Clinical and Functional Variables in the Assessment of Oncology Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Cancer-Related Fatigue (CRF)
研究概览
简要总结
The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several clinical and functional outcomes in cancer patient and survivors
详细描述
In the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. Given the risk of obesity, both exercise and diet play a key role in recovery from cancer.
Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education programme (TEEP) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors.
Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the case of survivors: Patient who had been surgically treated for their primary tumour with no evidence of recurrence at the time of recruitment. The inclusion of patients undergoing hormonal treatment radiotherapy or antiHER therapy will be allowed.
- •In the case of cancer patients: patient who had been dignosed by cancer.
- •In both cases, all participants have to maintain the minimum physical function to perform exercise in group.
排除标准
- •Patients were excluded if they had suffered any cardiovascular event defined as stable or unstable angor, acute pulmonary edema, cardiac rhythm disorders, or syncope of cause not affiliated in the year prior to inclusion
结局指标
主要结局
Change from Cancer-Related Fatigue (CRF)
时间窗: Prior and after intervention, an average of 3 months
The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used
Change from Upper limb functionality (%)
时间窗: prior and after intervention, an average of 3 months
the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled
Change from Lower limb functionality(%)
时间窗: prior and after intervention, an average of 3 months
the Spanish version of the Lower Limb Functional Index (LLFI) questionnaire will be filled
Change from Functional capacity
时间窗: prior and after intervention, an average of 3 months
It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
次要结局
- Body Composition(prior and after intervention, an average of 3 months)
- Change fromQuality of life (self-reported questionnaire)(prior and after intervention, an average of 3 months)
- Change from specific Breast Cancer Quality of life (self-reported questionnaire)(prior and after intervention, an average of 3 months)
- Change from Grip Strength (dynamometry)(prior and after intervention, an average of 3 months)
- Change from fat mass(prior and after intervention, an average of 3 months)
- Change from lean mass(prior and after intervention, an average of 3 months)
- Change from water balance(prior and after intervention, an average of 3 months)
- Change from Muscle thickness(prior and after intervention, an average of 3 months)
- Change from Basal Metabolism(prior and after intervention, an average of 3 months)
- Change from Body Mass Index(prior and after intervention, an average of 3 months)
- Change from Physical activity (METS)(prior and after intervention, an average of 3 months)
- Change from Handgrip Strength (Kg)(prior and after intervention, an average of 3 months)
研究者
Dr. Antonio I Cuesta-Vargas
Principal Researcher of CTS631 University of Malaga
University of Malaga