Investigation of Fall Risk Factors and Implementation of an Exercise Intervention for Prevention of Falls in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effectivity (fear of falling)
研究概览
简要总结
Approximatly one third of the population over the age of 65 fall at least once a year. The risk of falling is in increased in older patients with tumor diseases. In addition to high treatment and care costs for the healthcare system, falls often lead to a decrease of quality of life, a reduction in physical performance and a loss of independence. Despite the high risk, falls in cancer patients have not yet been scientifically investigated in detail. For patients with multiple myeloma in particular, very little data is available on the prevalence, risk factors and effects of falls. In this study, a fall risk assessment is carried out in patients with multiple myeloma. Furthermore, a patient-specific training intervention for fall prevention will be carried out.
The aim of the study is to identify possible fall risk factors in multiple myeloma patients and to establish a structured exercise intervention that minimizes the risk of falls and injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients with multiple myeloma requiring therapy (at least 6 months of systemic therapy)
- •ECOG status ≤ 3
- •Age ≥18 years
- •Patients who state that they want to carry out the training program at least 3 times/week and participate in the planned follow-up visits
- •Ability to give informed consent
- •Written consent to participate in the study
- •Sufficient written and spoken German to complete the questionnaire
排除标准
- •Any physical or mental limitations that would prevent participation in the training program or the planned follow-up checks.
研究组 & 干预措施
Exercise Intervention
Fall Prevention
干预措施: Strength and balance training in combination with a treadmill-based pertubation intervention (Other)
结局指标
主要结局
Effectivity (fear of falling)
时间窗: Evaluated at the beginning of the study and at the end of the study after 6 months
Fear of falling will be evaluated by a validated questionnaire (FES-I, Falls Efficacy Scale-Inernational). The questionnaire contains 16 items scored on a four-point scale (1=not at all concerned to 4=very concerned). Scores \>23 indicate high concern about falling.
Feasibility of at least 48 out of 72 training sessions with the focus on fall prevention within 24 weeks
时间窗: From enrollement to the end of the training intervention at 6 months
Patients will document the number of training sessions via an online training-app (Physiotec, Bad Wünnenberg, Germany). Feasibility is achieved if 48 of 72 possible training sessions were successfully completed.
次要结局
未报告次要终点
研究者
Ulrike Dapunt
Prof. Dr. med.
University Hospital Heidelberg