Clinical Trials Directory

Trials / Completed

CompletedNCT06064721

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
74 (actual)
Sponsor
University of Health Sciences Lahore · Academic / Other
Sex
All
Age
35 Years – 65 Years
Healthy volunteers
Accepted

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

Detailed description

Peripheral arterial disease is a common complication among patients with Type 2 diabetes mellitus (T2DM), resulting from long-term elevated blood glucose levels that damage blood vessels and impair circulation. This impaired circulation can lead to a range of complications, including poor wound healing, ulcers, and amputations. Peripheral circulation issues, particularly in the lower extremities, are of significant concern as they contribute to decreased mobility, pain, and reduced quality of life in individuals with T2DM. Buerger-Allen exercises are designed to stimulate venous return and enhance limb circulation by alternating between positions of elevation and dependency. This exercise involves different movements to increase blood flow, and improve limb function, ultimately improving quality of life. However, further research is needed to determine the precise impact of this exercise in enhancing lower extremity circulation for individuals with type 2 diabetes mellitus. This study aims to assess the effect of the Buerger-Allen exercise on peripheral circulation among patients with type 2 diabetes mellitus who visited an outpatient 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 will be conducted with 74 participants based on convenience sampling, randomly allocated into two groups (37 in each) through the lottery method. Recruitment for study participants will be conducted in the diabetic clinic of the outpatient department in the district headquarters hospital, Sheikhupura. Peripheral circulation will be assessed using the perfusion index, and Vascular Quality of Life Questionnaire-6 at baseline, on the 6th day, and after 15 days of the intervention. The data will be analyzed using SPSS 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 perfusion index between both groups at different points in time, depending on the normality of data. The significance level will be set at p \< 0.05. It is expected that the intervention group receiving the Buerger-Allen Exercise would demonstrate significant improvements in peripheral circulation, improving quality of life. The findings from the current study may also be substantial for physicians to recommend Buerger-Allen Exercise as adjunctive therapy in individuals with type 2 diabetes mellitus. This evidence-based intervention may also offer accessibility and reduce the need for costly hospitalizations and treatments for peripheral complications of diabetic foot, benefiting both patients and healthcare systems.

Conditions

Interventions

TypeNameDescription
OTHERBuerger-Allen ExerciseBuerger-Allen exercise will be taught by researcher and perform by patient at home twice a day

Timeline

Start date
2025-08-07
Primary completion
2025-11-01
Completion
2025-11-10
First posted
2023-10-03
Last updated
2025-11-20

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT06064721. Inclusion in this directory is not an endorsement.