Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- Cardiorespiratory fitness (CRF)
研究概览
简要总结
In people diagnosed with lymphoma receiving immunochemotherapy treatment, a combined exercise intervention, as opposed to the general recommendations, will achieve: 1.Improve cardiorespiratory fitness, strength, psychological well-being and quality of life. //2.Reduce fatigue//3.Reduce frailty
There is an association between some biological biomarkers with physical capacity and frailty.
详细描述
In this study, the effectiveness of an individualized adjuvant exercise program will be analyzed in a homogeneous population of people diagnosed with lymphoma in active treatment. Taking into account the limited scientific evidence that currently exists in people affected by lymphoma and active treatment, the study could be of great relevance when it comes to providing scientific evidence in this very little field studied. The study will try to respond to the evident need to focus the research area on supervised exercise in people with lymphoma in a way innovative, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction of this type of interventions into the health system. The present study will also analyze the effect of exercise from a gender perspective, an aspect not systematically studied until now, providing a new vision on the baseline differences and after intervention of a program based on of sex.
The study will include adults with lymphoma with special focus on the subanalysis of the group of patients equal or more than 70 years old. The lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new exercise project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic. 30 people with lymphoma and treatment have been included in the Onkofrail study asset. The preliminary results of said pilot study have been used for the design of this new study, making adaptations, both in the recruitment time, as well as inclusion and exclusion criteria, which guarantee and optimize the correct research development.
Main objective:
The main objective is to assess whether a supervised (2 days/week) combined (resistance+aerobic interval training) exercise intervention, plus 2 days/week unsupervised for 20 weeks improves cardiorespiratory fitness (CRF) in people diagnosed with lymphoma undergoing chemotherapy, compared to a control group receiving only general recommendations.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age: ≥18 years old.
- •Diagnosis of lymphoma with histological confirmation and requirement of systemic treatment including chemotherapy.
- •Time available (80 minutes, two days a week for 20 weeks) to carry out physical exercise sessions.
- •Have a mobile phone to be able to contact the person and download the physical activity level app.
- •Eastern Cooperative Oncology Group performance status (ECOG) ≤
- •Life expectancy >12 months.
- •Availability and desire to participate throughout the study period.
排除标准
- •Have a contraindication to moderate-high intensity exercise.
- •Other significant medical disorders: including psychiatric illnesses chronic or recurrent; intellectual disability, musculoskeletal problems, cardiac or pulmonary disorders that interfere with physical exercise; other malignant tumors in the last five years, with the exception of therapeutically controlled skin cancer; any other illness that may be seen affected or aggravated by physical exercise.
- •Have plans to be outside city more than two weeks.
- •People who are already physically active (that comply with the recommendations of WHO: > 150 minutes of exercise moderate/weekly, plus training force two days/week).
- •Treatment based only with immunotherapy.
- •Central nervous system involvement due to lymphoma.
- •Have any important history that limit the capacity of the patient to participate in the study.
结局指标
主要结局
Cardiorespiratory fitness (CRF)
时间窗: 20 weeks
Measured by peak oxygen uptake (VO2peak) before starting chemotherapy treatment and after 20 weeks of intervention, using the cardiorespiratory exercise test.
次要结局
- Sociodemographic, etiological and clinical health variables (B)(20 weeks)
- Sociodemographic, etiological and clinical health variables (C)(20 weeks)
- Sociodemographic, etiological and clinical health variables (D)(20 weeks)
- Sociodemographic, etiological and clinical health variables (A)(20 weeks)
- Sociodemographic, etiological and clinical health variables (E)(20 weeks)
- Sociodemographic, etiological and clinical health variables (F)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (A.1.)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (A.2.)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (B.1.)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (B.2.)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (C)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (D)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (E)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (F)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (G)(20 weeks)
- Functionality and fragility variables at times T0, T1 and T2 (H)(20 weeks)
- Patient Reported Results (A)(20 weeks)
- 3. Patient-reported results (PRO):(20 weeks)
- Biomarkers(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (A)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (B)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (C)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (D)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (E)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (F)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (G)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (H)(20 weeks)
- Variables of Geriatric Assessment (VGA) comprehensive in patients (I)(20 weeks)
- Treatment data and results after the intervention (T2) (A)(20 weeks)
- Treatment data and results after the intervention (T2) (B)(20 weeks)
- Treatment data and results after the intervention (T2) (C)(20 weeks)
- Treatment data and results after the intervention (T2) (D)(20 weeks)
- Assessment of the intervention at T2 (A)(20 weeks)
- Assessment of the intervention at T2 (B)(20 weeks)
- Assessment of the intervention at T2 (C)(20 weeks)