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IRCT20190831044650N2 IRCT 2020-03-18 Qaemshahr branch, Islamic Azad University Effect of 8 weeks of Pilates exercise and vitamin D on Tumor necrosis factor-α and interleukin-10 levels in overweight men Investigating the changes of Tumor necrosis factor-α and Interleukin-10 after 8 weeks of regular Pilates exercise and vitamin D intake in overweight men 2019-12-31 anticipated 56 Complete https://irct.ir/trial/45986 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The subjects will be divided into four groups of control, exercise, vitamin D and exercise + vitamin D using simple randomization table. First a number is assigned to each person. Then, using the random number table of each selected number, it is assigned to one of the groups at random and will continue until the number of individuals in each group is completed. Therefore, the researcher will have no option to change or predict the status of individuals. Random concealment will be done by a third person who does not participate in other stages of intervention, Blinding description: Participants and analysts will be blind. The researcher will administer vitamin D capsules (50,000 units) to vitamin D and exercise + vitamin D individuals as well as placebo to control and exercise groups. N/A Obesity and overweight. Intervention 1: Intervention group 1: Exercise group will perform 8 weeks of Pilates exercises with 50-55% of heart rate reserve, one set and 10 repetitions in the first week and 65-70% reserve heart rate, 4 sets with 12 repetitions in eighth week (with increase A gradual 5% vigorous exercise, one set and 2 reps every two weeks). They will also take a placebo capsule containing oral paraffin weekly in a single blind manner. Intervention 2: Intervention group II: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks in a single blind manner. Intervention 3: Intervention group 3: Subjects in this group will have 8 weeks of Pilates exercises similar to the exercise group and will consume 50,000 IU of vitamin D capsules once a week in a single blind manner. Intervention 4: Control group: There is no intervention in the control group and they are given placebo in a single blind manner. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public masoumeh habibian
7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahr
Qaemshahr Iran (Islamic Republic of) 4765161964 +98 11 4224 1041 habibian_m@yahoo.com Qaemshahr branch, Islamic Azad University scientific masoumeh habibian
7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahrر
Qaemshahr Iran (Islamic Republic of) 4765161964 +98 11 4224 1041 habibian_m@yahoo.com Qaemshahr branch, Islamic Azad University Iran (Islamic Republic of) Being overweight Not having regular exercise for the past six months Ability to perform exercise training Not having cardiovascular disease Not having hypertension 40 years 55 years Male Use of specific drugs Use of supplement smoking E66.0 Obesity due to excess calories Treatment - Other Treatment - Other Treatment - Other Placebo Intervention group 1: Exercise group will perform 8 weeks of Pilates exercises with 50-55% of heart rate reserve, one set and 10 repetitions in the first week and 65-70% reserve heart rate, 4 sets with 12 repetitions in eighth week (with increase A gradual 5% vigorous exercise, one set and 2 reps every two weeks). They will also take a placebo capsule containing oral paraffin weekly in a single blind manner Intervention group II: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks in a single blind manner Intervention group 3: Subjects in this group will have 8 weeks of Pilates exercises similar to the exercise group and will consume 50,000 IU of vitamin D capsules once a week in a single blind manner. Control group: There is no intervention in the control group and they are given placebo in a single blind manner. Tumor necrosis factor-α. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method. 25- hydroxy vitamin D. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method. Interleukin-10. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method. Thyroid Stimulating Hormone. Timepoint: Before and after interventions. Method of measurement: immunochemiluminescence assay. C-Reactive Protein. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method. Insulin. Timepoint: Before and after interventions. Method of measurement: Using the ELISA method. Insulin resistance. Timepoint: Before and after interventions. Method of measurement: Using the homeostasis model(HOMA-IR). Glucose. Timepoint: Prior and after interventions. Method of measurement: Glucose oxidase assay. Urea. Timepoint: Prior and after interventions. Method of measurement: Urease method. Uric acid. Timepoint: Prior and after interventions. Method of measurement: Automatic colorimetric method. Creatinine. Timepoint: Prior and after interventions. Method of measurement: Jaffe methods. Triglyceride. Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Low-density lipoprotein cholesterol (LDL-C). Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. High-density lipoprotein cholesterol (HDL-C). Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Total cholesterol. Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Aspartate aminotransferase. Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Alkaline phosphatase. Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Alanine aminotransferase. Timepoint: Prior and after interventions. Method of measurement: Enzymatic method. Islamic Azad University Qaemshahr Branch Approved 2020-01-14 Ethics Committee of Babol branch, Islamic Azad University Department of physical education, Qaemshahr branch, Islamic Azad University, Qaemshahr, Iran Qaemshahr Mazandaran Iran (Islamic Republic of)