The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Lower limb muscle strength change from baseline to 3 months
研究概览
简要总结
Background:
The incidence of lower limb lymphedema (LLL) after gynecological cancer surgery with lymphadenectomy is about 10-46%. Lower limb lymphedema results in limited physical mobility and reduced patients' quality of life. A hospital -based complete decongestive therapy has been recommended to patients with LLL, including exercise, manual lymphatic drainage, compression therapy, and skin care. However, the inconvenience of the hospital-based rehabilitation program limit the availability for those patients LLL. Home-based exercise program may be feasible instead of the hospital-based program. Few studies have evaluated the effectiveness of the home-based lower extremity exercise on reliving LLL and improving quality of life in patients with LLL.
Research Purposes:
The main purpose of the study is to evaluate the effectiveness of a home-based exercise program for relieving lower extremity lymphedema, including circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, quality of life related to cancer & LLL, and fatigue.
Methods:
This study is a two- year project with a single-blind randomized clinical trial. The participants are women with gynecological cancer surgery, aged of 20-75 years and currently have lower extremity lymphedema. A sample of 76 participants will be stratified randomly assigned to an experimental group or a control group. The experimental group is to carry out a home-based anti-resistance exercise with elastic band other than a routine care of complex decongestive physiotherapy; while the control group is to carry out a routine care of complex decongestive physiotherapy. The home-based program is a 12-week exercise program. Data collections will be conducted before exercise (Baseline), during exercise (second months), and exercise program after completion. Measures includes (1) Physical examination: limb leg circumference measurement, bioimpedance spectroscopy (BIS), lower limb muscle strength, (2) Questionnaires: Functional status of lymphatic edema of LLL, fatigue, and EORTC-QLQ-C30.
Anticipated Outcomes:
Findings from this study could provide a reference of home-based exercise guideline and be integrated into the care of activities for women following gynecological surgery with LLL.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with gynecological cancer surgery
- •aged of 20-75 years
- •currently have lower extremity lymphedema.
排除标准
- •heart failure
- •kidney failure
- •limb surgery
结局指标
主要结局
Lower limb muscle strength change from baseline to 3 months
时间窗: from baseline to 3 months
Measuring by microFET 2
Edema change from baseline to 3 months
时间窗: from baseline to 3 months
Measuring by Bioelectrical Impedance Spectroscopy (BIS)- InBody S10
Limb circumference change from baseline to 3 months
时间窗: from baseline to 3 months
Measuring by measuring tape
Fatigue change from baseline to 3 months
时间窗: from baseline to 3 months
Measuring by Chinese Lee Fatigue Scale Short Form (C-LESSF). It is a 7-item, from 0(no fatigue) to 10(very fatigue) questionnaire.
EORTC-QLQ-C30
时间窗: from baseline to 3 months
Measuring by EORTC QLQ C30. It is a 30-item, from 0(no problem) to 10(very severe) questionnaire.
Functional status of lymphatic edema of LLL change from baseline to 3 months
时间窗: from baseline to 3 months
Measuring by Lymphoedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphoedema (Lymph-ICF-LL). It is a 28-item, 0(no problem) to 10(very severe) questionnaire.
次要结局
未报告次要终点
研究者
Yu-Yun Hsu
Professor
National Cheng Kung University
