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IRCT20201128049511N6 IRCT 2024-01-16 University of Tarbiat Modares The effect of whole body vibration on patients with diabetic sarcopenia Investigating the effect of whole body vibration on muscle mass, biomechanical parameters and metabolic factors in diabetic patients with sarcopenia 2024-01-20 anticipated 60 Complete https://irct.ir/trial/74017 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in this study will be done by block randomization method. Participants will be randomly assigned into intervention or control groups. The size of blocks will be 4. Also, the blocks will be randomly placed in the envelopes. For random assignment, code 1 denotes the intervention group and code 0 denotes the control group in the envelopes. Subjects will choose an envelope and then, based on the chosen code, they are assigned to one of the groups. N/A Condition 1: Sarcopenia. Condition 2: Type 2 diabetes. Intervention 1: Intervention group: The intervention consists of 12 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 12 weeks, 5 to 12 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis. Intervention 2: Control group: This group will not receive any vibration and the subjects will be evaluated before and after 12 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared when the subjects be made unidentifiable. When: The access phase starts six months after the results publication To whom: Researchers in academic and research organizations will have access to the data. Conditions: To do scientific research Where to obtain: Sahar Boozari, Adress: Tarbiat Modares University; Jalal Al Ahmad Highway; Email: s.boozari@modares.ac.ir; Phone number: 00982182885053 How to obtain: After sending the project plan and a complete evaluation of the persons and organizations involved in the project, the data will be sent following the approval. Comments:
public Motahare Ababaf Behbahani
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5053 m.behbahani@modares.ac.ir The University of Tarbiat Modares scientific Sahar Boozari
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 5053 s.boozari@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) At least 6 months history of diabetes Diagnosis of sarcopenia in people with diabetes Score less than 13 on Michigan Neuropathy Screening Instrument 60 years 80 years Both Having thyroid disorders GFR score above 30 History of acute ischemia such as infarction in less than 3 months History of falling in the past year Taking drugs and supplements that have known effects on the neuromuscular system (such as corticosteroids) M62.84 E11 Sarcopenia Type 2 diabetes mellitus Treatment - Other Other Intervention group: The intervention consists of 12 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 12 weeks, 5 to 12 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis. Control group: This group will not receive any vibration and the subjects will be evaluated before and after 12 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. Ground Reaction Force Parameters. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Force plate device. Quality of Life Index. Timepoint: Before and after 12 weeks of interventions. Method of measurement: SarQoL questionnaire. Parameters of the body sway. Timepoint: قبل و بعد از 12 هفته مداخله. Method of measurement: Force plate. Body mass parameters. Timepoint: قبل و بعد از 12 هفته مداخله. Method of measurement: DXA. Muscle strength. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Dynamometer. Lipid profile. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Blood test. Fasting blood sugar(FBS). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Blood test. Glycated hemoglobin (A1C). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Blood test. Inflammation factors. Timepoint: Before and after 12 weeks of intervention. Method of measurement: Blood test. Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences University of Tarbiat Modares Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences Approved 2023-11-26 Ethics committee of Tarbiat Modares University Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway Tehran Tehran Iran (Islamic Republic of)