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

N/AActive Not RecruitingNCT07763795

Superior University60 enrolled

Overview

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.

The objective of this study will be to determine the effect of Blood flow restriction training on peripheral neuropathy in diabetes II patients. The study will be randomized controlled trial. Sample size will be determined by pilot study. The single blinding will be applied. Randomization will be done by lottery method.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Diabetic Neuropathy Peripheral

Interventions

BFR with low resistance high repetition exercisesCOMBINATION_PRODUCT

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

low resistance high repetition exercisesCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * suffers frequent hypoglycaemia, * severe diabetes complications * Diagnosed cases of neuromuscular disorders * history of stroke/DVT

Locations (1)

Sahiwal Diabetes and Foor care Clinic

Sahiwal, Punjab Province, Pakistan

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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."

Time frame: 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.

Time frame: 12 Months

Data from ClinicalTrials.gov

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