Prescribed Physical Activity in Improving Sleep and Physical Performance in Patients Undergoing Stem Cell Transplant
27 november 2018 uppdaterad av: Stanford University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
75
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304
- Stanford University, School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients undergoing Stem Cell Transplant at Stanford Hospital.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
Genomgång av medicinskt diagram
Andra namn:
Wearable physical activity monitoring device
Andra namn:
Undergo primarily self-directed physical therapy
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
ECOG performance scores
Tidsram: 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.
|
At baseline
|
|
KPS performance scores
Tidsram: 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.
|
At baseline
|
|
Minutes of aerobic activity per day
Tidsram: 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).
|
Up to time of hospital discharge, or 29 days
|
|
Minutes of sleep per day
Tidsram: 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).
|
Up to time of hospital discharge, or 29 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: André Valdez, Stanford University
- Huvudutredare: Matthew Smuck, Stanford University
- Huvudutredare: Kota Reichert, Stanford University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2016
Primärt slutförande (Faktisk)
1 mars 2017
Avslutad studie (Faktisk)
1 mars 2017
Studieregistreringsdatum
Först inskickad
1 juni 2016
Först inskickad som uppfyllde QC-kriterierna
9 juni 2016
Första postat (Uppskatta)
10 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 november 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 november 2018
Senast verifierad
1 november 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-35379 (Annan identifierare: Stanford IRB)
- NCI-2016-00737 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- VAR0137 (Annan identifierare: Stanford Cancer Institute)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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