Treatment Adherence to a Personalized Home Exercise Program in Patients With Bone Cancer Undergoing Lower Extremity Resection and Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- adherence to the rehabilitation program
研究概览
简要总结
The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.
详细描述
In cancer patients undergoing adjuvant therapies, rehabilitation plays an important role in reducing the side effects of chemotherapy treatment by promoting cardiorespiratory function, reducing fatigue and improving quality of life. Physiotherapy treatment, generally, includes physical training programs administered in many ways, not yet well standardized. With the aim of seeking an empowerment of the patient and his active participation, more and more exercise programs are used that the patient is able to manage independently. Adherence to and compliance with such exercise programs is extremely variable in literature and can range from 52% to 89%. A high level of adhesion is a well-known challenge and a fundamental prerequisite for achieving the benefits of physical activity. Home exercise programs to be performed in complete autonomy have been proposed in patients with different types of cancer, while for patients with bone tumor, to date there are no experiences. In this group of patients the role of physiotherapy is significant not only to counteract the adverse effects of chemotherapy treatment but also to promote the recovery of patients following the important resection and reconstruction interventions. In this type of patient, a high adherence to the physiotherapy treatment started already during the periods of hospitalization for the administration of antiblastic treatment.
Data will be collected from all patients treated consecutively over two years according to the defined inclusion criteria. Given the rarity of oncologic pathology of the musculoskeletal system and the limited number of patients of 27 found to meet the inclusion criteria in the year 2021, it is assumed that data will be collected from a sample of 50 patients.
The variables collected will be: age, sex, BMI, smoking, physical activity level, diagnosis, metastasis at diagnosis, type of surgery, chemotherapy treatment.
Data will be described by mean and standard deviation or median and interquartile range values according to the nature of the data and frequency and percentage for dichotomous variables
The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 12 years with bone tumor undergoing surgery (resection and reconstruction of the lower limb) and in adjuvant treatment
- •patients under physiotherapy treatment
排除标准
- •patients with difficulties in understanding the Italian language
- •patients not using digital services
结局指标
主要结局
adherence to the rehabilitation program
时间窗: everyday from baseline at 6 months
every day the patient will record the exercise execution/not-execution
次要结局
- patient satisfaction(at 3 months and at 6 months)
- TESS(at 3 months and at 6 months)
- TUG(at 3 months and at 6 months)
