added. In addition, given that it was the first time I was registering the research subject information to obtain a clinical trial code, I had completed some parts incompletely, which is currently being corrected. Please instruct the esteemed clinical trial code registrar to change the subject to the following form so that my problem can be resolved (the words "healthy and diabetic" should be added to the end of the subject): "Effects of resistance training on serum levels of hs-CTnI, NT-proBNP, GDF-15 and cardiac injury markers in healthy and diabetic elderly men"
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180819040831N1
Registration date:
2018-09-03, 1397/06/12
Registration timing:
registered_while_recruiting
Last update:
2025-10-25, 1404/08/03
Update count:
1
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Registration date
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2018-09-03, 1397/06/12
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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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2018-08-31, 1397/06/09
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Expected recruitment end date
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2018-11-02, 1397/08/11
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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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The effects of resistance training on serum levels of hs-CTnI, NT-proBNP, GDF-15, and cardiac damage markers in healthy and diabetic elderly men
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Public title
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The effects of resistance training on serum levels of hs-CTnI, NT-proBNP, GDF-15, and cardiac damage markers
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Men aged between 65 and 78 years old
Exclusion criteria:
Have cardiovascular disease
Use tobacco and alcohol
Have been regularly involved in sports activities in the last 1 year
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Age
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From 65 years old to 78 years old
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Gender
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Male
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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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Not randomized
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Randomization description
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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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Single
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Other design features
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Resistance exercises
Ethics committees
1
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Ethics committee
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Approval date
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2025-10-03, 1404/07/11
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Ethics committee reference number
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IR.GUMS.REC
Health conditions studied
1
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Description of health condition studied
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Effects of resistance training on serum levels of hs-CTnI, NT-proBNP, GDF-15 and cardiac injury markers in healthy and diabetic elderly men
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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hs-CTnI
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Timepoint
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Before and after exercise
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Method of measurement
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Human cardiac troponin I(hs-CTnI) (Diasorin Kit)high sensitive
2
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Description
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NT-proBNP
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Timepoint
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Before and after exercise
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Method of measurement
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Human N-terminal pro-brain natriuretic peptide,NT-proBNP, ELISA kit
3
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Description
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Isophorm growth differentiation factor 15
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Timepoint
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Before and after exercise
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Method of measurement
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Human growth differentiation factor 15, ELISA kit
4
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Description
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Creatine kinase type MB
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Timepoint
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Before and after exercise
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Method of measurement
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creatine kinase-myocardial band, kit Pars test
5
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Description
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Total creatine kinase level
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Timepoint
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Before and after exercise
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Method of measurement
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creatine kinase, kit Pars test
6
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Description
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Lactate dehydrogenase
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Timepoint
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Before and after exercise
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Method of measurement
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Using the Pars kit, test lactate dehydrogenase
Secondary outcomes
1
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Description
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Reducing the risk of cardiovascular disease
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Timepoint
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The beginning and end of the exercise
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Method of measurement
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Blood collection using laboratory kits
Intervention groups
1
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Description
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Intervention group: Perform exercises for 8 weeks and 3 sessions per week. The exercise protocol for these people includes 5 minutes of warming (jumping or cycling), the main body of the training and 5 minutes of cool down (stretching). The main motions used are 3 sets with 10 repetitions of 70% 1RM including eight movements of the foot press, forehead, back, leg, chest, boat, arm and arm front. The exercise protocol is a gradual increase in severity and duration for the first two weeks in order to minimize muscle pain and reduce damage. Between each set is one minute and there is a two minute rest between each of the moves. Resistance increases when the subject is able to complete 10 repetitions correctly in the third set for 2 consecutive sessions, and the 1RM at the end of the fourth week is measured and the intensity of the exercise is adjusted in the same way. 48 hours after the last meeting of the protocols in the present study, all measurements of the body composition and biochemical evaluations (in the pre-test) are repeated again.
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Category
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Other
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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Guilan University of Medical Sciences
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Subjects are not satisfied
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable