Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant
Effects of Prescribed Physical Activity on Sleep and Performance in Hematopoietic Cell Transplantation Patients
研究概览
详细说明
PRIMARY OBJECTIVES:
I. Evaluate whether prescribed physical activity, as part of standard care, improves sleep and functional outcomes in hematopoietic cell transplantation (HCT) (stem cell transplantation) patients during a typical 30-day hospitalization period.
OUTLINE:
Data including demographics, type of HCT (e.g., allogeneic or autologous), preexisting physical conditions (e.g., chronic joint injury), chronic renal failure (CRF), steroid use data, Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status (KPS) scores are collected from patients' medical charts at time of enrollment. Patients are prescribed participation in a primarily self-directed physical activity program which encourages them to spend 6 hours out of bed daily and to perform 30 minutes of light-to-moderate daily aerobic activity. Patients who are able to maintain independent mobility undergo physical therapist assessment 2 times a week until hospital discharge. Patients wear a physical activity monitoring device and daily activity and sleep data are collected continuously during hospital length of stay (LOS).
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Palo Alto、California、美国、94304
- Stanford University, School of Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Admitted to Stanford Hospital for HCT
- Able to provide informed consent
- Speaks language supported by interpretative services
- Able to operate and take care of a physical activity monitor
Exclusion Criteria:
- Does not meet inclusion criteria
- Unable to wear a physical activity monitor throughout hospital stay
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Supportive care (monitoring device, medical chart review)
Data including demographics, type of HCT (e.g., allogeneic or autologous), preexisting physical conditions (e.g., chronic joint injury), CRF, steroid use data, ECOG and KPS scores are collected from patients' medical charts at time of enrollment.
Patients are prescribed participation in a primarily self-directed physical activity program which encourages them to spend 6 hours out of bed daily and to perform 30 minutes of light-to-moderate daily aerobic activity.
Patients who are able to maintain independent mobility undergo physical therapist assessment 2 times a week until hospital discharge.
Patients wear a physical activity monitoring device and daily activity and sleep data are collected continuously during hospital LOS.
|
病历审查
其他名称：
Wearable physical activity monitoring device
其他名称：
Undergo primarily self-directed physical therapy
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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ECOG performance scores
大体时间：At baseline
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Will focus on trends in scores between patients with different durations of activity and sleep.
Results, from both descriptive and inferential analyses, will be presented in table and/or graphical format.
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At baseline
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KPS performance scores
大体时间：At baseline
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Will focus on trends in scores between patients with different durations of activity and sleep.
Results, from both descriptive and inferential analyses, will be presented in table and/or graphical format.
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At baseline
|
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Minutes of aerobic activity per day
大体时间：Up to time of hospital discharge, or 29 days
|
Will use interval-censored regression to estimate distributions of activity from one day to the next.
This repeated-measures analysis with a polynomial model will generate average curves for activity, each spanning average LOS (i.e., activity duration plotted on day one, day two, day three, etc.).
Will also run diagnostics to verify the assumptions of a linear model (e.g., statistical independence of observations and lack of undue influence of outliers on model fit).
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Up to time of hospital discharge, or 29 days
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Minutes of sleep per day
大体时间：Up to time of hospital discharge, or 29 days
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Will use interval-censored regression to estimate distributions of sleep from one day to the next.
This repeated-measures analysis with a polynomial model will generate average curves for sleep, each spanning average LOS (i.e., sleep duration plotted on day one, day two, day three, etc.).
Will use multiple linear regressions to control for potential confounders in predicting sleep duration.
Will also run diagnostics to verify the assumptions of a linear model (e.g., statistical independence of observations and lack of undue influence of outliers on model fit).
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Up to time of hospital discharge, or 29 days
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合作者和调查者
调查人员
- 首席研究员：André Valdez、Stanford University
- 首席研究员：Matthew Smuck、Stanford University
- 首席研究员：Kota Reichert、Stanford University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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