Clinical trial NCT06064721: Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 74
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Buerger-Allen exercise and Routine care
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants with Type 2 diabetes mellitus from the last 5 years
* Participants who have an age group of 35-65 years
* Participants who are using anti-diabetic medications or insulin

Exclusion Criteria:

* Participants with a history of deep vein thrombosis
* Patients who have undergone recent surgeries on the lower extremities
* Participants with severe comorbidities, such as uncontrolled hypertension or heart failure
* Participants with cognitive impairments that hinder their ability to understand and perform the exercises safely

Primary outcomes:
measure: peripheral circulation
timeFrame: total 21 days (baseline line, 6th day, and after15th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: