Cell TransplantationNCT02796196
Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant
An observational study of Cell Transplantation, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cell Transplantation
- What is being tested?
- Medical Chart Review, Monitoring Device and Physical Therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 1 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing Stem Cell Transplant at Stanford Hospital.
Who may be able to join
- 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
Who cannot join
- Does not meet inclusion criteria
- Unable to wear a physical activity monitor throughout hospital stay
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Palo Alto, California, 94304
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Cell Transplantation
- Being tested
- Medical Chart Review, Monitoring Device, Physical Therapy
- Keywords
- Hematopoietic, Recipient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
Monitoring DeviceDevice
Also called Monitor
Wearable physical activity monitoring device
Physical TherapyProcedure or surgery
Also called Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure
Undergo primarily self-directed physical therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical Chart Review; Device: Monitoring Device; Procedure: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Up to time of hospital discharge, or 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Valdez, Principal investigator, Stanford UniversityMatthew Smuck, Principal investigator, Stanford UniversityKota Reichert, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796196
- Sponsor's protocol ID
- IRB-35379
- Other IDs
- NCI-2016-00737, VAR0137, IRB-35379
- Status last verified
- Nov 2018
- First submitted
- 1 Jun 2016
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prescribed Physical Activity on Sleep and Performance in Hematopoietic Cell Transplantation Patients
- ClinicalTrials.gov ID
- NCT02796196
- Acronym / sponsor ID
- IRB-35379
- Conditions
- Cell Transplantation
- Keywords
- Hematopoietic, Recipient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (monitoring device, medical chart review) | – | Other: Medical Chart Review, Device: Monitoring Device, Procedure: Physical TherapyData 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing Stem Cell Transplant at Stanford Hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Does not meet inclusion criteria
- Unable to wear a physical activity monitor throughout hospital stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Supportive care (monitoring device, medical chart review) |
| Monitoring DeviceAlso: MonitorWearable physical activity monitoring device | Device | Supportive care (monitoring device, medical chart review) |
| Physical TherapyAlso: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy ProcedureUndergo primarily self-directed physical therapy | Procedure or surgery | Supportive care (monitoring device, medical chart review) |
Primary outcome
ECOG performance scores
Time frame: At baseline
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.
KPS performance scores
Time frame: At baseline
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.
Minutes of aerobic activity per day
Time frame: Up to time of hospital discharge, or 29 days
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).
Minutes of sleep per day
Time frame: Up to time of hospital discharge, or 29 days
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Valdez principal investigator
Stanford University
Matthew Smuck principal investigator
Stanford University
Kota Reichert principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cell Transplantation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECOG performance scores (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.