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
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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California
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Palo Alto、California、アメリカ、94304
- Stanford University, School of Medicine
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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カルテの見直し
他の名前：
Wearable physical activity monitoring device
他の名前：
Undergo primarily self-directed physical therapy
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ECOG performance scores
時間枠：At baseline
|
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
時間枠：At baseline
|
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
時間枠：Up to time of hospital discharge, or 29 days
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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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：André Valdez、Stanford University
- 主任研究者：Matthew Smuck、Stanford University
- 主任研究者：Kota Reichert、Stanford University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IRB-35379 (その他の識別子：Stanford IRB)
- NCI-2016-00737 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- VAR0137 (その他の識別子：Stanford Cancer Institute)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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