Comparison of the 2MWT, the 10MeWT and the 6MWT in Individuals With Cancer, a Validation Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Primary endpoint: feasibility of the 2MWT and the 10MeWT
研究概览
简要总结
The aim of this study is to assess the feasibility and the validity of the 2-minute walk test (2MWT) and the 10-meter walk test (10MeWT) compared to the 6-minute walk test (6MWT) for subjects with onco-hematological disease.
详细描述
Cancer and its treatments have an impact on the body as a whole. The analysis of the subject's physical capacity is essential to know the basic level of the subject pre-treatment, to evaluate progress following rehabilitation, to set goals to prevent decline in physical capacity or to evaluate changes in physical capacity at different stages of survival. The 6-minute walk test (6MWT) is frequently used in the clinic to assess the physical capacity of the subject in oncology. A variant of the 6MWT exists and has been little studied in an oncological context: the 2-minute walk test (2MWT). The 2MWT is performed in the same way as the 6MWT: the same instructions and the same test procedure. It offers the advantage of being less tiring for the test subjects and saves clinicians time. The 2MWT has been validated in the past for people with COPD or after cardiac surgery. To our knowledge, it has not been validated for cancer patients.
The 10-meter walk test (10MeWT) is frequently used in practice to assess patients' functional capacity. It would be another way to assess the walking ability with a short test.
However, the relationship between the 2MWT, 6MWT and 10MeWT in an oncological context remain unclear.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Have an onco-hematologic disease
- •Have medical authorization from the patient's oncologist authorizing gait tests
- •Participate in the HUG rehabilitation program
- •Be able to give consent by signature
- •To be of legal age
- •Do not present pain when walking more than 2/10
- •Be able to walk with or without technical aids for a period of 6 minutes (as per patient's statement)
排除标准
- •Suffer from heart problems
- •Bone metastases at risk of fracture
- •Osteoporosis at high risk of fracture
- •Unbalanced Hypertension (hypertension)
- •Not being able to carry out the walk tests in their entirety
- •Not being able to perform the gait tests for reasons related to the side effects of the treatments (anemia, undernutrition, vomiting, severe fatigue, risk of thrombocytopenia, pain).
- •Not being able to carry out the walking test because of a lack of understanding of the instructions or because of psychological problems.
结局指标
主要结局
Primary endpoint: feasibility of the 2MWT and the 10MeWT
时间窗: through study completion, an average of 1 year
The feasibility of the different tests will be assessed in an oncological setting.
Primary endpoint: criterion validity with the 6MWT
时间窗: through study completion, an average of 1 year
Criterion validity will be assessed by calculating the strength of the correlation between the 2MWT/10MeWT and the 6MWT.
次要结局
- Secondary endpoint: convergent construct validity(through study completion, an average of 1 year)
- Secondary endpoint: criterion validity between 10m walk test and 10m walk test self-tested(through study completion, an average of 1 year)
研究者
Aline Reinmann
Principal Investigator
School of Health Sciences Geneva