YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility (YOOMI)

March 6, 2024 updated by: Jay Naik MD, Rutgers, The State University of New Jersey
Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • >= 65 years of age
  • English-fluency in reading and speaking
  • Capacity to consent
  • Enrolled in HELP program
  • Attending physician confirms there are no medical contraindications to in-bed exercises

Exclusion Criteria:

  • Unstable Psychiatric Illness
  • Unstable/Critically Ill Patients requiring ICU-level of care
  • Surgical tube present (e.g. JP drains)
  • Surgery during the hospitalization
  • Bed Rest Activity Order

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Gamified Physical Therapy Exercise Software Intervention + Usual Care
Participants randomized to the intervention group will be asked each day by a volunteer whether they would like to use the gamified physical therapy exercise software while in their beds. Participants willing to exercise will have the device set up for them to participate by a volunteer and the software will begin with a tutorial video for different exercises and then ask patients to perform in sequence with prompting and motion tracking. Exercises include Frontal Bicep Curls, Arm Crosses, Press Ups, Arm Rotations, and Basketball Shots.
Physical Therapy software via a computer/monitor will be set up for the patient. It will begin with a tutorial video for different exercises in the form of games and then ask patients to perform in sequence with prompting and motion tracking. Exercises include Frontal Bicep Curls, Arm Crosses, Press Ups, Arm Rotations, and Basketball Shots.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Score for Intervention Group Questionnaire (change is being assessed)
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Software Utilization Time for Intervention Group (change is being assessed)
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Percentage of exercise repetitions completed for Intervention Group (change is being assessed)
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Completed exercises divided by assigned exercises by software
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Self-Assessments
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Activity Measure for Post Acute Care (AMPAC) scores done as self-assessments (Score ranging from 0 to 24 with higher being better)
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
3DCAM Delirium Scale
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
22 questions including self reported and observations by staff to determine if patient has delirium
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Change in Activity Measure for Post Acute Care (AMPAC) Scores
Time Frame: Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Activity Measure for Post Acute Care (AMPAC) scores done by nurses twice daily (Score ranging from 0 to 24 with higher being better)
Collected daily throughout duration of patient hospitalization, usually 1-2 weeks
Length of hospital stay
Time Frame: Collected at the time of discharge of patient hospitalization, usually 1-2 weeks
Collected at the time of discharge of patient hospitalization, usually 1-2 weeks
Post-discharge care needs
Time Frame: Collected at time of discharge, usually 1-2 weeks
Number of Partipants with Post-discharge needs e.g. subacute rehab, home PT, home assistance, acute rehab, etc
Collected at time of discharge, usually 1-2 weeks
Post-discharge Self Assessed Activity Measure for Post Acute Care (AMPAC) Score
Time Frame: 30 days post-discharge
AMPAC scores done as self-assessments (Score ranging from 0 to 24 with higher being better)
30 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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