High Intensity Interval Training (HIIT) on Stationary Bike With and Without Compression Stockings for Patients With Cancer-related Lymphedema in the Lower Limbs - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility rate
研究概览
简要总结
The aim of the study is to explore the feasibility and safety of High Intensity Interval Training on a stationary bike for patients with lymphedema in the lower limbs and the role of compression garments during exercise.
The design of the study is a cross-over randomized clinical trial. Participants will be randomized into two groups. Both will perform two separate exercise sessions.Group A will perform the first exercise with compression garment and the second session without compression garment, with wash-out period of 1 week between sessions. Group B will perform the exercise sessions in the opposite order.
详细描述
Lymphedema is a condition afflicting cancer patients who undergo surgery with removal of lymph nodes, chemotherapy and radiation. Lymphedema is a consequence of impaired lymphatic drainage in the interstitium, which causes edema and inflammation in the subcutaneous tissue. The symptoms are swelling, puffiness, tightness, heaviness and pain in the affected area.
Lymphedema can be reduced by complete decongestive therapy, which consists of skin care, manual lymphatic drainage, compression bandaging and exercise. At the end of treatment, patients are provided with custommade compression garments to be worn during daytime in order to maintain the reduction in the edema.
Lymphedema has a negative impact on activities of daily living and health-related quality of life. Patients with lymphedema should be encouraged to engage in physical activity despite their condition in order to prevent relapse of cancer and development of other diseases. Likewise physical activity helps to maintain a healthy weight, which is important as obesity has a negative impact on lymphedema. The lymphatic system is also stimulated by physical activity and exercise and can reduce the symptoms from the lymphedema.
Several studies have been published on the safety and benefits of exercise for women with breastcancer related lymphedema. However, only a few studies have investigated the feasibility of exercise to patients with lymphedema in the lower limbs. Also the role of compression garments during exercise have not been throughly explored.
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
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
- •unilateral or bilateral lymphedema in the lower limbs
- •secondary lymphedema
- •wears custommade compression stockings during daytime
- •lymphedema in stage 1, 2A or 2B (Classification from the International Society of Lymphology)
- •legally competent persons with ability to read and understand Danish.
排除标准
- •inability to perform the intervention, as assessed by the person performing inclusion.
- •lymphedema in stage 0 or 3 (Classification from the International Society of Lymphology)
- •ongoing complete decongestive lymphedema therapy
- •untreated erysipelas
- •ongoing oncologic treatment: chemotherapy, radiation, immune therapy,
- •known metastatic cancer
- •comorbidities e.g. deep venenous thrombosis, serious heart disease, renal insufficiency
研究组 & 干预措施
HIIT + compression
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session with compression garments/second without.
干预措施: First exercise session + compression (Other)
HIIT - compression
2 sessions of High Intensity Interval Training (HIIT) on a stationary bike. First exercise session without compression garments/second with
干预措施: First exercise session - compression (Other)
结局指标
主要结局
Feasibility rate
时间窗: After 3 months
Number of invited eligible participants enrolled in the study
Completion rate
时间窗: After 3 months
Number of enrolled participants completing both interventions
次要结局
- Change in tension related to lymphedema(Hour 0 and 1 post each exercise sessions)
- Change in weight of the lower limbs(Hour 0 and hour 1 post each exercise session)
- Change in pain related to lymphedema(Hour 0 and 1 post each exercise sessions)
- Change in volume of lower limbs(Hour 0 and hour 1 post each exercise sessions)
- Participant satisfaction(Week 2)
- Change in heaviness related to lymphedema(Hour 0 and 1 post each exercise sessions)
- Change in extracellular fluid in the lower limbs(Hour 0 and hour 1 post each exercise session)
研究者
Merete Celano Wittenkamp
Pricipal Investigator
Herlev and Gentofte Hospital