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IRCT20210521051357N1 IRCT 2021-07-22 Shahed University The effect of combined exercises with the approach of extreme readiness and coffee consumption on liver enzymes and motor function of middle-aged men with non-alcoholic fatty liver ______________________________________ The effect of eight weeks of independent combined training with coffee consumption on blood lipid profile of middle-aged men with non-alcoholic fatty liver in Covid-19 condition 2021-06-16 anticipated 50 Complete https://irct.ir/trial/56894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Describe how to randomize Random assignment to intervention and control groups In this study, we used the restricted randomization method for all study groups with sample size. We will use the same type of random allocation rule. This method represents a large block for the total sample size, which means that the balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, the sample size (44 people) will be determined first. Then we randomly assign their set to groups A, B and C to the intervention groups (11 people in each group). And group D is for control (11 people). 11 balls (or lottery cards) for each group And we consider a total of 44 numbers.We throw the balls (sheets) into a container and then randomly, the balls (sheets) are taken out of the container without replacement, and the created sequence is recorded. The randomization process is performed by someone outside the study researchers to reduce possible bias.Community Verified icon. N/A Non-alcoholic fatty liver disease. Intervention 1: Intervention group: Intervention group 1: Combined exercise, training intervention will be done 3 sessions per week for 60 minutes. Each session consists of 3 parts of practice, 5 parts. Start the training program by warming up for 10 to 15 minutes. Then the training sections are performed as follows three times without rest: 1- Balance movement for 15 to 20 seconds 2- Aerobic movement for 20 to 30 seconds and with an intensity of 55 to 65% of the maximum heart rate. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Becomes.Subjects rest for 1 to 2 minutes before the start of the next part. Subsequent parts will be performed according to the same procedure and with various movements on other parts of the body. After finishing 3 parts, cooling is done for 5 minutes. Intervention 2: Intervention group: Intervention group 2 combined exercises with coffee consumption, combined exercise intervention 3 sessions per week for 60 minutes. Each session consists of 3 parts of practice, 5 parts. Start the training program by warming up for 10 to 15 minutes. Then the training sections are performed in the following way three times without rest: 1- Balance movement for 15 to 20 seconds 2- Aerobic movement for 20 to 30 seconds and with an intensity of 55 to 65% of the maximum heart rate. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Becomes.Subjects rest for 1 to 2 minutes before the start of the next part. Subsequent parts will be performed according to the same procedure and with various movements on other parts of the body. After finishing 3 parts, cooling is done for 5 minutes. And the coffee consumption intervention coincides with the days of the training intervention (once an hour before the training intervention) in the morning between 9 and 11 o'clock and in the afternoon between 15 and 17 o'clock a cup (180 c) C) Indonesian robusta coffee is consumed in the form of cherry and Java and medium roast with a degree of softness of / 5 in the form of Turkish coffee. The required dose of coffee is 10 grams per serving (the amount of caffeine in the sample is between 215 to 235 mg per serving is 180 cc). Intervention 3: Intervention group: Intervention group 3 Coffee consumption, Coffee consumption intervention on a daily basis and in coordination with intervention days Training between 9 am and 11 am and in the afternoon between 3 pm and 5 pm Medium degree of softness of 5 / is consumed in the form of Turkish coffee. The required dose of coffee is 10 grams per serving. (The amount of caffeine in the sample is between 215 to 235 mg per serving of 180 cc). Intervention 4: Control group: Intervention group 4 Controls do not receive any intervention. Yes - There is a plan to make this available What will be shared: Information on the main outcomes studied Possibility of subscription Has a transition. When: The data are available after the publication of all the results obtained Will take Community Verified icon To whom: Only for researchers working in academic and scientific institutions Conditions: The study or proposal protocol should be submitted by the Ethics Committee of the institution or university To be approved. The rights of authors and their sponsors must be protected Be Where to obtain: Talireza099@gmail.com or alireza.taheri@shahed.ac.ir How to obtain: This request must be addressed to the Vice Chancellor for Research and Technology of Shahed University of Tehran and will be done with the information of the project manager Comments:
public Alireza Taheri Dilatabadi
No. 5, Morvarid Alley, East 16, Shahid Motahari St.
Dolatabadi Iran (Islamic Republic of) 8341856813 +98 31 4582 1250 Talireza099@gmail.com Shahed University scientific Nahid Talebi
No,1, in front of the Imam Khomeini Shrine, The free end of the Persian Gulf road, Shahed University
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 5080 talebi@shahed.ac.ir Shahed University Iran (Islamic Republic of) Middle-aged men 30 to 60 years Grade 1, 2 and 3 liver disease People with high blood lipid profiles People without cardiovascular disease People without physical disabilities 30 years 60 years Male Men over 60 years old People with fatty liver disease grade 4 People with physical disabilities People with heart failure People with lung disease K76.0 Fatty (change of) liver, not elsewhere classified N/A N/A N/A N/A Intervention group: Intervention group 1: Combined exercise, training intervention will be done 3 sessions per week for 60 minutes. Each session consists of 3 parts of practice, 5 parts. Start the training program by warming up for 10 to 15 minutes. Then the training sections are performed as follows three times without rest: 1- Balance movement for 15 to 20 seconds 2- Aerobic movement for 20 to 30 seconds and with an intensity of 55 to 65% of the maximum heart rate. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Becomes.Subjects rest for 1 to 2 minutes before the start of the next part. Subsequent parts will be performed according to the same procedure and with various movements on other parts of the body. After finishing 3 parts, cooling is done for 5 minutes. Intervention group: Intervention group 2 combined exercises with coffee consumption, combined exercise intervention 3 sessions per week for 60 minutes. Each session consists of 3 parts of practice, 5 parts. Start the training program by warming up for 10 to 15 minutes. Then the training sections are performed in the following way three times without rest: 1- Balance movement for 15 to 20 seconds 2- Aerobic movement for 20 to 30 seconds and with an intensity of 55 to 65% of the maximum heart rate. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Pilates largely avoids high impact, high power output, and heavy muscular and skeletal loading. Becomes.Subjects rest for 1 to 2 minutes before the start of the next part. Subsequent parts will be performed according to the same procedure and with various movements on other parts of the body. After finishing 3 parts, cooling is done for 5 minutes. And the coffee consumption intervention coincides with the days of the training intervention (once an hour before the training intervention) in the morning between 9 and 11 o'clock and in the afternoon between 15 and 17 o'clock a cup (180 c) C) Indonesian robusta coffee is consumed in the form of cherry and Java and medium roast with a degree of softness of / 5 in the form of Turkish coffee. The required dose of coffee is 10 grams per serving (the amount of caffeine in the sample is between 215 to 235 mg per serving is 180 cc). Intervention group: Intervention group 3 Coffee consumption, Coffee consumption intervention on a daily basis and in coordination with intervention days Training between 9 am and 11 am and in the afternoon between 3 pm and 5 pm Medium degree of softness of 5 / is consumed in the form of Turkish coffee. The required dose of coffee is 10 grams per serving. (The amount of caffeine in the sample is between 215 to 235 mg per serving of 180 cc) Control group: Intervention group 4 Controls do not receive any intervention Serum levels of hepatic alanine transaminase and aspartate transaminase enzymes. Timepoint: Measurement three days before the start of the study intervention. Method of measurement: Blood test to determine the serum levels of alanine transaminase and aspartate transaminase liver enzymes is performed by BT 2500 analyzer and 3000 rpm centrifuge for 5 minutes with Behdad device made in Iran and standard kits of Par Azmoon company. Liver grade. Timepoint: Measurement three days before the start of the study intervention. Method of measurement: Liver grade with ultrasound device from Samsung Korea WS80A model. Blood lipid profile. Timepoint: Measurement three days before the start of the study intervention. Method of measurement: Blood test to determine the amount of blood lipid profile is measured by BT 2500 analyzer and 3000 rpm centrifuge in 5 minutes with Behdad device made in Iran and standard kits of Par Azmoon company. Motor function. Timepoint: Measurement three days before the start of the study intervention. Method of measurement: Motor function is performed by fitness tests (sit-ups, steps, stork balance, quadratic agility, and Welsh flexibility). Decreased hepatic alanine transaminase and aspartate transaminase enzymes. Timepoint: Measurement three days after the end of the study. Method of measurement: Blood test is done to determine the serum levels of the liver enzymes alanine transaminase and aspartate transaminase. Decreased liver grade. Timepoint: Measurement three days after the end of the study. Method of measurement: Liver grade with ultrasound device from Samsung Korea WS80A model. Decreased blood lipid profile. Timepoint: Measurement three days after the end of the study. Method of measurement: Blood sample to determine the amount of blood lipid profile by BT 2500 analyzer and 3000 rpm centrifuge in 5 minutes with Behdad machine made in Iran and standard kits of Pars Azmoon company. Increase motor performance. Timepoint: Measurement three days after the end of the study. Method of measurement: Motor function is performed by physical fitness tests (sitting position, step test, quadratic agility, stork balance and flexibility). Shahed University Approved 2020-10-27 Ethics of Shahed University of Tehran No,1,in front of the Imam Khomeini Shrine ,The free end of the Persian Gulf road, Shahed University Tehran Tehran Iran (Islamic Republic of)