Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in lower-limb circumference measured using a non-stretch measuring tape
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.
Buerger-Allen Exercise Arm: Participants will receive Buerger-Allen exercises.
干预措施: Exercises (Other)
Mechanical Compression Therapy
Devise
干预措施: mechanical compression therapy (Device)
结局指标
主要结局
Change in lower-limb circumference measured using a non-stretch measuring tape
时间窗: 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.
Change in lower-limb skin temperature assessment by palpation using the back of the fingers
时间窗: 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.
Change in lower-limb capillary refill time assessed by the blanching test
时间窗: 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.
Change in distal pedal pulse strength assessed using a standardized pulse-grading scale
时间窗: 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.
Change in lower-limb edema assessed using the pitting-edema grading scale
时间窗: 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.
Change in active ankle dorsiflexion measured using a goniometer
时间窗: 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.
Change in passive ankle dorsiflexion measured using a goniometer
时间窗: 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.
次要结局
- 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)
研究者
Azza Ibrahim Habiba
Professor of Medical- Surgical Nursing , Faculty of Nursing, Damnhour University, Damnhour, Egypt
Damanhour University