Comparing the effects of strength-oriented and endurance-oriented resistance training on clinical outcomes in patients with diabetic neuropathy
Design
A randomized clinical trial with two parallel groups. A total of 34 participants will be randomly allocated to either the strength resistance training group or the muscular endurance resistance training group using Research Randomizer software.
Settings and conduct
This trial compares strength- and endurance-oriented resistance training in patients with diabetic neuropathy at the Sports Medicine Clinic, Loghman Hakim Hospital, during 2026–2027. Participants and trainers cannot be blinded due to the intervention; outcome assessors and the statistician will be blinded to allocation, and groups will be coded for analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of diabetes with diabetic neuropathy, medical eligibility for resistance training, and provision of informed consent. Exclusion criteria: Presence of autonomic neuropathy; Presence of non diabetic neuropathy; Current tobacco use; Diagnosis of rheumatoid arthritis; History of surgery within the past month
Intervention groups
Intervention Group 1 (Resistance Strength Training): Twice-weekly training for 8 weeks, starting at 50% of one-repetition maximum (1RM), with 8–12 repetitions per set, progressively increasing to 90% of 1RM according to individual tolerance.Intervention Group 2 (Resistance Endurance Training): Twice-weekly training for 8 weeks, starting at 30% of 1RM, with 12–20 repetitions per set, progressively increasing to 40% of 1RM according to individual tolerance.
Main outcome variables
One-Repetition Maximum (1RM); Michigan score (MNSI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20261011071374N1
Registration date:2026-10-30, 1405/08/08
Registration timing:prospective
Last update:2026-10-30, 1405/08/08
Update count:0
Registration date
2026-10-30, 1405/08/08
Registrant information
Name
Pardis sadeqi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1406
Email address
pardissadeqi1994@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-16, 1405/08/25
Expected recruitment end date
2027-01-13, 1405/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of strength and muscular endurance resistance training in patients with diabetic neuropathy
Public title
The effects of resistance training on diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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%
Exclusion criteria:
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran
Type 1 diabetes mellitus with diabetic polyneuropathy
2
Description of health condition studied
Type two Diabetic neuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Pardis Sadeqi
Street address
Loghman Hakim Hospital, Kamali Street, South Kargar Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 936 170 3013
Email
Pardissadeqi1994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Research Deputy Office, 3rd Floor, Shahid Beheshti University of Medical Sciences, Near Taleghani Hospital, Arabi Street, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pardis Sadeqi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Ayatollah Taleghani Hospital, Shahid Arabi Street, Velenjak, Tehran