Comparing the effectiveness of Leg Ergometry exercises with and without WB-EMS on blood sugar regulation in patients with type II diabetes

Comparison of the effectiveness of leg ergometry exercises with and without WB-EMS on blood glucose regulation in patients with type II diabetes in Imam Khomeini Hospital, Sari, in 2023

Clinical trial with control group, with parallel groups, double-blind, randomized, on 30 patients. SNOSE will be used for randomization.

Imam Khomeini Hospital, Sari, patients with type II diabetes will be included in the study according to the entry and exit criteria. In the clinical trial study, the SNOSE method will be used to hide (blinding) the random allocation.

Entry conditions: patients with type II diabetes, age 30 to 70 years, consent to participate in the study, 7<HbA1C<10, no exogenous insulin use, BMI>25, no heart pacemaker and defibrillator, no heart failure Symptomatic and uncontrolled exclusion conditions: lack of consent to participate in the study, withdrawal from participation in the study, absence of more than 2 sessions, presence of new diabetic foot ulcers or musculoskeletal defects, pregnant women, breastfeeding, presence of serious orthopedic, neurological or infectious disorders (joint Charcot, diabetic foot ulcer, amputation), uncontrolled seizures

1) Patients receiving aerobic exercise by Leg Ergometry along with EMS 2) Patients receiving aerobic exercise by Leg Ergometry method without receiving EMS. The exercise that each patient receives is Leg Ergometry or stationary bicycle, which is performed for 30 minutes in the group without EMS and 20 minutes in the group with EMS. 3 sessions per week for 8 weeks of this training protocol will be done

Blood sugar level

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.

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.