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IRCT20161208031300N1 IRCT 2018-05-11 Bojnourd University of Medical Sciences The effect of resistance training and nano curcumin supplementation on synovial fluid biomarkers Study of the effect of resistance training and nano curcumin supplementation on synovial fluid biomarkers in patients with knee osteoarthritis. 2017-12-11 anticipated 60 Complete https://irct.ir/trial/30319 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Other design features: According to our knowledge, to date, there have been very limited studies in the field of resistance training with the use of nanocurcumin supplementation in patients with knee osteoarthritis.Investigating changes in the level of inflammatory and cartilage factors in synovial fluid , we will show a more accurate comparison of the effects of resistance training and the effect of supplementation of nano-corcomin alone and simultaneously, Randomization description: Randomization is done with random numbers, Blinding description: The medication and placebo are coded by the investigator and distributed randomly among the patients.Researchers, clinical caregivers, evaluators, and analysts do not know what type of supplement they are using. 3 Knee Osteoarthritis. Intervention 1: Intervention group:Patients with Knee Osteoarthritis who use nano-curcumin supplementation with resistance training.Exercise groups for 2 months, 3 days a week, knee and hip exercises, including knee extension, pelvic abduction, pelvic edema and plantar flexion, and quadrice chairs, then with a intensity of 50-75% 1RM, will last until the endurance.nano-curcumin supplement of the company Sinacurcumin with a dose of 1000 mg (equivalent to 80 mg of nanosilver), and daily 1, and placebo daily 1(soft gelatin capsule). Intervention 2: Second intervention group : Patients with Knee Osteoarthritis who take a placebo with their resistance training .The training groups will perform for 2 months, 3 days a week, knee and hip exercises, including knee extension, pelvic abduction, pelvic edema and plantar flexion, and quadrice chairs, then with a intensity of 50-75% 1RM until the pressure is tolerated. Placebo. Intervention 3: Third intervention group:Patients with Knee Osteoarthritis that use supplement nano-curcumin.Nanocorcinol supplements are produced by the company Sinacurcumin at a dose of 1000 mg (equivalent to 80 mg Nanosciences) and daily 1 tablet. Intervention 4: Control group: Patients with Knee Osteoarthritis who use one placebo per day. Yes - There is a plan to make this available What will be shared: Information about the main outcome of this study will be shared through the article. When: The start of the access period will be 3 month after the results are printed. To whom: Researchers working in academia and academics and industry professionals Conditions: Terms of use of data or documentation:1. Having specialized knowledge and academic competence in the research subject 2. Present actual research results 3. Failure to remove or modify the original address of the authors of scientific articles 4. Observe the interests of stakeholders at all stages 5. No publication of the results of the plan without coordination and obtaining a license Where to obtain: 1- Dr. Reza Ganji: r.ganji@nkums.ac.ir 2. Dr. Sadegh Cheragh Birjand: s_birjandi2001@yahoo.com How to obtain: Applicants for documentation and data files can apply to the announced email addresses by sending a valid academic and academic application.After verifying the documents submitted, the documents and data files will be provided to the applicants. Comments:
public Farideh Haghighi
Street of the Uprising, No. 322, opposite the Guardian Council
Bojnurd Iran (Islamic Republic of) 9414974877 +98 58 3222 8105 farideh.haghighi.1351@gmail.com Bojnourd University of Medical Sciences scientific Reza ganji
Shahid Mohagher Alley,Shahid Beheshti St, , Research and Technology Dept. of North Khorasan University of Medical Sciences
Bojnurd Iran (Islamic Republic of) 9414974877 +98 58 3229 6966 r.ganji@nkums.ac.ir Bojnourd University of Medical Sciences Iran (Islamic Republic of) Having an OA (primary) knee with a grade of 1 to 4 Low mobility (Participate in sports activities less than three times a week for less than 20 minutes during the past six months and lack of participation in organized activities over the past year) The age range is between 45-60 years Non-acute illness like cardiovascular disease and lack of fracture and injury In the lower extremity or a joint infection Lack of endocrine and metabolic diseases (diabetes, thyroid, kidney, liver), cardiovascular disease (high blood pressure, coronary artery disease and atherosclerosis, peripheral vascular diseases and myocardial infarction), mental illness (depression, Schizophrenia and mania), epilepsy, anemia, cancer and any infectious disease. No history of alcohol and smoking and any addiction 45 years 60 years Female Unwillingness of patients to continue cooperation in research No synovial fluid during aspiration Knee joint limitation and inability to perform sports exercises Any injuries when doing exercises Taking medications other than diclofenac for the treatment of osteoarthritis Suffering from cardiovascular, liver, diabetes, kidney failure Age range less than 45 and more than 60 years Addiction and alcohol and smoking Joint infection M17.0 Primary gonarthrosis, bilateral Treatment - Drugs Rehabilitation Treatment - Drugs Placebo Intervention group:Patients with Knee Osteoarthritis who use nano-curcumin supplementation with resistance training.Exercise groups for 2 months, 3 days a week, knee and hip exercises, including knee extension, pelvic abduction, pelvic edema and plantar flexion, and quadrice chairs, then with a intensity of 50-75% 1RM, will last until the endurance.nano-curcumin supplement of the company Sinacurcumin with a dose of 1000 mg (equivalent to 80 mg of nanosilver), and daily 1, and placebo daily 1(soft gelatin capsule). Second intervention group : Patients with Knee Osteoarthritis who take a placebo with their resistance training .The training groups will perform for 2 months, 3 days a week, knee and hip exercises, including knee extension, pelvic abduction, pelvic edema and plantar flexion, and quadrice chairs, then with a intensity of 50-75% 1RM until the pressure is tolerated. Placebo Third intervention group:Patients with Knee Osteoarthritis that use supplement nano-curcumin.Nanocorcinol supplements are produced by the company Sinacurcumin at a dose of 1000 mg (equivalent to 80 mg Nanosciences) and daily 1 tablet. Control group: Patients with Knee Osteoarthritis who use one placebo per day. Levels of synovial fluid biomarkers of the knee. Timepoint: 24 hours before the intervention and 48 hours after the end of the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay test. Knee pain. Timepoint: 24 hours before the intervention and 24 hours after the intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index,Visual Analogue Scale. Improving the quality of life. Timepoint: 24 hours before the intervention and 24 hours after the intervention. Method of measurement: Health Assessment Questionnaire. Bojnourd University of Medical Sciences Approved 2018-03-13 Ethics Committee of Bojnourd University of Medical Sciences Shahid Mohagher Alley,Shahid Beheshti St, Research and Technology Dept. of North Khorasan University of Medical Sciences Bojnurd North Khorasan Iran (Islamic Republic of)