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

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.

Study Overview

• Status: Completed
• Conditions: Cell Transplantation
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Stem Cell Transplant at Stanford Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Chart Review; Device: Monitoring Device; Wearable physical activity monitoring device; Other Names: Monitor; Procedure: Physical Therapy; Undergo primarily self-directed physical therapy; Other Names: PT; Physiatric Procedure; Physical Medicine Procedure; Physical Therapeutics; Physical Therapy Procedure; Physiotherapy; Physiotherapy Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECOG performance scores	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.	At baseline
KPS performance scores	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.	At baseline
Minutes of aerobic activity per day	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).	Up to time of hospital discharge, or 29 days
Minutes of sleep per day	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).	Up to time of hospital discharge, or 29 days

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: André Valdez, Stanford University; Principal Investigator: Matthew Smuck, Stanford University; Principal Investigator: Kota Reichert, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Hematopoietic; Recipient
• Additional Relevant MeSH Terms: Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: IRB-35379 (Other Identifier: Stanford IRB); NCI-2016-00737 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); VAR0137 (Other Identifier: Stanford Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No