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IRCT20210718051924N1 IRCT 2021-08-22 Islamic Azad University The effect of a course of exercise with garlic supplementation on some coagulation factors in middle-aged men with deep vein thrombosis The effect of a six-month combined care program with garlic supplementation on coagulation factors (INR, PTT, PT), Fibrinogen and platelets in middle-aged men with deep vein thrombosis (DVT) 2020-07-22 anticipated 40 Complete https://irct.ir/trial/57569 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the library, field and laboratory methods, measures were taken to collect information about the intervention. After identifying individuals with deep vein thrombosis (DVT) and selecting the research sample, the participants' consent to complete the study was completed. After obtaining the consent to participate in the research, the samples were randomly divided into 4 groups of 10 people: Group 1: Resistance (who performed the designed combined exercises) 2: Garlic consumption group (who consumed garlic according to the plan) 3: Combined exercise with garlic (who did the designed combined exercises and also consumed garlic) 4: Control (did not participate in any of the sports activities) Group 1, 8 weeks, did 3 sessions of combined exercise every week. All exercise programs, starting with the principle of overload, increasingly started from the first week and continued until the end of the eighth week. The experiments were performed in two stages, one day before the first training session (pre-test) and 48 hours after the last training session (post-test) in the eighth week of training, after 10 to 12 hours of fasting. It should be noted that all subjects, in addition to the intervention, continued to take warfarin tablets to the extent prescribed by the doctor for each person during the treatment period, and the amount and timing was determined by each person's doctor. The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down, Blinding description: Both the researcher and the participants. 3 Deep vein thrombosis (DVT). Intervention 1: Intervention group 1: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down. Intervention 2: Intervention group 2: Use of garlic supplement: Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health. Intervention 3: Intervention group 3: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down. Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health. Yes - There is a plan to make this available What will be shared: After the study, I will make the result transparently available for publication in the Islamic Azad University, Kermanshah Branch. When: After the end of the study in early August 2016 To whom: Islamic Azad University, Kermanshah Branch Conditions: To inform patients of deep vein thrombosis treated with warfarin about the risk of blood clots or leg bleeding regarding recovery after using one of these study methods Where to obtain: Hamed Saed How to obtain: The request must be in writing and from the Islamic Azad University of Kermanshah Comments:
public Hamed Saed
No. 24, Shahid Khanmohammadi Fourth Alley, 18 meters from the first street, Jihad Town, Kermanshah
Kermanshah Iran (Islamic Republic of) 6715788638 +98 83 3432 8035 hamedsaed1@yahoo.com Islamic Azad University scientific Hamed Saed
No. 24, Shahid Khanmohammadi Fourth Alley, 18 meters from the first street, Jihad Town, Kermanshah
Kermanshah Iran (Islamic Republic of) 6715788638 +98 83 3432 8035 hamedsaed1@yahoo.com Islamic Azad University Iran (Islamic Republic of) Middle-aged men 40 to 60 years old with deep vein thrombosis (DVT) in Kermanshah 40 years 60 years Male I82.4 Acute embolism and thrombosis of deep veins of lower extremity Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down. Intervention group 2: Use of garlic supplement: Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health. Intervention group 3: Combined exercise (resistance training + aerobic exercise): The combined exercise program was performed for 24 weeks with a frequency of 3 days a week, combining aerobic and resistance exercises. Weight movements in 2 sets and 10 to 12 repetitions will include chest press, wire pull side pull, boat pull, leg press and bending and opening the thigh. Exercises started with 40% of a maximum repetition and lasted 22 minutes. In the aerobic section, the subjects trained for 22 minutes with an intensity of 40% of maximum heart rate (HRmax). At 4 weeks the intensity of the exercises was re-evaluated. At the beginning of the sessions they had 3 to 5 minutes of warm-up time and at the end of 3 to 5 minutes they had time to cool down. Garlic supplement consumption in the present study was 1200 mg daily as one capsule per day and in the control group placebo (1200 mg of starch) was used. The garlic extract was prepared from the American Nature Company with a health license from the General Directorate of Food Supervision of the Ministry of Health. Prothrombin Time (PT)Partial Thromboplastin Time (PTT)International Normalization Ratio (INR), Fibrinogen, platelets. Timepoint: 24 hours before the start of the study and 48 hours after the last training session after 24 weeks. Method of measurement: It was measured by class coagulation method with laboratory kits (ACL) and fully automatic device (ACL 8000 made in Italy). Islamic Azad University Approved 2020-12-22 Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)