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IRCT20261011071374N1 IRCT 2026-10-30 Shahid Beheshti University of Medical Sciences The effects of resistance training on diabetic neuropathy Comparison of the effects of strength and muscular endurance resistance training in patients with diabetic neuropathy 2026-11-16 anticipated 34 Pending https://irct.ir/trial/94044 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a randomized clinical trial with two parallel groups: A resistance strength training group and a resistance muscular endurance training group, with 17 participants allocated to each group. The unit of randomization is the individual participant, and allocation will be performed using block randomization. The random allocation sequence will be generated using the online tool Research Randomizer and will be designed to ensure that, at the end of the allocation process, 17 participants are assigned to each group. No stratified randomization will be used.The generation of the random allocation sequence and the preparation of allocation envelopes will be carried out by an individual associated with the research who is independent of the informed consent process, data collection, and implementation of the exercise intervention. To conceal allocation, the group assignments will be placed in opaque, externally non-transparent, sealed envelopes bearing consecutive numbers. After eligibility criteria have been verified and written informed consent has been obtained from each participant, the envelope corresponding to that participant will be opened according to the sequential numbering, and the allocated group will be revealed. Thus, the person responsible for participant recruitment and enrollment will not know the group assignment before the allocation takes place, preventing the next assignment from being predicted. After the group assignment has been revealed, the corresponding intervention will be implemented. N/A Condition 1: Type one Diabetic neuropathy. Condition 2: Type two Diabetic neuropathy. Intervention 1: Intervention group 1: Strength Resistance Training; Participants will perform supervised strength resistance training twice a week for 8 weeks. Exercise intensity will start at 50% of the one-repetition maximum (1RM) and will be gradually increased according to each participant’s individual ability, physical condition, and progress, potentially reaching up to 90% of 1RM. Reaching the target intensity will not be mandatory for all participants. Exercise intensity will be adjusted individually, and participants’ training performance and progression will be monitored throughout the intervention. Intervention 2: Intervention group 2: Muscular Endurance Resistance Training; Participants will perform supervised muscular endurance resistance training twice a week for 8 weeks. Exercise intensity will start at 30% of the one-repetition maximum (1RM) and will be gradually increased according to each participant’s individual ability, physical condition, and progress, potentially reaching up to 40% of 1RM. Reaching the target intensity will not be mandatory for all participants. Exercise intensity will be adjusted individually, and participants’ training performance and progression will be monitored throughout the intervention. Yes - There is a plan to make this available What will be shared: All data are available for sharing. When: Access will be provided after publication of the results. To whom: Researchers at academic and scientific institutions Conditions: For use in university research projects. Where to obtain: University Research Vice-Chancellery How to obtain: Visit the university’s research website and submit an access request. Comments:
public Pardis Sadeqi
Ayatollah Taleghani Hospital, Shahid Arabi Street, Velenjak, Tehran
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 pardissadeqi1994@gmail.com Shahid Beheshti University of Medical Sciences scientific Pardis Sadeqi
Ayatollah Taleghani Hospital, Shahid Arabi Street, Velenjak
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 2560 Pardissadeqi1994@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of diabetic neuropathy Age between 18 and 75 years Written informed consent to participate in the study Fasting blood glucose (FBS) greater than 120 and less than 250 mg/dL Blood pressure between 60/70 and 140/90 mmHg HbA1c level between 6.5% and 8.5% 18 years 75 years Both Presence of autonomic neuropathy Presence of non diabetic neuropathy Current tobacco use Diagnosis of rheumatoid arthritis History of surgery within the past month Presence of significant motor impairment or edema in the lower extremities History of limb amputation Presence of an active foot ulcer Presence of significant limitations in joint range of motion History of orthopedic surgery or presence of significant musculoskeletal disorders that interfere with the proper performance of the exercise protocol Presence of hemiparesis, tremor, or other movement disorders that interfere with the performance of exercises or study assessments Presence of vestibular disorders that affect balance and motor function Presence of significant central nervous system dysfunction Presence of significant peripheral nervous system or vascular disorders that may affect study outcomes or the safety of exercise performance Presence of cardiac disease that medically contraindicates or renders resistance training unsafe Presence of deep vein thrombosis Use of medications specifically prescribed for the treatment of diabetic neuropathy, except vitamin B1,thiamine; and other supplements permitted under the study protocol Presence of underlying metabolic abnormalities that may affect study outcomes, including anemia, magnesium deficiency, or vitamin B12 deficiency E10.42 E11.42 Type 1 diabetes mellitus with diabetic polyneuropathy Type 2 diabetes mellitus with diabetic polyneuropathy Rehabilitation Rehabilitation Intervention group 1: Strength Resistance Training; Participants will perform supervised strength resistance training twice a week for 8 weeks. Exercise intensity will start at 50% of the one-repetition maximum (1RM) and will be gradually increased according to each participant’s individual ability, physical condition, and progress, potentially reaching up to 90% of 1RM. Reaching the target intensity will not be mandatory for all participants. Exercise intensity will be adjusted individually, and participants’ training performance and progression will be monitored throughout the intervention. Intervention group 2: Muscular Endurance Resistance Training; Participants will perform supervised muscular endurance resistance training twice a week for 8 weeks. Exercise intensity will start at 30% of the one-repetition maximum (1RM) and will be gradually increased according to each participant’s individual ability, physical condition, and progress, potentially reaching up to 40% of 1RM. Reaching the target intensity will not be mandatory for all participants. Exercise intensity will be adjusted individually, and participants’ training performance and progression will be monitored throughout the intervention. Change in the Michigan Neuropathy Screening Instrument (MNSI) score. Timepoint: At baseline (before the intervention) and at the end of week 8 (after completion of the intervention). Method of measurement: The Michigan Neuropathy Screening Instrument, including the symptom questionnaire and physical examination, together with the monofilament test to assess protective sensation, the tuning fork test to assess vibration sensation, and clinical examination of the limbs. Shahid Beheshti University of Medical Sciences Approved 2026-10-11 Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran Ayatollah Taleghani Hospital, Shahid Arabi Street, Yaman Street, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)