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临床试验/NCT05003973
NCT05003973Unknown不适用

The Effectiveness of Anti-resistance Exercise on Lower Limb Lymphoedema Among Gynecological Cancer

National Cheng Kung University0 个研究点目标入组 100 人开始时间: 2021年8月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-Yun Hsu

Professor

National Cheng Kung University

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