Type 2 DiabetesNCT06064721
Effect of Buerger Allen Exercise on Peripheral Circulation Among Patients With Type 2 Diabetes Mellitus
A study testing Buerger-Allen Exercise in people with Type 2 Diabetes, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Buerger-Allen Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Aug 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with Type 2 diabetes mellitus
- Participants who have an age group of 35-65 years
- Participants who are using insulin for the last 5 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Buerger-Allen Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buerger-Allen ExerciseOther
Buerger-Allen exercise will be taught by researcher and perform by patient at home twice a day
| Study group | Role | What they receive |
|---|---|---|
| Buerger-Allen Exercise Group | Experimental | 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 51 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 Receives: Other: Buerger-Allen Exercise |
| Routine Care Group | No intervention | the control group participants will receive routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral circulation
peripheral circulation measure by perfusion index
Measured: total 21 days (baseline line, 6th day, and after15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start7 Aug 2025
- Primary completion1 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Buerger-Allen exercise and Routine care
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Zreef, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064721
- Sponsor's protocol ID
- PC RCT 001
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06064721
- Acronym / sponsor ID
- PC RCT 001
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Buerger-Allen exercise and Routine care
| Arm | Type | Receives |
|---|---|---|
| Buerger-Allen Exercise Group | Experimental | Other: Buerger-Allen ExerciseThe 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 51 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 |
| Routine Care Group | No intervention | –the control group participants will receive routine care. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with Type 2 diabetes mellitus
- Participants who have an age group of 35-65 years
- Participants who are using insulin for the last 5 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buerger-Allen ExerciseBuerger-Allen exercise will be taught by researcher and perform by patient at home twice a day | Other | Buerger-Allen Exercise Group |
Primary outcome
peripheral circulation
Time frame: total 21 days (baseline line, 6th day, and after15th day
peripheral circulation measure by perfusion index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buerger-Allen Exercise in people with Type 2 Diabetes, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peripheral circulation (time frame: total 21 days (baseline line, 6th day, and after15th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.