Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
研究概览
简要总结
In 20 years, the prognosis of hematology patients has improved thanks to the development and adaptation of treatments and better risk management. However, medium and long-term complications of intensive treatments are common and remain a real public health problem. Indeed, intensive treatments associated with room confinement within a protected unit expose patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this deconditioning is neglected, response to treatment, tolerance, quality of life and, in the longer term, survival will be impacted.
Several teams have demonstrated the feasibility and the benefits of physical support for patients with prolonged aplasia. These studies focused on peripheral stem cell allograft, which occur late in the treatment of acute leukemia. On the other hand, studies evaluating the benefits of physical support as soon as the diagnosis of acute leukemia is made and intensive treatments are started are rare. Implementing a adapted sport program from the diagnostic and throughout the course of treatment is therefore a worthwhile subject for research.
The adapted sport chosen was fencing because it responds to hematological problems. Fencing is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair or in bed, involves praxis and concentration, and involves the whole body. It can be practiced individually or as part of a team, in a protected room or in a unit corridor. Fencing is a fighting sport and includes a psychological aspect, with a possible projection of a fight against the disease. In addition, fencing is carried out by a non-medical or paramedical practitioner, which can reinforce or recreate an image of normal activity. Finally, the attention required by listening to the fencing master and the necessary concentration unconsciously pushes the patient to "get out of his illness".
The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an adapted sport program based on fencing in adult patients with hematological malignancies receiving intensive treatment, to reduce physical deconditioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patient admitted to a protected unit of the Hematology department of one of the participating centers
- •Patient with acute leukemia treated in induction with "3+7" or "5+7" intensive treatment or by an equivalent treatment (Vyxeos, azacitidine+vénetoclax), or patient admitted for an allograft or CAR-T cells and not included at the diagnosis of the disease
- •Patient eligible for intensive chemotherapy
- •Patient requiring prolonged hospitalization with room confinement
- •Signed informed consent form
排除标准
- •Patient with a neurological or cardiac disease that contraindicates the practice of fencing
- •No intensive treatment with prolonged hospitalization
- •Pregnant, parturient or breastfeeding woman
- •Person deprived of liberty by judicial or administrative decision
- •Person under forced psychiatric care
- •Person under legal protection
- •Person unable to express consent
- •Person not covered by or not benefiting from a social security system
研究组 & 干预措施
Patients benefiting from the adapted sport program based on fencing
干预措施: Adapted sport program based on fencing (Other)
结局指标
主要结局
Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
时间窗: 1 year
The proportion of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program will be used to evaluate the feasibility of the adapted sport program based on fencing.
次要结局
- Comparison between the EORTC-QLQC30 score obtained at inclusion and the score obtained at each prolonged hospitalization discharge and at 3 months, 6 months and 1(1 year)
- Average duration of fencing lessons(1 year)
- Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up(6 months)
- Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program(1 year)
- Number of actual fencing lessons compared to number of scheduled fencing lessons(1 year)
- Average duration of the program(1 year)
- Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up(6 months)
- Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up(6 months)