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临床试验/NCT03945838
NCT03945838已完成不适用

Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

Ege University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
1
主要终点
Hand grip strength

研究概览

简要总结

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having had mastectomy or breast conserving surgery
  • Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

排除标准

  • The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded

结局指标

主要结局

Hand grip strength

时间窗: 3 weeks

Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.

Extremity volume

时间窗: 3 weeks

Volume measurements were taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm was calculated and recorded before and after the treatment for both arms. All patients' measurements were taken by the same researcher.

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

Göksel Tanıgör M.D.

Researcher in Ege University School of Medicine

Ege University

研究点 (1)

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