Home-based Intermittent Pneumatic Compression Therapy: the Impact in Chronic Leg Lymphedema in Patients Treated for Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change of Inter-limb volume difference ratio
研究概览
简要总结
Investigators conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby gently facilitate lymphatic draining of proximal extremities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage 3 chronic unilateral secondary leg lymphedema
- •aged 20-70 years
- •underwent 1-2 cycle of treatment of decongestive phase with current inter-limb volume difference of more than 10%
- •stable limb-volume change (within 10%) during the preceding 3 months
- •capacity for self-maintenance care for lymphedema (multilayer limb bandaging, compression garments, and MLD)
排除标准
- •bilateral leg lymphedema
- •current cancer metastasis
- •ongoing chemotherapy or radiation therapy
- •acute inflammation
- •venous thrombosis, or chronic venous insufficiency
- •systemic etiologies of edema
- •congestive heart failure
- •patients taking medication that influenced body fluid or electrolytes
结局指标
主要结局
Change of Inter-limb volume difference ratio
时间窗: Baseline, after 1 month (4-week)
Investigators measured three leg volumes: the distal leg volume (distal volume: from the smallest circumference at the ankle (B-measure) to the calf circumference right below the knee bend (D-measure)), the whole leg volume (limb volume without the foot up to the mid-thigh region (F-measure)), and the proximal leg volume (subtraction of the distal leg volume from the whole leg volume)
次要结局
- Participant satisfaction questionnaire(after 1 month (4-week))
- Change of Quality of life (Lymph-ICF-LL)(Baseline, after 1 month (4-week))
研究者
JiHye Hwang
Professor
Samsung Medical Center