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

Cell Transplantation Clinical Trial

Official title:

Effects of Prescribed Physical Activity on Sleep and Performance in Hematopoietic Cell Transplantation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796196
• Other study ID #: IRB-35379
• Secondary ID: NCI-2016-00737VA
• Status: Completed
• Start date: May 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 1, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cell Transplantation

Intervention

Other:
• Medical Chart Review
Review of medical chart

Device:
• Monitoring Device
Wearable physical activity monitoring device

Procedure:
• Physical Therapy
Undergo primarily self-directed physical therapy

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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