Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- - number of patients who are adherent to the exercise intervention
研究概览
简要总结
In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.
详细描述
In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male and female patients
- •histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
- •current treatment: chemo-and/or radiotherapy
- •age > 18y
- •Body Mass Index (BMI) > 18
- •written informed consent
排除标准
- •acute infection
- •immobility > 2 days
- •severe neurological impairment
- •severe cardiac impairment
- •severe pulmonal impairment
- •severe renal impairment
- •acute bleedings
- •alcohol-/drug-abuse
结局指标
主要结局
- number of patients who are adherent to the exercise intervention
时间窗: 8 months
Adherence is defined as: completion of at least two training sessions per week during minimum six weeks out of eight weeks of the intervention.
次要结局
- - effects of the exercise intervention on psychological symptoms (e.g. quality of life)(8 months)
- - effects of the exercise intervention on physical symptoms (muscle strength and endurance)(8 months)