Design and settings
T1DM, cardiac autonomic neuropathy, hypoglycemia, diabetic, diabetes
HYPOGLYCEMIA, CARDIAC AUTONOMIC NEUROPATHY, SIDE EFFECT, DIABETES
This randomized paralleled controlled trial was conducted between February 2019 and June 2019 on children with T1DM aged 8–14 years who visited 17-Shahrivar Children’s Hospital, Iran. The study was approved by the Ethics Committee of Islamic Azad University of Rasht, Iran, under the ethics approval code of IR.IAU.RASHT.REC.1398.011. It was also registered in the Iranian Registry of Clinical Trials under the code of IRCT20150531022498N30: Participants were recruited to the study if they met the following inclusion criteria: (1) pediatric T1DM, (2) glycosylated hemoglobin (Hb A1c) ≥ 7, (3) age 8–14 years, and (4) duration of diabetes for at least 1 year.The exclusion criteria were severe hypoglycemia (< 50 mg/Dl), unconsciousness, and cardiac autonomic neuropathy. The participants who were absent for more than 5 sessions were excluded from the research as well. All the participants included in the randomization process (20 in the exercise group and 20 in the control group) completed the study and no participants dropped out.The randomization process was done based on the red and blue balls inside the box that were randomly taken by the participants (the Red Orb and the Blue Orb of the experimental and control group). This process was supervised by an independent researcher. The control group had no exercise. The participants had to follow the dietary recommendations throughout the study. Dietary intakes were assessed using a 3-day food record (two weekdays and one weekend) at the baseline and the end of the study in both groups. Dietary recommendations were made with an emphasis on the use of a variety of foods (e.g., whole grains, fat-free, fruits, vegetables, poultry, fish, and nuts).To find out the tolerance of the exercise method by the subjects and to define sample size, the training protocol was first applied in a pilot study on five male and female patients with T1DM for 2 weeks. These patients were not included in the final sampling. In the end, they showed mild symptoms, like sourness, because the training was initiated at a low intensity. Therefore, no intolerable side effect was noted. The results revealed that the training protocol can be executed on diabetic patients aged 8–14 years.