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Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT02796196
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
This research trial studies prescribed physical activity in improving sleep and physical performance in patients undergoing stem cell transplant. A wearable physical activity monitor can be used to record minutes of activity and sleep. Gathering data over time using a physical activity monitor may help doctors learn if prescribed physical activity helps improve sleep and physical performance in patients undergoing stem cell transplant.

Condition or disease Intervention/treatment
Cell Transplantation Other: Medical Chart Review Device: Monitoring Device Procedure: Physical Therapy

Detailed Description:

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).


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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Prescribed Physical Activity on Sleep and Performance in Hematopoietic Cell Transplantation Patients
Actual Study Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Medical Chart Review
Review of medical chart
Other Name: Chart Review

Device: Monitoring Device
Wearable physical activity monitoring device
Other Name: Monitor

Procedure: Physical Therapy
Undergo primarily self-directed physical therapy
Other Names:
  • Physiatric Procedure
  • Physical Medicine Procedure
  • Physical Therapeutics
  • Physical Therapy Procedure
  • Physiotherapy
  • Physiotherapy Procedure
  • PT




Primary Outcome Measures :
  1. ECOG performance scores [ Time Frame: 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.

  2. KPS performance scores [ Time Frame: 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.

  3. Minutes of aerobic activity per day [ Time Frame: 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).

  4. Minutes of sleep per day [ Time Frame: Up to time of hospital discharge, or 29 days ]
    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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Stem Cell Transplant at Stanford Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796196


Locations
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United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: André Valdez Stanford University
Principal Investigator: Matthew Smuck Stanford University
Principal Investigator: Kota Reichert Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02796196     History of Changes
Other Study ID Numbers: IRB-35379
NCI-2016-00737 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VAR0137 ( Other Identifier: Stanford Cancer Institute )
IRB-35379 ( Other Identifier: Stanford IRB )
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stanford University:
Hematopoietic
Recipient