NCT01557686已完成早期 1 期
Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial
Universitetshospitalernes Center for Sygepleje2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility - adherence rates
研究概览
简要总结
The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 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 cardiac disease within the last three months.
- •Documented bone metastasis
- •Dementia, psychotic
- •Cannot write or read Danish
- •Patients unable to carry out baseline tests
结局指标
主要结局
Feasibility - adherence rates
时间窗: Adherence to the intervention components from baseline to 6 weeks
Percentage of intervention participation
次要结局
- Adverse events(baseline to 6 weeks)
- 6MWD(Change from baseline in 6MWD at 6 weeks)
- Attrition(Withdrawal from the project from baseline to 6 weeks)
- Timed chair stand(Change from baseline in timed chair stand at 6 weeks)
- Timed bicep curl(Change from baseline in timed bicep curl at 6 weeks)
- FACT-Anemia(Change from baseline in FACT-An at 6 weeks)
- HADS(Change from baseline in HADS at 6 weeks)
- SF36(Change from baseline in SF36 at 6 weeks)
- MDSAI(Change from baseline over time (1,2,3,4,5,6 weeks))
研究者
Mary Jarden
Research Fellow
Universitetshospitalernes Center for Sygepleje
研究点 (2)
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