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Effect of Exercise Mode in Breast Cancer-Related Lymphedema (Lymphedema)

2021年9月8日 更新者：Maged Basha、Qassim University

Effect of Exercise Mode on Physical Function and Quality of Life in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial

Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema. Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment. This study compared the effect of Xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life. Women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group KBRG and resistance exercise group REG. woman in The KBRG received virtual reality therapy using Xbox Kinect-based games, the REG received resistance training in addition both groups received complex decongestive physiotherapy. The intervention was five sessions per week for 8 weeks. The outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life. All these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (W8).

研究类型

介入性

注册 (实际的)

52

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 埃及
      • Cairo、埃及、11241
        • Shorook Physical Therapy Centers

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Age more than 30.
  • Histological diagnosis of breast cancer at least 1 year prior to the study.
  • Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
  • Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.

Exclusion Criteria:

  • Unstable lymphedema, receiving intensive therapy within the previous 3 months.
  • A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Virtual Reality Group
The Kinect based rehabilitation group received virtual reality therapy using Xbox Kinect-based games, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
其他：Virtual Reality
Intervention was led once per day, five days a week, over 8 weeks.
其他名称：
  • complex decongestive physiotherapy
实验性的：Resistance exercise Group
The resistance exercise group received resistance training, in addition to complex decongestive physiotherapy. The intervention was led once per day, five days a week, over 8 weeks. All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
其他：Resistance Exercise
Intervention was led once per day, five days a week, over 8 weeks.
其他名称：
  • complex decongestive physiotherapy

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Limb volume measurement
大体时间：at baseline
assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
at baseline
Limb volume measurement
大体时间：after 8 weeks
assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
after 8 weeks
Limb volume measurement
大体时间：after 12 weeks
assessed by circumference measurements using a non-elastic tape. Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
after 12 weeks
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
大体时间：at baseline
assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
at baseline
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
大体时间：after 8 weeks
assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
after 8 weeks
Health-related quality of life, Medical Outcomes Study short-form (SF-36)
大体时间：after 12 weeks
assessed using the Medical Outcomes Study short-form (SF-36). Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
after 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Shoulder range of motion
大体时间：at baseline
Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
at baseline
Shoulder range of motion
大体时间：after 8 weeks
Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
after 8 weeks
Shoulder range of motion
大体时间：after 12 weeks
Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position. External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
after 12 weeks
Visual analogue scale
大体时间：at baseline
used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
at baseline
Visual analogue scale
大体时间：after 8 weeks
used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
after 8 weeks
Visual analogue scale
大体时间：after 12 weeks
used to quantify the severity of perceived pain, heaviness, and tightness. Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
after 12 weeks
Muscle strength
大体时间：at baseline
The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
at baseline
Muscle strength
大体时间：after 8 weeks
The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
after 8 weeks
Muscle strength
大体时间：after 12 weeks
The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
after 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Qassim University

合作者

Cairo University

调查人员

  • 首席研究员：Maged Basha, PhD、College of medical rehabilitation, Qassim University
  • 研究主任：Fatma Alzahraa Kamel, PhD、Cairo University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年1月15日

初级完成 (实际的)

2020年4月20日

研究完成 (实际的)

2020年5月5日

研究注册日期

首次提交

2021年1月21日

首先提交符合 QC 标准的

2021年1月21日

首次发布 (实际的)

2021年1月26日

研究记录更新

最后更新发布 (实际的)

2021年9月16日

上次提交的符合 QC 标准的更新

2021年9月8日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2449PT

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

IPD 共享时间框架

6 months after publication

IPD 共享访问标准

relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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