跳至主要内容
临床试验/NCT01581346
NCT01581346
已完成
2 期

Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer

German Cancer Research Center1 个研究点 分布在 1 个国家目标入组 40 人2011年3月

概览

阶段
2 期
干预措施
未指定
疾病 / 适应症
Non Small Cell Lung Cancer
发起方
German Cancer Research Center
入组人数
40
试验地点
1
主要终点
- number of patients who are adherent to the exercise intervention
状态
已完成
最后更新
14年前

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).

注册库
clinicaltrials.gov
开始日期
2011年3月
结束日期
2011年12月
最后更新
14年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

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)

研究点 (1)

Loading locations...

相似试验