NCT05815017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 29, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

March 8, 2023

Results QC Date

January 8, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Artificial Intelligence (AI)Physical TherapyHospitalization related muscle atrophyHospitalization associated declineInpatient rehabilitationAI driven physical therapy

Outcome Measures

Primary Outcomes (3)

  • % of Participants Who Reported "Yes" to Enjoying Their Work Out and Believing They Benefited From the Activity for Intervention Group Questionnaire.

    % Of participants who reported "yes" to enjoying their work out and believed they benefited from the activity. These are two questions from the survey that were combined. Scale includes "Yes", "Maybe", "No" as possible responses.

    Collected daily at the end of each workout. Survey responses were averaged for each participant.

  • Mean Software Utilization Time for Intervention Group (Change is Being Assessed)

    Mean Software Utilization Time for Intervention Group was calculated by taking the mean of daily minutes per exercise session per participant, and then calculating the mean minutes utilization time for all participants.

    Collected daily throughout duration of patient hospitalization, usually 1-2 weeks, Daily minutes were averaged over sessions

  • Average Exercise Repetitions Completed for Intervention Group

    Completed exercise repetitions per patient were calculated by taking the mean of each participant's daily exercise repetitions and then calculating a mean of all participants.

    Collected daily throughout duration of patient hospitalization, usually 1-2 weeks

Secondary Outcomes (3)

  • Average Change in Activity Measure for Post Acute Care (AMPAC) Scores

    Collected daily throughout duration of patient hospitalization, usually 1-2 weeks, Daily scores were averaged

  • Length of Hospital Stay

    Collected at the time of discharge of patient hospitalization, usually 1-2 weeks

  • Discharged Home

    Collected at time of discharge, usually 1-2 weeks

Study Arms (2)

Gamified Physical Therapy Exercise Software Intervention + Usual Care

EXPERIMENTAL

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.

Device: Yoomi Physical Therapy Software

Usual Care

NO INTERVENTION

Usual Care

Interventions

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.

Gamified Physical Therapy Exercise Software Intervention + Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \>= 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Muscle WeaknessMuscular AtrophyAstheniaIatrogenic DiseaseSedentary Behavior

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsAtrophyPathological Conditions, AnatomicalDisease AttributesBehavior

Results Point of Contact

Title
Dr Jay Naik
Organization
Rutgers Robert Wood Johnson Medical School

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 18, 2023

Study Start

November 29, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

August 7, 2026

Results First Posted

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations