The Effect of Resistance Exercise in Patients With Lower Limb Lymphedema - With and With-out Compression - a Randomized Controlled Trial (the LymphEx Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Lower leg circumference
研究概览
简要总结
The aim of the study is to investigate the short-term (within 2 weeks) effects of resistance exercise with and without compression garments on lower limb lymphedema(LLL). Additionally, the study will explore the immediate response in LLL to resistance exercise (2 hours and 24 hours post-exercise).
Participants will continously wear a circumfencential sensor at the calf (CIMON from Icompression) under a compression garment and an activity tracker (SENS Motion from SENS Innovation Aps) at the thigh for 3 periods (two with supervised exercise sessions of 2 weeks and one control period).
Participants will attend supervised resistance exercise 2-3 times per week for 2 periods of 2 weeks (one with compression garment and one without). Assessments with the principal investigator will be scheduled before and after every 2 week period. Participants will keep a digital diary or diary in paper of their lymphedema related symptoms and experienced issues with the sensors or app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Statistician will be blinded for group allocation
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
- •verified diagnosis of lymphedema of the lower limb
- •completed compression bandaging
- •adherence to compression garment in daytime (minumum 5-6 days per week)
- •calf circumference > 35 and <75 cm
排除标准
- •severe neuropathy of the lower leg
- •severe skin problems or wounds at the lower leg
- •cellulitis, DVT or acute injuries of the lower limb < 2 months prior to inclusion
- •ongoing adjuvant treatment for cancer
研究组 & 干预措施
Group B
Week 1-2 exercise without compression, week 3 washout, week 4-5 exercise with compression, week 6 washout, week 7-8 no exercise
干预措施: Resistance exercise (Other)
Group A
Week 1-2 no exercise, week 3 washout, week 4-5 exercise without compression, week 6 washout, week 7-8 exercise with compression
干预措施: Resistance exercise (Other)
Group C
Week 1-2 exercise with compression, week 3 washout, weekend 4-5 no exercise, week 6 washout, week 7-8 exercise without compression
干预措施: Resistance exercise (Other)
结局指标
主要结局
Lower leg circumference
时间窗: 14 days
circumferential sensor CIMON, measured in Picoferens (pF)
次要结局
- Edema of the foot and ankle(14 days)
- Lower Limb volume(14 days)
- Extracellular fluid of the lower limb(14 days)
- Body composition(14 days)
- Segmental body composition of the lower limbs(14 days)
- Self reported lymphedema symptoms(14 days)
- Physical activity(14 days)
- Adverse events(14 days)
- Adherence to compression(14 days)
- Adherence to study(8 weeks)
- Withdrawal from study(8 weeks)
研究者
Carsten Bogh Juhl
Professor
Herlev and Gentofte Hospital