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

Study Overview
=================
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 in a tertiary care hospital, Lahore. Participants will perform the Buerger -Allen exercise with routine care control group: Researchers will compare with routine care

Detailed 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 and frequency 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 in a tertiary care hospital, Lahore. 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 tertiary care hospital, Lahore. Peripheral circulation will be assessed using the ankle-brachial index (ABI). ABI will be recorded at baseline, on the 7th day, and at the end of the 14th day 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.

Official Title
-----------------
Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus in a Tertiary Care Hospital, Lahore: A Randomized Controlled Trial

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Buerger-Allen Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with Type 2 diabetes mellitus The age group of 35-65 years Patients having Ankle Brachial Index score of less than 0.9 Patients who are using anti-diabetic medications or insulin Patients who easily perform ADL Patients who have never had the same procedure previously Exclusion Criteria: Patients with severe peripheral arterial disease or sudden arterial occlusion Patients with a history of pulmonary embolism or deep vein thrombosis Patients who anticipate pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Buerger-Allen exercise and Routine care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buerger-Allen Exercise Group<br>The researcher will conduct training sessions on the BAE for the study group (how to perform these exercises, duration, and frequency of exercise). Firstly researcher practically demonstrate the BAE technique lasting 15-20 minutes, and secondly will encourage each participant to re-demonstrate the following technique. The researcher will ensure that the study group practices the exercise until they demonstrate competence in its execution. Additionally, the study group will be provided with a photographic brochure illustrating the exercise. The buerger Allen exercise will consist of three steps step 1. Elevation step 2. Dependency step 3. Horizontal The intervention group will continue for 14 days, with a 6-8 hour gap between the two sessions, in addition to receiving routine care. To ensure exercise continuity, participants will receive reminders via phone calls/messages | Other: Buerger-Allen Exercise<br>* Buerger-Allen exercise will be taught by researcher and perform by patient at home twice a day<br>|
| No Intervention: Routine Care Group<br>the control group participants will receive routine care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peripheral circulation | peripheral circulation measure by Ankle-Brachial Index | total 2 weeks (baseline line, 7th day, 14th day) |