NCT01404520已完成不适用
Patient Activation, Counseling and Exercise - Acute Leukemia (PACE-AL) Health Promoting Rehabilitation. A Multimodal Exercise-based Intervention in Patients With Acute Leukaemia Undergoing Re-induction or Consolidation Chemotherapy
Universitetshospitalernes Center for Sygepleje4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Six Minute Walk Distance 6MWD
研究概览
简要总结
The purpose of this study is to test a new preventive and restorative intervention for patients with acute leukaemia undergoing consolidation chemotherapy, to measure and delineate the patients' treatment related symptom burden and to explore the effect of the intervention on length of hospital stay, duration of sick leave and return to work status. Further, to examine the relationship of the symptom profile with clinical indicators, physiological response, physical performance and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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 that are able to speak Danish > 18 years and newly diagnosed with acute leukæmia (MDS, AML, CMML, APL or ALL)
- •Normal EKG, blood pressure and pulse
- •Signed informed written consent
排除标准
- •Medical reason that contraindicates physical activity
- •Patients diagnosed with a symptomatic cardial disease
- •Documented bone metastasis
- •Cognitively or emotionally unstable
- •Unable to read or write in Danish
- •Patients unable to carry out baseline tests
结局指标
主要结局
Six Minute Walk Distance 6MWD
时间窗: Change from baseline in 6MWD at 12 weeks
Change in distance in meter
次要结局
- Estimated VO2 max Aastrand test(Change from baseline in VO2 Aastrand test at 12 weeks)
- Timed chair stand(Change from baseline in timed chair stand at 12 weeks)
- Timed biceps curl(Change from baseline in timed bicep curl at 12 weeks)
- EORTC QLQ-C30(Change from baseline in EORTC QLQ-C30 at 12 weeks)
- FACT-An(Change from baseline in FACT-An at 12 weeks)
- HADS(Change from baseline in HADS at 12 weeks)
- SF36(Change from baseline in SF36 at 12 weeks)
- MDASI(Change from baseline over time (1,2,3,4,5,6,7,8,9,10,11,12 weeks))
研究者
Mary Jarden
Research Fellow
Universitetshospitalernes Center for Sygepleje
研究点 (4)
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