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The Effect of Aerobic Training on Level of Serum Troponin I , CK-MB ,Glycemic Indices and Lipid Profile in Type 2 Diabetes Women

Protocol summary

Study aim
The aim of this study was to evaluate the effect of aerobic exercise on serum levels of troponin I, creatine kinase MB and glycemic index and fat profile in women with type 2 diabetes.
Design
Clinical trial has two groups (control and intervention ), one blind, simple randomization on 30 diabetic
Settings and conduct
The present study was performed on the effect of exercise on cardiac indices, glycemic index and fat profile in Najafabad city with 30 women with type 2 diabetes aged 30 to 50 years randomly selected. The method of blinding is a blind spot. Information that can distort the test result is hidden from the participant, but only the researcher is aware of it. Including: type of intervention, training protocol, sampling method and grouping method. Groups included: experimental group of 15 diabetic women participating in aerobic exercise and control group including: 15 diabetic women who did not have any regular exercise. Intervention: Aerobic exercises performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate.
Participants/Inclusion and exclusion criteria
Diabetic women 30 to 50 years old Type 2 diabetic. Having diabetes more than three years, treated only with oral medications and non insulin injections, etc. not having Sports Activity regular physical, at least the last 6 months and lacks any disease affecting .Lack of smoking, alcohol, caffeine and medicine . Not having heart disease and blood pressure.
Intervention groups
The experimental group consisted of 15 diabetic women participating in moderate intensity aerobic exercises and the control group consisted of 15 diabetic women who had no regular exercise activities.
Main outcome variables
Changes in fasting blood sugar, glycosylated hemoglobin, troponin I CK-MB, and lipid profile

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200803048287N1
Registration date: 2020-09-28, 1399/07/07
Registration timing: retrospective

Last update: 2020-09-28, 1399/07/07
Update count: 0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Batol Amini Najafabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4264 7809
Email address
amini12445522@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2019-12-01, 1398/09/10
Actual recruitment start date
2019-11-28, 1398/09/07
Actual recruitment end date
2019-12-25, 1398/10/04
Trial completion date
2020-02-27, 1398/12/08
Scientific title
The Effect of Aerobic Training on Level of Serum Troponin I , CK-MB ,Glycemic Indices and Lipid Profile in Type 2 Diabetes Women
Public title
Effect of Exercise on Heart, Blood sugar and Lipid Profile
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the Age Range of 50 to 30 Years. Diabetes was Based on the Criteria of the World Health Organization. Having Diabetes more than Three Years. Treatment only with Medicines Edible and non Insulin Injections not having Sports Activity Regular Physical, at Least the Last 6 Months Not affecting any of the diseases (including history of cardiovascular disease, history of heart surgery) on research variables No smoking, alcohol, caffeine
Exclusion criteria:
History of cardiovascular disease, history of heart surgery Have regular physical activity for at least the last 6 months
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 18
Actual sample size reached: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used to assign samples to each group. For this purpose, we use random allocation software and select the block alloc ation method. The software categorizes numbers into two groups by assigning them to people. The researcher then divides the people into two groups according to the output list.Random aliocation software was used for this purpose. In the software we specify the number of blocks (2 blocks) then the software gives us a list that randomly, the samples are assigned to two groups. Samples are selected based on that.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants in each group did not know about other people and their treatment plan. People in each group are called in for tests on different days. Also, the clinical caregiver who is responsible for recording test results and clinical descriptions does not know which group this person belongs to. In addition, the data is entered in such a way that the treatment and control groups are marked with letters. The statistician cannot be informed about the group of people during the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Groups included: Experimental or intervention group: 15 diabetic women participating in moderate-intensity aerobic exercise and control group: 15 diabetic women who did not engage in regular exercise. Interventions: The subjects in the control group did not do any exercise. In the intervention group, the exercise program included aerobic exercises that were performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Islamic Azad University-Najafabad Branch
Street address
No. 3/22, Shadan dead end, Shahram alley, Amirkabir street,
City
Najaf Abad
Province
Isfehan
Postal code
8514763493
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1399.083

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Troponin I
Timepoint
To measure troponin I in 3 times: 1- Pre-test 2- Six hours after the first exercise 3- Six hours after the last exercise session.
Method of measurement
Troponin I was measured using a monobind kit and Dynex device and Eliza method. The normal range in this method is up to 0.3 ng / ml.

2

Description
Creatine Kinase MB
Timepoint
In 3 times: 1- Pre-test 2- Twelve hours after the first training session 3- Twelve hours after the last training session.
Method of measurement
Immuno inhibition was performed using the Biosystem kit and the BA400 autoanalyzer. The normal range in this method is up to 24 U / L.

3

Description
Fasting blood sugar
Timepoint
After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session)
Method of measurement
Glucose Oxidase was performed using Biosystem kit and BA400 autoanalyzer.

4

Description
Glycosylated hemoglobin A1C
Timepoint
After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session)
Method of measurement
Immuno turbid metric was performed using Axzshzld kit and BA400 autoanalyzer.

5

Description
Fat profile (lipid profile)
Timepoint
After 12 hours of overnight fasting in the pre-test, and in the post-test (48 hours after the last training session)
Method of measurement
It was performed using the biosystem company kit and with BA400 autoanalyzer and peroxidase method.

Secondary outcomes

1

Description
Troponin I
Timepoint
To measure troponin I in 3 times: 1- Pre-test 2- Six hours after the first exercise 3- Six hours after the last exercise session.
Method of measurement
Troponin I was measured using a monobind kit and Dynex device and Eliza method. The normal range in this method is up to 0.3 ng / ml.

2

Description
Creatine Kinase MB
Timepoint
To measure CK-MB in 3 times: 1- Pre-test 2- Twelve hours after the first training session 3- Twelve hours after the last session
Method of measurement
CK-MB was measured using Biosystem kit and BA400 autoanalyzer by Immuno inhibition method. The normal range in this method is up to 24 U / L.

Intervention groups

1

Description
Intervention group: 15 diabetic women participating in moderate intensity aerobic exercise. Intervention: Exercise program including aerobic exercise that was performed for 8 weeks, 3 (sessions per week). Moderate-intensity aerobic exercise, including walking, was performed at 55 to 75 percent of maximum heart rate. These exercises were performed for 150 minutes per week and each session lasted 50 minutes. The warm-up program included 10 minutes of warm-up in the form of jogging, combined arm and leg movements, and stretching exercises. Performing aerobic exercises, the first two weeks 35 and once every two weeks, observing the principle of gradual overload, 5 minutes were added to the training time, and when returning to the initial state, 10 minutes of cooling movements were allocated. Exercises were performed in a gym at a temperature of 25 degrees Celsius
Category
Lifestyle

2

Description
Control group: 15 diabetic women who did not have any regular exercise.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Janan Diabetes Center in Najafabad
Full name of responsible person
Ayub Shapoori
Street address
Opposite Shahid Anari Alley, Danesh St., Shariati St.
City
Najafabad
Province
Isfehan
Postal code
8513794791
Phone
+98 31 4246 0640
Email
janan.ansar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The organization has not supported
Full name of responsible person
Batool Amini Najafabadi
Street address
No. 22/3, Shadan dead end, Shahram alley, Amirkabir street
City
Najafabad
Province
Isfehan
Postal code
8514763493
Phone
+98 31 4264 7809
Email
amini12445522@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The organization has not supported
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Education Najafabad
Full name of responsible person
Batool Amini Najafabadi
Position
Secretary of Education
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 22/3, Shadan dead end, Shahram alley, Amirkabir street,
City
Najafabad
Province
Isfehan
Postal code
8514763493
Phone
+98 31 4264 7809
Email
amini12445522@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Education Najafabad
Full name of responsible person
Batool Amini Najafabadi
Position
Secretary of Education Najafabad
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 22/3, Shadan dead end, Shahram alley, Amirkabir street,
City
Najafabad
Province
Isfehan
Postal code
8514763493
Phone
+98 31 4246 7809
Email
amini12445522@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Education Najafabad
Full name of responsible person
Batool Amini Najafabadi
Position
Secretary of Education Najafabad
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 22/3, Shadan dead end, Shahram alley, Amirkabir street,
City
Najaf Abad
Province
Isfehan
Postal code
8514763493
Phone
+98 31 4246 7809
Email
amini12445522@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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