Effect of Lifestyle Intervention vs Physical Therapy Treatment in Patients With Secondary Lymphedema After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Lymphedema
研究概览
简要总结
Participants with lymphedema secondary to cancer treatment will participate in a two week rehabilitation programme focusing on physical therapy treatment and a two week programme focusing on physical exercise. The purpose is to assess the effect of the rehabilitation programmes on lymphedema and measures of physical performance.
详细描述
Traditionally, physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging is used for treatment of cancer treatment induced lymphedema. Alternatively, lifestyle interventions are used as treatment, with focus on physical exercise. However, the effects of such interventions are scarcely documented. Thus, the purpose of this study is to assess the effect of physical therapy treatment and physical exercise on lymphedema and measures of physical performance.
The study will be performed in a randomized cross-over design, encompassing 26 participants with secondary lymphedema related to cancer treatment. Firstly, half of the participants in the intervention group will be randomized to a two week rehabilitation programme focusing on physical activity while the other half to a rehabilitation programme focusing on physical therapy treatment, and the other way around three months later. In addition. there will be a control group with cancer related lymphedema not participating in any rehabilitation programme. Pre and post of each of the two week rehabilitation periods the following measurements will be performed: The magnitude of lymphedema by volume measurements of the limbs (by DXA); measurements of maximal strength, range of movement, flexibility, balance, physical functionality and questionnaires about perceived health and level of physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Secondary lymphedema in arm or/and leg related to cancer
排除标准
- 未提供
研究组 & 干预措施
Physical therapy treatment
干预措施: Physical therapy treatment (Other)
Lifestyle treatment
干预措施: Lifestyle treatment (Behavioral)
Control
Parallel control group, not undertaking any treatment and not part of the cross-over design
结局指标
主要结局
Lymphedema
时间窗: Change from before to the end of each of the two week rehabilitation programmes.
Ratio of the volume of affected limb vs volume of nonaffected limb measured by DXA
次要结局
- Self perceived health(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Flexibility in shoulder(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Test of physical functionality(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Maximal strength(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Balance(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Flexibility in hip and back(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Range of joint movement in the elbow, degrees of movement measured with a protractor(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Range of joint movement in the knee, degrees of movement measured with a protractor(Measured immediately before and at the end of each of the two week rehabilitation programmes.)
- Level of physical activity(Questionnaire will be completed immediately before the rehabilitation programmes, assessing the level of physical activity the prior three months.)