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

Sponsor
University of Health Sciences Lahore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06064721
Collaborator
(none)
74
2
4

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Buerger-Allen Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
intervention and control groupintervention and control group
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

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

No Intervention: control group

the control group participants will receive routine care.

Outcome Measures

Primary Outcome Measures

  1. peripheral circulation [total 2 weeks (baseline line, 7th day, 14th day)]

    peripheral circulation measure by Ankle-Brachial Index

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Health Sciences Lahore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sana Zreef, principal investigator, University of Health Sciences Lahore
ClinicalTrials.gov Identifier:
NCT06064721
Other Study ID Numbers:
  • PC RCT 001
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 3, 2023