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

NCT07842237 | Active Not Recruiting FDA Device

• 1 other identifier: University of Damanhour, Egypt
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polyneuropathies; Regional Blood Flow; Lower Extremity

Keywords

lower limb perfusion; peripheral Neuropathy; Chemotherapy

Outcome Measures

Primary Outcomes (7)

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

• Change in active ankle dorsiflexion measured using a goniometer

  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.

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

• Change in passive ankle dorsiflexion measured using a goniometer

  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.

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

Secondary Outcomes (3)

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

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

• lower-limb pain intensity assessed using the Numeric Rating Scale

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

• lower-limb skin color assessed by standardized clinical inspection

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

Study Arms (2)

Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.

EXPERIMENTAL

Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.

Other: Exercises

Mechanical Compression Therapy

EXPERIMENTAL

Devise

Device: mechanical compression therapy

Interventions

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.

Mechanical Compression Therapy

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.

Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour University

Damanhūr, Damanhur, Egypt

Location

Related Publications (1)

• 1. Rao RD, Michalak JC. Chemotherapy-related toxicity in oncology practice. J Oncol Pract. 2018;14(2):89-96. 2. National Cancer Institute. Chemotherapy and you: support for people with cancer [Internet]. Bethesda (MD): National Institutes of Health; 2021 [cited 2026 Jun 18]. Available at: https://www.cancer.gov/ 3. Rahman N, Sukumar J, Maryam B. Chronic chemotherapy-induced peripheral neuropathy: living with neuropathy during and after cancer treatments. Ann Palliat Med. 2025;14(2). 4. Kruger-Genge A, Blocki A, Franke RP, Jung F. Vascular endothelial cell biology. Int J Mol Sci. 2019;20:4411. doi: 10.3390/ijms20184411 5. Starobova H, Vetter I. Pathophysiology of chemotherapy-induced peripheral neuropathy. Front Mol Neurosci. 2017;10:174. 6. Iorga RA, Bratu OG, Marcu RD, Constantin T, Mischianu DLD, Socea B, et al. Thromboembolism in cancer patients treated with chemotherapy-still a clinical concern. Cancers. 2019;18(6):5026-5032. doi: 10.3892/etm.2019.8019. 7. Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, et al. Long-term peripheral neuropathy in breast cancer patients treated with adjuvant chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018;110(2):djx162. 8. Zajączkowska R, Kocot-Kępska M, Leppert W, Wrzosek A, Mika J, Wordliczek J. Mechanisms of chemotherapy-induced peripheral neuropathy. Int J Mol Sci. 2019;20(6):1451. doi:10.3390/ijms20061451. 9. Gaballah A, Shafik A, Elhusseiny K, Ashraf M. Chemotherapy-induced peripheral neuropathy in Egyptian patients: single institution retrospective analysis. Asian Pac J Cancer Prev. 2018;19(8):2223-2227. doi: 10.22034/APJCP.2018.19.8.2223. 10. Health Promotion Administration, Ministry of Health and Welfare. Cancer Registry Annual Report 2020 [Internet]. 2020 [cited 2026 Jun 18]. Available at: https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=13498 11. Sarezky J, Sachs G, Elinzano H, Stavros K. Cancer and peripheral nerve disease. Clin Geriatr Med. 2021;37(2):289-300. 12. Sidhu D,

  BACKGROUND

MeSH Terms

Conditions

Polyneuropathies; Peripheral Nervous System Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical- Surgical Nursing , Faculty of Nursing, Damnhour University, Damnhour, Egypt

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: September 6, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)