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CompletedNCT04444453EARLYUpdated Jan 17, 2023

Early Ambulation to Reduce Hospital Length of Stay

An interventional study of Wearable Pedometer in Ambulation and Wearable Devices, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by University of Florida · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also reduced adverse events such as venous thromboembolism (VTE). We will test if a patient wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation, decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable pedometer or usual care. Patients randomized to the study intervention will receive a wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study outcome measures to be compared between the pedometer and no pedometer group include hospital LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence of VTEs, patient experience, and costs (secondary outcomes).

02

Conditions studied

  • Ambulation
  • Wearable Devices

Keywords

  • length of stay
  • hospitalization
03

In context

Lead sponsor

University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients ages > or equal to 18 years
  2. Patient has capacity to undergo informed consent
  3. Admitted to UF Health Jacksonville 8N progressive inpatient unit
  4. Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission
  5. Patient with a Fall Predictive Analytics score category of "low risk"
  6. Patient with a Morse Fall Scale (MFS) of \< or equal to 50
  7. No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

Exclusion criteria

Exclusion Criteria:

  1. Patient \< 18 years of age
  2. Patient without capacity to undergo informed consent
  3. Patient with a 'do not ambulate' order or has order for bed rest or other contraindication to ambulation (i.e., fall risk) or dependent on more than minimal assistance to ambulate
  4. Patient with a Fall Predictive Analytics score category of "high risk"
  5. Patient with MFS > 50 or labelled by clinical team as fall risk
  6. Non-English speaking
  7. In law enforcement custody or ward of the state
  8. Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Pedometer

    Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated

    Device: Wearable Pedometer

  • No intervention
    Control

    Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care

Interventions

  • DeviceWearable Pedometer

    Pedometer worn on wrist

    Also known as: Pedometer

06

What researchers measure

Primary outcomes

  1. Hospital Length of Stay

    Time patient is admitted in hospital

    Time frame: Up to 1 month

Secondary outcomes

  1. Hospital length-of-stay index

    Time frame: Up to 1 month

  2. Time to first ambulation

    Time frame: Up to 1 month

  3. Time to first bowel movement

    Time frame: Up to 1 month

  4. Rate of venous thromboembolism

    Time frame: Up to 1 month

  5. Total hospitalization costs

    Time frame: Up to 1 month

07

Study locations

1 site
  • University of Florida
    Jacksonville, Florida 32209, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2020 to primary completion in Aug 2022, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2020
First posted
Jun 23, 2020
StartActual
Oct 21, 2020
Primary completionActual
Aug 1, 2022
CompletionActual
Sep 1, 2022
Last update
Jan 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04444453
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Jun 23, 2020
Start date
Oct 21, 2020
Primary completion
Aug 1, 2022
Completion
Sep 1, 2022
Last update
Jan 17, 2023

Study contacts

Jennifer Fishe, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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