Clinical trial NCT02796196: Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant
Official title: Effects of Prescribed Physical Activity on Sleep and Performance in Hematopoietic Cell Transplantation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cell Transplantation
Keywords: Hematopoietic
Recipient
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Stem Cell Transplant at Stanford Hospital.

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.

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).

Eligibility 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

Primary outcomes:
measure: ECOG performance scores
timeFrame: At baseline
measure: KPS performance scores
timeFrame: At baseline
measure: Minutes of aerobic activity per day
timeFrame: Up to time of hospital discharge, or 29 days
measure: Minutes of sleep per day
timeFrame: Up to time of hospital discharge, or 29 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: André Valdez
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Matthew Smuck
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Kota Reichert
role: PRINCIPAL_INVESTIGATOR
References: