search
Back to results

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

Primary Purpose

Peripheral Circulatory Disorder Due to Type 2 Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buerger-Allen Exercise
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Circulatory Disorder Due to Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    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

    the control group participants will receive routine care.

    Outcomes

    Primary Outcome Measures

    peripheral circulation
    peripheral circulation measure by Ankle-Brachial Index

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    September 26, 2023
    Sponsor
    University of Health Sciences Lahore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06064721
    Brief Title
    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 in a Tertiary Care Hospital, Lahore: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Circulatory Disorder Due to Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    intervention and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    the control group participants will receive routine care.
    Intervention Type
    Other
    Intervention Name(s)
    Buerger-Allen Exercise
    Intervention Description
    Buerger-Allen exercise will be taught by researcher and perform by patient at home twice a day
    Primary Outcome Measure Information:
    Title
    peripheral circulation
    Description
    peripheral circulation measure by Ankle-Brachial Index
    Time Frame
    total 2 weeks (baseline line, 7th day, 14th day)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs