Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title: Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus Visited in Outpatients Department: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This randomized control trial aims to compare peripheral circulation in type 2 diabetes mellitus. This study aims to determine the effect of the Buerger-Allen exercise (BAE) on peripheral circulation among patients with type 2 diabetes mellitus visited in outpatients department Participants will perform the Buerger -Allen exercise with routine care control group: Researchers will compare with routine care

Clinical Trial Description

Peripheral circulation issues are a significant concern in individuals with type 2 diabetes (T2DM) primarily affecting the legs and feet, potentially leading to diabetic foot complications. Buerger-Allen exercise is designed to enhance blood circulation in the extremities, especially in the lower limbs, and is commonly used to address issues like peripheral artery disease (PAD) and diabetic foot complications. This exercise involves different movements to increase blood flow, alleviate discomfort, and improve limb function, with the ultimate goal of preventing or mitigating circulation-related complications. However, further research is needed to determine the precise impact of this exercise in enhancing lower extremity perfusion for individuals with type 2 diabetes mellitus who have a notable high prevalence of 58% in peripheral arterial disease. This study aims to determine the effect of the Buerger-Allen exercise (BAE) on peripheral circulation among patients with type 2 diabetes mellitus visited in outpatients department. It is hypothesized that patients who will receive the Buerger-Allen exercise will have a difference in peripheral circulation than patients who will not. A randomized controlled trial (RCT) will be conducted with 74 participants based on convenience sampling, randomly allocated into two groups (37 in each group) through the lottery method. Recruitment for the study participants will be conducted in a diabetic clinic of the outpatients department in district headquarter hospital Sheikhupura. Peripheral circulation will be assessed using the ankle-brachial index (ABI). ABI will be recorded at baseline, on the 6th day,after 15 days and after 1 month of intervention period. The data will be analyzed by SPSS using version 27. Descriptive statistics (percentage, frequency, mean, and standard deviation) will be used to describe the characteristics of the study population. Inferential statistics such as independent t-tests and repeated measures ANOVA will be used to compare the mean score of ABI between both groups at different points in time, depending on the normality of data. In cases where the data is not normally distributed, the Mann-Whitney U test and the Friedman test will be applied. The significance level will be set at p < 0.05. The result of this study anticipated that the intervention group receiving the Buerger-Allen exercise would demonstrate significant improvements in peripheral circulation and can be recommended as adjunctive therapy to improve peripheral circulation in individuals with type 2 diabetes mellitus. This evidence-based intervention offers accessibility and may reduce the need for costly hospitalizations and treatments for peripheral complications of diabetic foot, benefiting both patients and healthcare systems. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT06064721
• Study type: Interventional
• Source: University of Health Sciences Lahore
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: September 1, 2024