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

NCT ID: NCT02796196

Last Updated: 2018-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-03-01

Brief Summary

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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

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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).

Conditions

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Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Medical Chart Review

Intervention Type OTHER

Review of medical chart

Monitoring Device

Intervention Type DEVICE

Wearable physical activity monitoring device

Physical Therapy

Intervention Type PROCEDURE

Undergo primarily self-directed physical therapy

Interventions

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Medical Chart Review

Review of medical chart

Intervention Type OTHER

Monitoring Device

Wearable physical activity monitoring device

Intervention Type DEVICE

Physical Therapy

Undergo primarily self-directed physical therapy

Intervention Type PROCEDURE

Other Intervention Names

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Chart Review Monitor Physiatric Procedure Physical Medicine Procedure Physical Therapeutics Physical Therapy Procedure Physiotherapy Physiotherapy Procedure PT

Eligibility Criteria

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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

* Unable to wear a physical activity monitor throughout hospital stay
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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André Valdez

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Matthew Smuck

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Kota Reichert

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University, School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2016-00737

Identifier Type: REGISTRY

Identifier Source: secondary_id

VAR0137

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35379

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35379

Identifier Type: -

Identifier Source: org_study_id

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