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临床试验/NCT06200948
NCT06200948已完成不适用

Effects of Aerobic Cycling Training in Patients With Gynecologic Cancer-related Lower Extremity Lymphedema: A Randomized Comparative Study

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 63 人开始时间: 2023年10月15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
63
试验地点
2
主要终点
Effect of Aerobic Training

研究概览

简要总结

Comparison of complete decongestive treatment and complete decongestive treatment + cycling ergometry treatment in patients with gynecologic cancer-related lower extremity lymphedema in terms of quality of life, lower extremity functionality and lower extremity volume measurement

详细描述

After being informed about study and potential risks, all patients giving written informed consent will undergo screening period determine eligibility for study entry. The patients who met the eligibility recruitments will get into the assessment.

The study will include 63 participants (31 controls and 32 interventions). Simple randomization will be preferred in this study. The coin toss method will be used for simple randomization.

Researcher will record demographic and clinical data of the patients and will evaluate the patients' pre-treatment volumes by circumference measurement method. Researcher will evaluate quality of life by lymphedema quality of life questionnaire (LYMQOL) and lower extremity functionality by lower extremity functional scale (LEFS). While the patients in non-cycling group will get only complete decongestive treatment (CDT) for 3 weeks, the patients in cycling group will get CDT+cycling ergometry treatment for 3 weeks.Cycling ergometry treatment will be performed with Voit AT-200 Black Collection horizontal bike for 20 minutes. Exercise intensity will be adjusted to %40-59 of heart rate reserve (HRR). At the end of treatment; Researcher will evaluate volume, functionality and quality of life of the patients again and will compare the two groups in terms of volume measurement, functionality and quality of life.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being cognitively competent
  • Chemotherapy radiotherapy etc. treatment has been completed and there is no oncological risk
  • Signing written informed consent to participate in the study

排除标准

  • Cardiac failure
  • Uncontrolled hypertension
  • Having kidney failure
  • Having a systemic infection
  • Local infection such as erysipelas and cellulitis in the lower extremities
  • Venous insufficiency (DVT etc.)
  • Presence of any neuromuscular disease affecting the lower extremities
  • Having lipolymphedema
  • Fracture in the lower extremity
  • Having active metastasis
  • Having a language problem
  • Being pregnant
  • Being unable to continue treatment

结局指标

主要结局

Effect of Aerobic Training

时间窗: baseline and at 3rd weeks

Assesment of the effect of aerobic training on quality of life, functionality and volume difference in patients with gynecologic cancer-related lower extremity lymphedema

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

Onur Kara

Medical Doctor (Physical Medicine and Rehabilitation Resident Doctor)

Ankara City Hospital Bilkent

研究点 (2)

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