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IRCT20221120056558N1 IRCT 2023-05-31 Kerman University of Medical Sciences Determining the combined effect of MitoQ supplementation and endurance training on cognitive and motor functions, changes in oxidative indices and miR-223 and miR-146a gene expression in postmenopausal and non-menopausal women with multiple sclerosis Determining the combined effect of MitoQ supplementation and endurance training on cognitive and motor functions, changes in oxidative indices and miR-223 and miR-146a gene expression in postmenopausal and non-menopausal women with multiple sclerosis 2023-06-05 anticipated 120 Complete https://irct.ir/trial/67041 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: In this experimental study, 120 women in the age group between 18 and 65 years old with MS of type RRMS (recurrence and improvement) were randomly selected and divided into eight groups (n=15), Blinding description: In this study, the clinical supervisor and the data analyst were blinded, so that it is not clear which groups will receive the supplement and which groups will receive the placebo. 3 Multiple sclerosis. Intervention 1: The first intervention group: non-menopausal women receiving MitoQ supplement. MitoQ supplement is an advanced antioxidant made by MitoQ company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Intervention 2: The second intervention group: non-menopausal women receiving MitoQ supplement and exercise program. MitoQ supplement is an advanced antioxidant manufactured by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Training sessions: including eight weeks of training (each session 30 minutes and three times a week) will be done by Monark (Leg ergometer) bicycle, the training intensity is based on 65-75% of maximum heart rate and maximum oxygen consumption. VO2Peak) is set. (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Intervention 3: The third intervention group: non-menopausal women receiving a placebo and an exercise program. The placebo will be used every morning on an empty stomach for two months. Exercise sessions: including eight weeks of exercise (30 minutes each session and three times a week) by Monark bicycle work meter (Leg ergometer) will be done, the training intensity is adjusted based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak). (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Intervention 4: Control group: non-menopausal women without receiving supplements and exercise program. Intervention 5: The fourth intervention group: menopausal women receiving MitoQ supplement. MitoQ supplement is an advanced antioxidant manufactured by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Intervention 6: The fifth intervention group: menopausal women receiving MitoQ supplement and exercise program. MitoQ supplement is an advanced antioxidant made by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Training sessions: including eight weeks of training (each session 30 minutes and three times a week) will be done by Monark bicycle (Leg ergometer), training intensity based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak) ) is set. (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Intervention 7: The sixth intervention group: menopausal women receiving a placebo and exercise program. The placebo will be used every morning on an empty stomach for two months. Training sessions: including eight weeks of training (30 minutes each session and three times a week) by bicycle. Monark work meter (Leg ergometer) will be done, exercise intensity is adjusted based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak). (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Intervention 8: Control group: menopausal women without supplements and exercise program. Yes - There is a plan to make this available What will be shared: In this study, only information related to the main outcome is accessible When: Access to information will only be in the form of printed articles To whom: Professors, Doctors (neurologists) and Students Conditions: Access to information will only be in the form of printed articles Where to obtain: Access to information will only be in the form of printed articles How to obtain: Access to information will only be in the form of printed articles Comments:
public Atena Alifarsangi
Alley No. 2, South Shahid Ebrahimi St., Sayad Shirazi Blvd
Kerman Iran (Islamic Republic of) 7616185659 +98 34 3341 1651 alifarsangi.atena@yahoo.com Kerman University of Medical Sciences scientific Dr. Rostam Saif Aldini
Shafa St., Islamic Republic Blvd., Shafa Hospital
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5786 r.seifaddini@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Diagnosis of MS by a neurologist Being in remission (at least 2 months after the last relapse) EDSS score less than 6 No acute attacks within 30 Last day Continuing to take MS drugs Not taking medicine for fatigue No taking drugs 18 years 65 years Female People with cardiovascular, liver and kidney diseases People with diabetes Having any skeletal-muscular disorders and obvious congenital anomalies Having obvious visual impairments Having certain diseases such as cancer People with mental disabilities Treatment - Other Treatment - Other Placebo Other Treatment - Other Treatment - Other Placebo Other The first intervention group: non-menopausal women receiving MitoQ supplement. MitoQ supplement is an advanced antioxidant made by MitoQ company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. The second intervention group: non-menopausal women receiving MitoQ supplement and exercise program. MitoQ supplement is an advanced antioxidant manufactured by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Training sessions: including eight weeks of training (each session 30 minutes and three times a week) will be done by Monark (Leg ergometer) bicycle, the training intensity is based on 65-75% of maximum heart rate and maximum oxygen consumption. VO2Peak) is set. (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). The third intervention group: non-menopausal women receiving a placebo and an exercise program. The placebo will be used every morning on an empty stomach for two months. Exercise sessions: including eight weeks of exercise (30 minutes each session and three times a week) by Monark bicycle work meter (Leg ergometer) will be done, the training intensity is adjusted based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak). (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Control group: non-menopausal women without receiving supplements and exercise program The fourth intervention group: menopausal women receiving MitoQ supplement. MitoQ supplement is an advanced antioxidant manufactured by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. The fifth intervention group: menopausal women receiving MitoQ supplement and exercise program. MitoQ supplement is an advanced antioxidant made by MitoQ Company in New Zealand. This supplement will be used every morning on an empty stomach with a dose of 20 mg for two months. Training sessions: including eight weeks of training (each session 30 minutes and three times a week) will be done by Monark bicycle (Leg ergometer), training intensity based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak) ) is set. (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). The sixth intervention group: menopausal women receiving a placebo and exercise program. The placebo will be used every morning on an empty stomach for two months. Training sessions: including eight weeks of training (30 minutes each session and three times a week) by bicycle. Monark work meter (Leg ergometer) will be done, exercise intensity is adjusted based on 65-75% of maximum heart rate and maximum oxygen consumption (VO2Peak). (Each training session will include 5 minutes of warm-up, 20 minutes of main training with training intensity and target heart rate, and 5 minutes of cooling down to 40% of maximum heart rate.). Control group: menopausal women without supplements and exercise program Serum estrogen levels. Timepoint: Estrogen hormone will be measured at the beginning of the study (before the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: ELISA KIT. Serum progesterone levels. Timepoint: Progesterone hormone will be measured at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: ELISA KIT. Serum levels of reactive oxygen species (ROS). Timepoint: The measurement of ROS will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Eliza kit (spectroscopy). Serum level of total antioxidant capacity (TAC). Timepoint: The measurement of TAC will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Eliza kit (spectroscopy). Serum level of glutathione peroxidase (GPx). Timepoint: GPx will be measured at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Eliza kit (spectroscopy). Malondialdehyde (MDA) serum level. Timepoint: The measurement of MDA will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Eliza kit (spectroscopy). MicroRNA gene expression (miR-146a). Timepoint: The measurement of miR-146a will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Real time PCR. MicroRNA gene expression (miR-223). Timepoint: The measurement of miR-223 will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Real time PCR. Measuring psychological function (determining the severity of depression symptoms). Timepoint: The depression level will be measured at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Beck Depression Questionnaire. Measuring psychological function(fatigue). Timepoint: Fatigue will be measured at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Fatigue Severity Scale Questionnaire (FSS). Measurement of motor function (balance). Timepoint: The balance measurement will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Berg Balance Scale. Measuring cognitive performance (memory, attention). Timepoint: Memory measurement will be at the beginning of the study (before the start of the intervention) and 60 days (two months) after the start of the supplement and exercise program. Method of measurement: Bicams test. Kerman University of Medical Sciences Approved 2022-10-23 Ethics Committee of Kerman University of Medical Sciences Afzalipur Hospital., Imam Blvd Kerman Kerman Iran (Islamic Republic of)