Diabetic Neuropathy Peripheral
Conditions
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTBFR with low resistance high repetition exercises
Three set(30,15,15) with 20% of 1RM(repetition maximum) along with BFR (40% LOP). Rest between sets 60s
COMBINATION_PRODUCTlow resistance high repetition exercises
Three set(30,15,15) with 20% of 1RM(repetition maximum)
Sponsors
Superior University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | 12 Months | 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 |
| Nerve Conduction Velocity | 12 Months | 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. |
| Numeric pain rating scale (NPRS) | 12 Months | 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." |
| The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument | 12 Months | 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. |
Countries
Pakistan
Outcome results
None listed