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NCT Number: NCT07842237

Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy.

Chemotherapy-induced peripheral neuropathy (CIPN) and impaired lower-limb circulation are common adverse effects that can compromise patients' mobility, comfort, balance, functional independence, and quality of life and may increase the risk of falls. Although Buerger-Allen exercises and mechanical compression therapy are non-pharmacological approaches that may improve peripheral circulation and alleviate neuropathic symptoms, evidence directly comparing these interventions among patients receiving chemotherapy remains limited, particularly in Egypt. This study will address this gap and may inform feasible, nurse-led strategies for supportive oncology care.

Aim of the study:

This study will aim to compare the effects of Buerger-Allen exercises and mechanical compression therapy on lower-limb perfusion and peripheral neuropathy among patients undergoing chemotherapy.

Randomized control trail research design will be used. Setting The study will be conducted in the inpatient chemotherapy department at Ayady Almostakbal Cancer Treatment Hospital, Alexandria Governorate, Egypt. The hospital is a specialized, non-governmental, charitable medical center that provides cancer treatment services to residents of Alexandria Governorate and surrounding areas.

Subjects:

A purposive sample of 100 eligible patients will be recruited and allocated equally to two intervention groups: the Buerger-Allen exercise group (n = 50) and the mechanical compression therapy group (n = 50).

Inclusion criteria:

• Adult male and female patients aged 20-60 years who have been receiving chemotherapy for at least six months and who are willing to participate will be eligible for inclusion.

Exclusion criteria:

* Patients with uncontrolled diabetes mellitus or other medical conditions that may affect lower-limb perfusion or peripheral nerve function will be excluded. * Patients with burns or extensive wounds of the lower limbs will be excluded. * Patients with a lower-limb amputation will be excluded. * Patients receiving another physical, pharmacological, or mechanical treatment regimen directed at the lower limbs will be excluded.

Tools for data collection:

Two principal assessment tools will be used for data collection.

Tool 1: Lower-Limb Perfusion Assessment. This tool will be developed by the researchers following a comprehensive review of the relevant literature and will consist of three parts:

* Part I: Patient Demographic Profile. This part will be used to collect data on age, gender, educational level, marital status, and occupation. * Part II: Clinical Data. This part will be used to assess the patient's past and current health history. * Part III: Lower-Limb Perfusion Assessment. This part will be adapted from Abouelala et al. (2022) Tool 2: Peripheral Neuropathy Assessment. This tool will be adapted from Abouelala et al. (2022) Proposed Study Procedures * The tools will be evaluated for content validity and relevance by a panel of five experts in medical-surgical nursing and oncology. Their recommendations will be considered when preparing the final versions. * A pilot study will be conducted with 10% of the calculated sample to assess the clarity, feasibility, and applicability of the study tools and procedures. Necessary modifications will be made accordingly. Participants included in the pilot study will be excluded from the main study sample and analyses. * Patients who meet the eligibility criteria will be allocated equally to the Buerger-Allen exercise group (n = 50) and the mechanical compression therapy group (n = 50). * Written informed consent will be obtained from each participant after the study purpose, intervention procedures, potential risks, and expected

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Polyneuropathies Lower Extremity Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Regional Blood Flow

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damanhour University

Damanhūr, Damanhur, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male and female patients aged 20-60 years who have been receiving chemotherapy for at least six months and who are willing to participate will be eligible for inclusion.

Exclusion criteria

  • Patients with uncontrolled diabetes mellitus or other medical conditions that may affect lower-limb perfusion or peripheral nerve function will be excluded.
  • Patients with burns or extensive wounds of the lower limbs will be excluded.
  • Patients with a lower-limb amputation will be excluded.
  • Patients receiving another physical, pharmacological, or mechanical treatment regimen directed at the lower limbs will be excluded.

Treatment and study plan

mechanical compression therapy

Device
  • Participants in Group 2 will receive mechanical compression therapy once during each chemotherapy session for one month, for a total of three sessions, with each session lasting 20 minutes.

Exercises

Other

Buerger-Allen exercises. The researchers will explain and demonstrate the exercise and will ask each participant to return-demonstrate the following three steps:

  • Step 1-Elevation: The participant's lower extremities will be elevated to approximately 45° and supported in this position until blanching occurs, for approximately three minutes.
  • Step 2-Dependency: The participant's feet and legs will then be lowered below the level of the body until redness appears, for approximately 10 minutes.
  • Step 3-Horizontal rest: The participant's legs will be placed flat on the bed for 10 minutes.
  • The three-step Buerger-Allen exercise cycle will be repeated three times per session. Participants will be instructed to complete three sessions per day for five consecutive days, with performance monitored and reinforced by the researchers.

Primary outcomes

  1. Change in lower-limb circumference measured using a non-stretch measuring tape

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Lower-limb circumference will be measured in centimeters using a non-stretch measuring tape at the mid-thigh, calf, and above the ankle of each lower limb. The same anatomical landmark and procedure will be used at every assessment. A lower circumference may indicate reduced swelling or edema. Right- and left-limb measurements will be recorded separately.

  2. Change in lower-limb skin temperature assessment by palpation using the back of the fingers

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Lower-limb skin temperature will be assessed by palpation using the back of the fingers. Measurements will be recorded separately for the right and left lower limbs.

  3. Change in lower-limb capillary refill time assessed by the blanching test

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Capillary refill time will be assessed by applying pressure to the distal toe until blanching occurs and measuring the time required for normal color to return after pressure is released. The result will be recorded in seconds. A shorter capillary refill time indicates better peripheral perfusion. Each lower limb will be assessed separately.

  4. Change in distal pedal pulse strength assessed using a standardized pulse-grading scale

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Dorsalis pedis and posterior tibial pulse strength will be assessed by palpation and graded as 0 = absent, 1 = weak, 2 = normal, and 3 = bounding. Higher scores indicate stronger palpable distal pulses. Each pulse site and lower limb will be documented separately.

  5. Change in lower-limb edema assessed using the pitting-edema grading scale

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Pitting edema will be assessed by applying standardized pressure over the lower limb and grading the resulting indentation using a 0-4+ scale, where 0 indicates no pitting edema and 1+ to 4+ indicate increasing severity. Higher scores indicate more severe edema. Each lower limb will be assessed separately.

  6. Change in active ankle dorsiflexion measured using a goniometer

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Active ankle dorsiflexion will be measured using a standard goniometer while the participant actively moves the ankle through the available range. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater active range of motion.

  7. Change in passive ankle dorsiflexion measured using a goniometer

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Passive ankle dorsiflexion will be measured using a standard goniometer while the assessor moves the participant's ankle through the available range without active effort from the participant. The angle will be recorded separately for the right and left ankles. A greater angle indicates a greater passive range of motion.

Secondary outcomes

  1. lower-limb sensation assessed using the adapted Peripheral Neuropathy Assessment Tool

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Lower-limb sensation will be assessed using the sensation component of the researcher-adapted Peripheral Neuropathy Assessment Tool based on Abouelala et al. (2022) including light touch, pinprick, vibration. Each lower limb will be assessed separately at prespecified anatomical sites using the standardized procedures and response categories defined in the finalized assessment tool. Sensation will be classified as intact or impaired. The outcome will be reported as the number of participants with impaired lower-limb sensation.

  2. lower-limb pain intensity assessed using the Numeric Rating Scale

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Participants will rate lower-limb pain intensity on a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less pain. If both limbs are painful, pain will be assessed separately for each limb or according to a prespecified rule identifying the most symptomatic limb.

  3. lower-limb skin color assessed by standardized clinical inspection

    Time frame: Baseline, immediately after completion of the assigned intervention, and at 2 and 4 weeks after intervention completion

    Lower-limb skin color will be assessed by standardized clinical inspection and classified using prespecified categories in the Lower-Limb Perfusion Assessment, such as normal color, pallor, cyanosis, or dependent rubor. The outcome will be reported as the number of participants in each category.

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This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy

Acronym: RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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