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临床试验/NCT02273024
NCT02273024已完成不适用

Exercise Therapy for Patients Awaiting Allogeneic Hematological Stem Cell Transplantation

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in Physical Function

研究概览

简要总结

The investigators hypothesize that inactivity during the search for a donor may exacerbate current deconditioned states; subsequently, influencing risk factors for post-transplant complications that hinder the recovery phase.

This study is designed to investigate if exercise therapy administered prior to allogeneic hematologic stem cell transplantation (HSCT) can influence physical and psychological side-effects associated with HSCT. Approximately 6-weeks prior to HSCT, individuals will be randomized into either an exercise group or usual care group and followed until one year after HSCT.

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
None

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medical indication: allogeneic stem cell transplantation at Princess Margaret Hospital
  • must be ambulatory without need for human assistance at time of recruitment
  • medically cleared to exercise by the transplant physician
  • demonstrates willingness to attend supervised sessions
  • sufficient in English to ensure safety of understanding prescribed exercise guidelines, or has access to an adequate non-familial interpreter

排除标准

  • another active malignancy
  • less than 4 weeks till the scheduled HSCT
  • refusal to be randomized
  • does not have the approval of their transplant physician
  • severe or unstable neurological, cardiorespiratory, musculoskeletal disease or mental illness

结局指标

主要结局

Change in Physical Function

时间窗: Baseline, 1 week pre HSCT, T100, 1yr post HSCT

Cardiopulmonary Capacity (VO2peak)

次要结局

  • Change in Symptoms(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Treatment Side-effects(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Six-minute walk test(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Quality of Life(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Anxiety(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Depression(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Fatigue(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)
  • Change in Strength(Baseline, 1 week pre HSCT, T100, 1yr post HSCT)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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