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

NCT02796196 | Completed

• 3 other identifiers: IRB-35379NCI-2016-00737VAR0137
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cell Transplantation

Keywords

Hematopoietic; Recipient

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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; Device: Monitoring Device; Procedure: Physical Therapy

Interventions

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Supportive care (monitoring device, medical chart review)

Monitoring Device DEVICE

Wearable physical activity monitoring device

Also known as: Monitor

Supportive care (monitoring device, medical chart review)

Physical Therapy PROCEDURE

Undergo primarily self-directed physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Supportive care (monitoring device, medical chart review)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing Stem Cell Transplant at Stanford Hospital.

You may qualify if:

• 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

You may not qualify if:

• Unable to wear a physical activity monitor throughout hospital stay

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Monitoring, Physiologic; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Therapeutics; Rehabilitation

Study Officials

• André Valdez

  Stanford University

  PRINCIPAL INVESTIGATOR

• Matthew Smuck

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kota Reichert

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 10, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)