Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
试验速览
- 阶段
- 3 期
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
研究概览
简要总结
The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •More than 18 years of age
- •Patients who underwent pelvic lymphadenectomy
- •Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
- •The patient is able to understand the study and is willing to give written informed consent to the study
- •patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.
排除标准
- •Severe systemic diseases causing peripheral edema, including renal disease
- •Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
- •Acute superficial or deep vein thrombosis
- •Previous major surgery for lower extremities, including metallic surgical implant
- •Local infection in the lower extremities
- •Auto-immunological disorders or vasculitis
- •Use of systemic corticosteroids
- •Pregnant or currently breastfeeding
- •Alcohol or drug abuse
- •Uncontrolled diabetes
研究组 & 干预措施
Pelvic and lower extremity exercise
Experimental arm will be educated the guidelines for prevention and early detection of lower extremity edema. Additionally, pelvic and lower extremity exercise will be educated and participants will continue exercise for 1 year at home.
干预措施: Pelvic and lower extremity exercise (Other)
Control
Control group will be educated the guidelines for prevention and early detection of lower extremity edema
结局指标
主要结局
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
时间窗: 1 year after randomization
次要结局
- the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise(1 year after randomization)
研究者
Myong Cheol Lim
Senior researcher
National Cancer Center, Korea