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临床试验/NCT04724356
NCT04724356已完成不适用

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

Qassim University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年1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
52
试验地点
2
主要终点
Health-related quality of life, Medical Outcomes Study short-form (SF-36)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age more than
  • 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.

排除标准

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

结局指标

主要结局

Health-related quality of life, Medical Outcomes Study short-form (SF-36)

时间窗: 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.

Limb volume measurement

时间窗: 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.

次要结局

  • Shoulder range of motion(after 12 weeks)
  • Visual analogue scale(after 12 weeks)
  • Muscle strength(after 12 weeks)

研究者

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

Maged Basha

Assistant Professor, Department of Physical Therapy, College of Medical Rehabilitation, Qassim University, Saudi Arabia, Qassim, Buraidah.

Qassim University

研究点 (2)

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