Prevention-Related Lymphatic Response to Resistance Exercise in Breast Cancer Survivors at Risk of Breast Cancer-Related Lymphedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Changes in volume difference between extremities (%)
研究概览
简要总结
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.
详细描述
Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).
To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.
Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of the researchers in charge of the evaluations and data analysis will be implemented, so that they are unaware of the assignment of each patient to the groups. It is not possible to blind participants and the physiotherapist (care provider) due to the very nature of the intervention
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
- •Women diagnosed with breast cancer
- •Being of legal age
- •Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year
- •Unilateral involvement
- •Surgery for the tumor at least 6 weeks before the start of the intervention
- •WHO performance status of 0 (asymptomatic, complete and ambulatory activity)
- •Correct understanding of Spanish
- •Approval by signing the informed consent;
- •Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI >30 kg/m
- •. These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves
排除标准
- •Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio > 10 or a difference in volume equal to or greater than 10% between both extremities
- •Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema;
- •Suffer from conditions that prevent resistance exercise of the upper body
- •Participation in regular (>1 time/week) and intense exercises involving the upper extremity during the last month
- •Suffer from heart disease
- •Inability to complete questionnaires;
- •A physical condition that prevents them from making hospital visits
- •Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids
- •Women which presents some type of wound or infection on the skin.
结局指标
主要结局
Changes in volume difference between extremities (%)
时间窗: Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
The volume of both extremities will be measured to obtain the difference between both, which will be used as a relative criterion to determine the preventive effect of the intervention, determining the appearance of LACM as those cases in which the patient reaches a difference after one year of follow-up. volume equal to or greater than 10% between both extremities. It will be measured using water displacement volumetry, considered the gold standard for measuring the volume of the affected limb.
次要结局
- Changes in extracelular fluid (ECF)(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Perceived shoulder function (%)(Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up))
- Changes in echogenicity of the dermis and subdermis(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Changes in Percentage Water Content (PWC)(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Changes in elastic properties of tissues.(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Changes in Thickness of the dermis and subdermis(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Quality of life (QoL)(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Grip strength (kg)(Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up))
- Fear-Avoidance(Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up))
- Active Range of Movement (AROM, degrees)(Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year)
- Symptoms Related to Lymphedema(Three measures: Baseline , after 3 month once completed the whole intervention (post-intervention) and after 1 year (follow-up))
研究者
Cristina Roldán-Jiménez
Profesor and Reseacher (PT, PhD)
University of Malaga