Effects of BFRT on Glycemic Control, Nerve Conduction, Functional Outcomes and QOL in Individuals With Type 2 Diabetes

NCT07763795 | Active Not Recruiting DMC

• 1 other identifier: PhDRSW/Batch-Fall23/2230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis.

Conditions

Diabetic Neuropathy Peripheral

Outcome Measures

Primary Outcomes (4)

• Glycated Hemoglobin

  HbA1c reflects the average blood glucose concentration over the 3 months by measuring the percentage of hemoglobin that is glycated. Scoring is as following: below 5.7% being normal, 5.7%-6.4% prediabetes, and 6.5% higher diabetes

  12 Months

• Nerve Conduction Velocity

  Nerve conduction velocity measures the speed at which an electrical impulse travels along a peripheral nerve and is used to assess the functional integrity of peripheral nerves. It is particularly useful for detecting and quantifying peripheral nerve dysfunction in diabetic neuropathy. Scoring: NCV is recorded in m/s; typical adult lower reference limits are approximately ≥40-45 m/s for lower-limb motor nerves and ≥40-50 m/s for sensory nerves, with values below the laboratory-specific reference range considered abnormal.

  12 Months

• Numeric pain rating scale (NPRS)

  It is used to assess pain intensity Scoring is as following : its 11-point scale (0-10) 0 means "no pain" and 10 represents "worst possible pain."

  12 Months

• The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument

  The Norfolk QOL-DN measures the impact of diabetic neuropathy on overall health-related quality of life Scoring is as following :Total score of tool is 160. 0-40 score mean Mild or no impairment,41-80 score mean Moderate impairment and 81-160 mean Severe impact on quality of life.

  12 Months

Study Arms (2)

BFR with low resistance high repetition exercises

EXPERIMENTAL

Combination Product: BFR with low resistance high repetition exercises

low resistance high repetition exercises

ACTIVE COMPARATOR

Combination Product: low resistance high repetition exercises

Interventions

BFR with low resistance high repetition exercises COMBINATION_PRODUCT

Three set(30,15,15) with 20% of 1RM(repetition maximum) along with BFR (40% LOP). Rest between sets 60s

BFR with low resistance high repetition exercises

low resistance high repetition exercises COMBINATION_PRODUCT

Three set(30,15,15) with 20% of 1RM(repetition maximum)

low resistance high repetition exercises

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes (≥5 years) patients diagnosed
• random blood glucose ≥ 11.1mmol/L;
• fasting blood glucose ≥ 7.0 mmol/L
• Haemoglobin A1c 6.5%-9.5%. 2) Can walk independently, no severe joint limitations
• Can safely perform resistance training
• Stable diabetic \& neuropathy meds for 3+ months

You may not qualify if:

• suffers frequent hypoglycaemia,
• severe diabetes complications
• Diagnosed cases of neuromuscular disorders
• history of stroke/DVT

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Sahiwal Diabetes and Foor care Clinic

Sahiwal, Punjab Province, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: April 17, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)