Efficacy of Aquatic Physiotherapy in the Treatment of Upper Limb Lymphedema in Women With Breast Cancer: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Volume of the affected limb.
研究概览
简要总结
This study aims to evaluate the effectiveness of Aquatic Therapeutic Exercise by providing a set of exercises in the reduction and / or control the volume of secondary lymphedema treatment of breast cancer in patients who are in the maintenance phase of conventional treatment. It is an experimental, randomized, unifactorial, and intersubjective study. The intervention group will be treated by guided underwater exercises while the control group will receive the same set of exercises out-of-water. The research will be based on comparing the difference on the volume of lymphedema obtained by the exercises provided aquatic environment and out-of-water exercises. The study population will be obtained from rehabilitation service Bellvitge Hospital. The goal is to evaluate the volume of lymphedema and the quality of life related to the health of patients will be evaluated before starting the treatment, at the end of the 20 sessions, when the treatment reaches 3 months and when patient is discharged.
详细描述
A randomized controlled experimental study has been carried out where two work groups were compared, experimental N: 43 that carried out an exercise regimen designed in the aquatic environment and control N: 47 that carried out the same regimen of exercises in a physiotherapy room. Both groups did 20 treatment sessions of 45 minutes duration with a frequency of 2 or 3 days per week. Lymphedema changes, quality of life and adherence to treatment were evaluated. The evaluations were 3 days prior to the start of the program, at the end of the 20 sessions, and at 3 months.
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 (Investigator)
盲法说明
The initial, intermediate and final evaluations were carried out by a blind researcher, not familiar with the group assigned to the patients.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female gender.
- •Age between 18 and 75 years.
- •Diagnosis of lymphedema in the upper limb secondary to breast cancer treatment.
- •Present mild lymphedema or moderate (types I and II respectively according to the volumetric classification of the types of edema according to severity).
排除标准
- •Primary lymphedema or secondary to other surgery.
- •Bilateral lymphedema.
- •Presence of hydrophobia.
- •Severe cardiovascular and respiratory diseases.
- •Urinary and fecal incontinence.
结局指标
主要结局
Volume of the affected limb.
时间窗: 3 days before the start of the program, at 30 days, and at 3 months after completing the sessions.
The investigators assessed changes in the volume of the affected limb over a specified period of time and possible long-term improvements. The independent variable studied was the effect of exercise in water compared with exercise out of water. The expected outcome (dependent variable) was a reduction or maintenance of the volume of the lymphedema-affected limb. A measuring tape was used to take serial circumferential measurements of both limbs using anatomical reference points on both sides.
次要结局
- Age.(3 days before the start of the program.)
- Severity of lymphedema(3 days before the start of the program, at 30 days and at 3 months after completing the sessions.)
- Quality of life health related.(3 days before the start of the program, at 30 days and at 3 months after completing the sessions.)
- Adherence(At 3 months after completing the sessions.)
研究者
Isabel Lopez Zamora
Physiotherapist
Hospital Universitari de Bellvitge