Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Lymphedema Arm Volume
研究概览
简要总结
The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is a female with a history of breast cancer;
- •Has undergone surgery, including sentinel lymph node biopsy or axillary lymph node dissection;
- •Has visible and palpable unilateral mild to moderate BCRL of at least 200 ml inter-limb volume difference (full limb) or regional lymphedema: defined as a minimal volume difference of 100 ml or 5% in a segment of the arm (e.g. hand and forearm region, elbow and upper arm) after correcting for arm dominance;
- •Has chronic lymphedema, defined as lymphedema that has been present for at least 3 months;
- •Is in the lymphedema maintenance phase of conservative treatment;
- •Uses a well fitted compression sleeve (not older than 1 month) and is agreeable to wear the sleeve for a minimum of 12 hours per day (providing a minimum of 30 mm Hg of pressure);
- •Is agreeable to discontinuing other lymphedema treatments that are beyond standard care, including manual lymph drainage and intermittent pneumatic compression during the 12-week RCT period of the study.
- •Is able to read and understand English.
排除标准
- •Are undergoing or are scheduled to receive chemotherapy or radiotherapy
- •Presents with limb infection/ cellulitis, deep vein thrombosis, or have active metastatic disease;
- •Has any neurological or cognitive deficit, is pregnant, uses a pacemaker, or has other uncontrolled health condition that may interfere with assessment and/or the progressive resistance exercise training intervention;
- •Has any contraindications related to wearing compression on the limb, including arterial insufficiency or congestive heart failure;
结局指标
主要结局
Change in Lymphedema Arm Volume
时间窗: Up to 24 weeks
Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).
次要结局
- Change in Grip Strength(Up to 24 weeks)
- Change in Extracellular Fluid Volume(Up to 24 weeks)
- Change in Muscle Strength(Up to 24 weeks)
- Health-Related Quality of Life (Lymph-ICF)(Up to 24 weeks)
- Exercise and Compression Adherence(Up to 24 weeks)
- Health-Related Quality of Life (SF-36)(Up to 24 weeks)
- Physical Activity Level(Up to 24 weeks)
- Change in Shoulder Range of Motion(Up to 24 weeks)