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IRCT20210901052353N1 IRCT 2024-03-02 Mazandaran University of Medical Sciences Comparing the effectiveness of Leg Ergometry exercises with and without WB-EMS on blood sugar regulation in patients with type II diabetes Comparing the effectiveness of Leg Ergometry exercises with and without WB-EMS on blood sugar regulation in patients with type II diabetes 2024-03-09 anticipated 30 Complete https://irct.ir/trial/75248 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation by the method of variable blocks. In this study, the randomization method will be used to generate a random sequence using the block method and the Random allocation software. First, the informed consent form is registered by the patient in writing, and then the participants will be randomly assigned to each group, Blinding description: SNOSE method will be used to hide random allocation. This method is one of the common methods in hiding random allocation. In this method, a random sequence is first created using the mentioned software, then based on the sample size of a number of envelopes with aluminum wrappers (in order to make the contents of the envelopes unclear), prepare and each of the random sequences created on It is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of the registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed. N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: Patients receiving aerobic exercise by Leg Ergometry along with EMS. Intervention 2: Control group: Patients receiving aerobic exercise by Leg Ergometry without receiving EMS. 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 There is no further information
public Seyed Ali Akbar Mohammadi
Amir Mazandarani Boulevard, Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 001133361700 amahmoudi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Seyed Ali Akbar Mohammadi
Amir Mazandarani Boulevard, Imam Khomeini Hospital
Sari Iran (Islamic Republic of) 48166-33131 001133361700 amahmoudi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with type II diabetes Age 30 to 70 years Consent to participate in the study HbA1C<10>7 No use of exogenous insulin BMI>25 Absence of pacemaker and defibrillator Not having symptomatic and uncontrolled heart failure Absence of psychiatric disorders No history of CVA, MI, Unstable angina in the last month Not having uncontrolled HTN 30 years 70 years Both Lack of consent to participate in the study Withdrawal from participating in the study Absence of more than 2 sessions Presence of new diabetic foot ulcer or musculoskeletal defects pregnant lady breastfeeding Presence of serious orthopedic, neurological or infectious disorders (Charcot's joint, diabetic foot ulcer, amputation) Uncontrolled seizures Severe proliferative and non-proliferative diabetic retinopathy Change in dosage and type of oral medication E11 Type 2 diabetes mellitus Treatment - Devices Treatment - Devices Intervention group: Patients receiving aerobic exercise by Leg Ergometry along with EMS Control group: Patients receiving aerobic exercise by Leg Ergometry without receiving EMS Blood sugar decreasing. Timepoint: At the beginning and before entering the study and at the end of week 8. Method of measurement: blood test. Oxygen consumption capacity or aerobic capacity per person. Timepoint: At the beginning and before entering the study and at the end of week 8. Method of measurement: Field test. Mazandaran University of Medical Sciences Approved 2023-12-17 Ethics Committee of Mazandaran University of Medical Sciences, Imam Khomeini Hospital, Sari Amir Mazandarani Boulevard, Imam Khomeini Hospital Sari Mazandaran Iran (Islamic Republic of)