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IRCT20170120032066N2 IRCT 2018-12-31 Shahroud Unversity of Technology Effect of resistance training on postural control parametes and clinical symptoms in diabetic peripheral neuropathy Effect of resistance training on balance, postural control, risk of fall, reaction time and walking signs of neuropathy in type 2 diabetic patients with peripheral neuropathy - randomized controlled clinical trial 2019-01-05 anticipated 60 Complete https://irct.ir/trial/34765 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be enrolled by one of the research colleagues. An independent evaluator, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study that will be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after enrolled participants completed all baseline assessments. It is impossible to blind the participants and instructor to group allocation but laboratory specialists assessing the variables and data analyst will be blinded to the group allocation. N/A Peripheral Neuropathy Type 2 Diabetes. Intervention 1: Intervention group: Resistance exercise over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum. Intervention 2: Control group: no further activity other than daily physical activity. 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 No decision has been made
public Farhad Gholami
7-Tir Square,. Tehran St.
Shahrood Iran (Islamic Republic of) 3619995161 +98 23 3239 5900 gholami-fa@shahroodut.ac.ir Shahrood University of Technology scientific Farhad Gholami
Tehran St., 7-Tir Square
Shahrood Iran (Islamic Republic of) 3619995161 +98 32395900 gholami-fa@shahroodut.ac.ir Shahroot University of Technology Iran (Islamic Republic of) Age ranges from 30 to 70 years Diagnosis of type 2 diabetes for more than 5 years HbA1c over 6.6% Sedentary life-style No restriction for exercise 30 years 70 years Both E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy Rehabilitation N/A Intervention group: Resistance exercise over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum Control group: no further activity other than daily physical activity Balance index. Timepoint: Before and after the intervention. Method of measurement: Balance will be measured using Tendom test. Risk of falling. Timepoint: Before and after the intervention. Method of measurement: Risk of falling will be assessed with the international questionnaire of falling efficiency. Posture control. Timepoint: Before and after the intervention. Method of measurement: Posture control will be assessed using foot scanner. Reaction time. Timepoint: Before and after the intervention. Method of measurement: Reaction time will be assessed with reaction analyzer. Score of neuropathy symptomes. Timepoint: Before and after the intervention. Method of measurement: Neuropathy score will be assessed using Michigan diabetic neuropathy score. Fasting blood glucose. Timepoint: Before and after the intervention. Method of measurement: Blood glucose level will be measured using Pars-azmoon kit with calorimetric method. Shahroud Unversity of Technology Approved 2018-07-23 Ethics Committee of Shahroud University of Medical Sciences 7-Tir Square., Tehran St. Shahrud Semnan Iran (Islamic Republic of)