Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06064721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-09-26
Brief Title:
Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus
Sponsor:
University of Health Sciences Lahore
Organization:
University of Health Sciences Lahore
Study Overview
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 dayafter 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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None