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CompletedNCT02828553Updated Aug 30, 2019

CHF Inpatient Ambulation Trial

An observational study in Heart Failure, sponsored by Lancaster General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Lancaster General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
352
Ages
18 Years and older
Sex
All
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Study summary

There is an overwhelming amount of deconditioning that occurs during the hospitalization to a patient admitted with a primary diagnosis of congestive heart failure. The goals of this study are to determine if monitored activity and aggressive mobility provides improved outcomes in hospitalized heart failure patients.

Read the detailed description

By implementing an ambulatory study, the goal is to decrease the hospital length of stay by half of a day, decrease the percentage of patients being discharged to an extended nursing care facility, and improve quality of life for the patient. Fiscal year 2014 the average length of stay for a CHF patient at Lancaster General Health was 6.0, and as of fiscal year 2015 this was decreased to 5.8. According to Harlan M Krumbholz's theory of post hospital syndrome, patients are subjected to a time of increased risk of impaired stamina, coordination, strength and readmission for about thirty days after discharge due to deconditioning during their hospitalization. By implementing the ambulatory study, the hope is to prevent such extensive deconditioning to help improve the patient's quality of life after discharge; thereby reducing length of stay, discharges to skilled nursing facilities, 30 day readmissions and costs.

The advent of wearable activity and/or health monitors in the health and fitness industry segment has the potential to revolutionize the industry. More importantly, these devices allow new variables to be collected to provide an impact on patients' care and outcome such as steps taken per day.

The intention of the ambulation study is to prevent hospital acquired deconditioning; which in turn would not only decrease the length of stay, but also improve the discharge disposition and place them at home rather than hospice, an extended care facility or rehab. Not only is the intent of the study to decrease the length of stay and also improve the patient's disposition, but also improve their quality of life. In addition, the study will test the effectiveness of the addition of a mobility aide to assist with patients walking on the nursing units.

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Conditions studied

  • Heart Failure

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Keywords

  • Wearable device
  • Fitbit
  • Inpatient
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In context

Heart Failure

5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 352 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Lancaster General Hospital is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients entering the Lancaster General Hospital heart failure unit (5 East or 5 West) will be evaluated with a 2 minute walk test and if able to complete this test will be offered the opportunity to enroll/consent for participation.

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

  • Diagnosis of heart failure
  • The heart group as attending or consultant
  • Patient on 5 West at the time of admission
  • Admission diagnosis of heart failure
  • Age ≥ 18
  • Initial assessment completed within 10 hours of admission by a registered nurse

Exclusion criteria

Exclusion Criteria:

  • Patient admitted from acute rehabilitation or skilled nursing facility
  • Altered weight bearing or unable to complete initial 2 minute walk test
  • Unwilling or unable to participate or consent
  • Acute delirium or dementia by history
  • Hospice or actively dying
  • Ventricular assist device or listed for heart transplantation
  • Inotrope dependence
  • Active ischemia
  • Heart rate (HR) \<50 or >130 at rest
  • Blood pressure (BP) \<80 or >180 at rest
  • Pulse oximetry \<88% at rest
  • Patient is in isolation for multi-drug resistant organism such as MRSA or C-diff
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
352 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control Group - Usual Care

    At the start of the study, subjects will be enrolled in usual care when admitted to the heart failure unit following standard protocols.

  • Intervention Group - Aggressive Ambulation

    After a washout period and transition to a new aggressive ambulation protocol, subjects will be enrolled to usual care + aggressive planned ambulation with a trained mobility aide.

    Other: Aggressive planned ambulation with a mobility aide

Interventions

  • OtherAggressive planned ambulation with a mobility aide

    A trained mobility aide will provide aggressive ambulation at least 3X per day for all patients on the heart failure unit

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What researchers measure

Primary outcomes

  1. Walk distance

    Walk distance using a 2-minute walk test will be assessed at admission and again at discharge. A clear starting and stopping point will be made with distance marked every 10 feet. A chair with armrests will be at the starting and stopping point of the walk distance. The designated area will be between 5 East and 5 West which will be standard for each patient. After the assessment the nurse will document the total patient's distance to the nearest 10 feet. Example "Ms. Smith walked 100 feet with 3 stops in 2 minutes." The patient will have a repeat 2 minute walk test on the day of discharge using the same criteria. For the walk test: * Gait belt must be used * Patient will be allowed to stop, lean on the wall and rest, but if requires sitting, terminates the 2 minute walk distance. * IV medications on hold is able

    Time frame: Through study completion, an average of 5 days

  2. Steps per day

    Steps per day for each day in the hospital will be measured in 15-minute intervals from admission to discharge using a Fitbit device (wearable device on the wrist). Data will be downloaded from the Fitbit upon discharge.

    Time frame: Through study completion, an average of 5 days

Secondary outcomes

  1. Disposition at Discharge

    Discharge disposition to home, skilled care/nursing care, etc. will be tracked.

    Time frame: At discharge/completion of study; an average of 5 days after admission

  2. Readmission within 30 days

    Readmission within 30 days of discharge

    Time frame: 30 Days after discharge

  3. Falls

    Record any falls or near falls for subjects enrolled in the study during hospital stay from admission to discharge

    Time frame: Through study completion, an average of 5 days

  4. Length of Stay

    Calculation of length of stay from hour/day of admission to hour/day of discharge

    Time frame: Through study completion, an average of 5 days

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Study locations

1 site
  • Lancaster General Hospital
    Lancaster, Pennsylvania 17604, United States
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References and documents

Individual participant data

Plan to share: No — Study results will be published in aggregate.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02828553
Lead sponsor
Lancaster General Hospital
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Oct 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Aug 30, 2019

Study contacts

Justin Roberts, DO
principal investigator · Lancaster General Hospital
Lisa Rathman, CRNP
principal investigator · Lancaster General Hospital
Dana Irwin, BSN, RN
principal investigator · Lancaster General Hospital
Michael Killinger, MSN, RN
principal investigator · Lancaster General Hospital
Nathaniel Baker, DPT
principal investigator · Lancaster General Hospital
Michael Horst, PhD
principal investigator · Lancaster General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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