Feasibility StudiesPAVENCT07189286
Preserving Ability Through Virtual Exercise (PAVE)
A study testing PAVE intervention in people with Feasibility Studies, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- PAVE intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in the last 72 hours, they were admitted to the medical floor that is the setting of the study,
- are 55 years or older,
- their bedside nurse approves their physical activity participation in this study
Who cannot join
- they are unable to pass the Evaluation to Sign Consent Measure,
- they score 20 or lower on the Montreal Cognitive Assessment Basic,
- they have an admitting diagnosis that could be worsened through virtual reality exercise,
- they have an attached medical device that decreases the safety of physical activity such as a nasogastric tube or continuous fluids running through a PICC line that cannot be paused,
- they are unable to follow commands or move their extremities against gravity during the UMove Mobility Assessment,
- they are unable to wear the virtual reality headset,
Show all 9Show fewer
- they received the education control intervention or PAVE intervention during a prior admission,
- there is an active plan to discharge this patient during day of recruitment or the following day,
- they are on airborne or droplet precautions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UMMC Midtown Campus
Baltimore, Maryland, 21201
Gyasi Moscou-Jackson, PhD, MHS, RN, 410-328-8893, gyasi.moscoujackson@umm.edu
About this study
Official title: Preserving Ability Through Virtual Exercise (PAVE): An Intervention to Increase the Physical Activity of Hospitalized Older Adults
Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention at helping older adults engage in physical activity and maintain physical function and mental health during their hospital stay. As virtual reality technology becomes more affordable and ubiquitously available across the world, this study will demonstrate how this technology could be leveraged to maintain the function of older adults in the hospital.
Read the detailed description
Older adults (≥60 years) experience multi-level barriers to physical activity when hospitalized. Patient level barriers to physical activity when hospitalized include tethers (e.g., foley catheters, intravenous infusions), symptoms of their acute illness (e.g., pain, fatigue), low self-efficacy to perform physical activity, and a perception that they should remain on bedrest when hospitalized. Interpersonal barriers to physical activity, highlighted during this post pandemic environment, include staffing shortages and increased patient acuity, which can force nurses to prioritize other critical tasks over the physical activity of their patients. Environmental barriers to physical activity include bed alarms and a hospital climate that is hyper focused on the incorrect assumption that physical activity increases fall risk among hospitalized older adults.
This lack of physical activity in the hospital generates major personal and societal costs. Each day a patient spends in the hospital increases their risk of functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. Hospital associated deconditioning increases the length of hospital stays, and increases the susceptibility of patients to delirium, falls, and re-admission. Such complications ultimately increase health care costs. Therefore, there is a significant unmet need to identify strategies to increase older patients' physical activity while minimizing staff burden.
The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention to engage older adults in physical activity and maintain physical function and mental health during their hospital stay. This quasi-experimental study has two aims.
Primary) Aim 1: Using the NIH Behavior Change consortium guidelines, the Acceptability/Appropriateness of Intervention Measure, the Simulator Sickness Questionnaire, and semi-structured individual interviews, determine the feasibility of a virtual reality intervention among hospitalized older adults.
Aim 2: Test the preliminary efficacy of the PAVE intervention on 1) time spent in physical activity during the hospital stay, 2) maintenance of physical function, and 3) maintenance of mental health, compared to the education only control group.
Hypothesis 2.1. Patients exposed to the PAVE intervention will demonstrate more time spent in physical activity (MotionWatch, Modified Physical Activity Vital Sign) during their hospital stay, when compared to those exposed to the education control, controlling for appropriate covariates.
Hypothesis 2.2. Patients exposed to the PAVE intervention will better maintain their physical function throughout their hospital stay (Barthel Index, UMove), when compared to those exposed to the education control, controlling for appropriate covariates.
Hypothesis 2.3. Patients exposed to the PAVE intervention will better maintain their mental health throughout their hospital stay (Hospital Anxiety and Depression Scale, Brief Reslience Scale), when compared to those exposed to the education control, controlling for appropriate covariates.
- Conditions
- Feasibility Studies
- Being tested
- PAVE intervention, Education control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAVE interventionBehavioural
Also called virtual reality physical activity
The commercial virtual reality app that will be used for the intervention, Supernatural, provides participants a trainer as they use their arms and legs (e.g., seated knee strikes) to smash targets to 500+ musical tracks. In this manner, this study employs fun as a motivator for exercise commencement and adherence while hospitalized. The research assistant will implement the intervention using the three-step approach including: (1) patient mobility screen, (2) orientation to the technology and intervention, and (3) ongoing assessment, adaptation, and motivation.
Education controlBehavioural
Education control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet.
| Study group | Role | What they receive |
|---|---|---|
| PAVE intervention | Experimental | PAVE participants will be trained to use the virtual reality headset and perform virtual reality physical activity throughout their hospital stay. Receives: Behavioral: PAVE intervention |
| Education control | Active comparator | Education control will receive physical activity education using the NIH "Get Fit for Life" booklet. Receives: Behavioral: Education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Acceptability of Intervention Measure
Scores range from 4-20, with higher scores indicating greater acceptability of intervention
Measured: measured at discharge or 7 days post baseline, whichever occurs first
Feasibility: Appropriateness of Intervention Measure
Scores range from 4-20, with higher scores indicating greater appropriateness of intervention
Measured: measured at discharge or 7 days post baseline, whichever occurs first
Feasibility: Simulator Sickness Questionnaire
Scores range from 0 to 48, with higher score indicating more simulator sickness.
Measured: measured following PAVE participants' first virtual reality session only; baseline only
Feasibility: Qualitative Interviews
The interviews will include the following four questions: (1) "What did you like best about the virtual reality physical activity intervention?", (2) "What did you like least about the virtual reality physical activity intervention?", (3) "How, if at all, did participating in the virtual reality exercises affect the way you coped with challenges during your hospital stay?" and (4) "How could this virtual reality physical activity intervention be improved?"
Measured: measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)
Secondary outcomes (6)
Physical Activity
The MotionWatch8 is a lightweight, wrist-worn activity monitoring device with a battery that lasts approximately one month. The MotionWatch8 contains a valid and reliable accelerometer, which records physical movement of the wrist providing a close correlation to whole body movement (1-minute epochs, 50 Hz). We will quantify counts of activity into sedentary, light, moderate, and vigorous activity per day (as defined by Landry and colleagues, 2015, Front Aging Neurosci).
Measured: At baseline enrollment, we will apply the MotionWatch8 to participants' wrists. At discharge, or 7 days after baseline, whichever occurs first, we will remove the MotionWatch8.
Physical Activity: Modified Physical Activity Vital Sign
The modified Physical Activity Vital sign measures patients' self-report participation in physical activity. The 6 items gather if (yes/no) activity was performed, duration (in minutes), and intensity (ordinal 0-10, with higher scores indicating higher intensity) for movement and strength based activities within the last 24 hours.
Measured: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Physical Function: Barthel Index
Barthel Index. Scores range from 0-100, with higher scores indicating greater independence.
Measured: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Physical Function: UMove Mobility Screen
The UMove Mobility Scale is a clinical screening tool designed to help healthcare providers assess a patient's functional mobility and determine safe strategies for out-of-bed movement and ambulation. While there is no fixed numerical range, patients are categorized into mobility levels 1-5.
Measured: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Mental Health: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale: Scores range from 0-21, with higher score indicating greater mental illness.
Measured: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Brief Resilience Scale
The Brief Resilience Scale is a 6-item ordinal scale that measures resilience. Greater scores indicate higher resilience. Scores range from 6-30, with higher scores indicating higher resilience.
Measured: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start1 Feb 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This proposed study, Preserving Ability through Virtual Exercise (PAVE), will be a quasi-experimental trial among hospitalized older adults. We plan to recruit the 140 participants from one medical floor, with 70 in the intervention group and 70 in the control group. Recruitment will occur in blocks. First, during the pilot phase, we will recruit 10 intervention participants and then 10 control participants, followed by a temporary pause in recruitment to assess feasibility data and identify any needed protocol refinements. If any refinements are needed, we will submit an IRB modification. Next, we will resume recruitment of 30 intervention and then 30 control participants, followed by 30 intervention and then 30 control participants. Randomizing participants within unit is not feasible because control participants could be exposed to the intervention by observing or interacting with intervention participants (e.g., roommates performing the intervention.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), The Claude D. Pepper Older Americans Independence Centers
- Responsible party
- Principal investigator, Brittany Burch, University of Maryland, Baltimore
- Investigators
- Brittany Burch, PhD, MSN, RN, Principal investigator, University of Maryland Baltiomre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189286
- Sponsor's protocol ID
- 1K01AG090761-01A1
- Other IDs
- 1K01AG090761-01A1
- Acronym
- PAVE
- Status last verified
- Apr 2026
- First submitted
- 9 Sep 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: During informed consent, study participants will be asked to consent to de-identified quantitative data sharing upon recommendations of the local IRB. We will share all collected quantitative data in a de-identified format (age, comorbidities, feasibility, physical activity, physical function, and mental health), removing all personal identifying information. All direct participant identifiers (e.g., name, date of birth) will be removed from data prior to sharing. Users of the generalist repository that will store this study's data, Zenodo, must agree to the Terms and Conditions of Zenodo, and agree not to share or redistribute the data. We will not share the transcripts from the qualitative individual interviews.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserving Ability Through Virtual Exercise (PAVE): An Intervention to Increase the Physical Activity of Hospitalized Older Adults
- ClinicalTrials.gov ID
- NCT07189286
- Acronym / sponsor ID
- PAVE / 1K01AG090761-01A1
- Conditions
- Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), The Claude D. Pepper Older Americans Independence Centers
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Each day in the hospital leads to functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention at helping older adults engage in physical activity and maintain physical function and mental health during their hospital stay. As virtual reality technology becomes more affordable and ubiquitously available across the world, this study will demonstrate how this technology could be leveraged to maintain the function of older adults in the hospital.
Detailed description
Older adults (≥60 years) experience multi-level barriers to physical activity when hospitalized. Patient level barriers to physical activity when hospitalized include tethers (e.g., foley catheters, intravenous infusions), symptoms of their acute illness (e.g., pain, fatigue), low self-efficacy to perform physical activity, and a perception that they should remain on bedrest when hospitalized. Interpersonal barriers to physical activity, highlighted during this post pandemic environment, include staffing shortages and increased patient acuity, which can force nurses to prioritize other critical tasks over the physical activity of their patients. Environmental barriers to physical activity include bed alarms and a hospital climate that is hyper focused on the incorrect assumption that physical activity increases fall risk among hospitalized older adults.
This lack of physical activity in the hospital generates major personal and societal costs. Each day a patient spends in the hospital increases their risk of functional decline and loss of muscle mass, which older adults can find difficult or impossible to restore in the post-acute period. Hospital associated deconditioning increases the length of hospital stays, and increases the susceptibility of patients to delirium, falls, and re-admission. Such complications ultimately increase health care costs. Therefore, there is a significant unmet need to identify strategies to increase older patients' physical activity while minimizing staff burden.
The overall objective of this proposed project is to explore the feasibility and preliminary efficacy of a virtual reality physical activity intervention to engage older adults in physical activity and maintain physical function and mental health during their hospital stay. This quasi-experimental study has two aims.
Primary) Aim 1: Using the NIH Behavior Change consortium guidelines, the Acceptability/Appropriateness of Intervention Measure, the Simulator Sickness Questionnaire, and semi-structured individual interviews, determine the feasibility of a virtual reality intervention among hospitalized older adults.
Aim 2: Test the preliminary efficacy of the PAVE intervention on 1) time spent in physical activity during the hospital stay, 2) maintenance of physical function, and 3) maintenance of mental health, compared to the education only control group.
Hypothesis 2.1. Patients exposed to the PAVE intervention will demonstrate more time spent in physical activity (MotionWatch, Modified Physical Activity Vital Sign) during their hospital stay, when compared to those exposed to the education control, controlling for appropriate covariates.
Hypothesis 2.2. Patients exposed to the PAVE intervention will better maintain their physical function throughout their hospital stay (Barthel Index, UMove), when compared to those exposed to the education control, controlling for appropriate covariates.
Hypothesis 2.3. Patients exposed to the PAVE intervention will better maintain their mental health throughout their hospital stay (Hospital Anxiety and Depression Scale, Brief Reslience Scale), when compared to those exposed to the education control, controlling for appropriate covariates.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This proposed study, Preserving Ability through Virtual Exercise (PAVE), will be a quasi-experimental trial among hospitalized older adults. We plan to recruit the 140 participants from one medical floor, with 70 in the intervention group and 70 in the control group. Recruitment will occur in blocks. First, during the pilot phase, we will recruit 10 intervention participants and then 10 control participants, followed by a temporary pause in recruitment to assess feasibility data and identify any needed protocol refinements. If any refinements are needed, we will submit an IRB modification. Next, we will resume recruitment of 30 intervention and then 30 control participants, followed by 30 intervention and then 30 control participants. Randomizing participants within unit is not feasible because control participants could be exposed to the intervention by observing or interacting with intervention participants (e.g., roommates performing the intervention.
| Arm | Type | Receives |
|---|---|---|
| PAVE intervention | Experimental | Behavioral: PAVE interventionPAVE participants will be trained to use the virtual reality headset and perform virtual reality physical activity throughout their hospital stay. |
| Education control | Active comparator | Behavioral: Education controlEducation control will receive physical activity education using the NIH "Get Fit for Life" booklet. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- in the last 72 hours, they were admitted to the medical floor that is the setting of the study,
- are 55 years or older,
- their bedside nurse approves their physical activity participation in this study
Key exclusion criteria (9 listed)
- they are unable to pass the Evaluation to Sign Consent Measure,
- they score 20 or lower on the Montreal Cognitive Assessment Basic,
- they have an admitting diagnosis that could be worsened through virtual reality exercise,
- they have an attached medical device that decreases the safety of physical activity such as a nasogastric tube or continuous fluids running through a PICC line that cannot be paused,
- they are unable to follow commands or move their extremities against gravity during the UMove Mobility Assessment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAVE interventionAlso: virtual reality physical activityThe commercial virtual reality app that will be used for the intervention, Supernatural, provides participants a trainer as they use their arms and legs (e.g., seated knee strikes) to smash targets to 500+ musical tracks. In this manner, this study employs fun as a motivator for exercise commencement and adherence while hospitalized. The research assistant will implement the intervention using the three-step approach including: (1) patient mobility screen, (2) orientation to the technology and intervention, and (3) ongoing assessment, adaptation, and motivation. | Behavioural | PAVE intervention |
| Education controlEducation control participants will receive and physical activity education using the NIH "Get Fit for Life" booklet. | Behavioural | Education control |
Primary outcome
Feasibility: Acceptability of Intervention Measure
Time frame: measured at discharge or 7 days post baseline, whichever occurs first
Scores range from 4-20, with higher scores indicating greater acceptability of intervention
Feasibility: Appropriateness of Intervention Measure
Time frame: measured at discharge or 7 days post baseline, whichever occurs first
Scores range from 4-20, with higher scores indicating greater appropriateness of intervention
Feasibility: Simulator Sickness Questionnaire
Time frame: measured following PAVE participants' first virtual reality session only; baseline only
Scores range from 0 to 48, with higher score indicating more simulator sickness.
Feasibility: Qualitative Interviews
Time frame: measured at discharge or 7 days post baseline, whichever occurs first (PAVE participants only)
The interviews will include the following four questions: (1) "What did you like best about the virtual reality physical activity intervention?", (2) "What did you like least about the virtual reality physical activity intervention?", (3) "How, if at all, did participating in the virtual reality exercises affect the way you coped with challenges during your hospital stay?" and (4) "How could this virtual reality physical activity intervention be improved?"
6 secondary outcomes
Physical Activity
Time frame: At baseline enrollment, we will apply the MotionWatch8 to participants' wrists. At discharge, or 7 days after baseline, whichever occurs first, we will remove the MotionWatch8.
Physical Activity: Modified Physical Activity Vital Sign
Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Physical Function: Barthel Index
Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Physical Function: UMove Mobility Screen
Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Mental Health: Hospital Anxiety and Depression Scale
Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Brief Resilience Scale
Time frame: Measured at baseline and discharge, or 7 days post baseline, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. During informed consent, study participants will be asked to consent to de-identified quantitative data sharing upon recommendations of the local IRB. We will share all collected quantitative data in a de-identified format (age, comorbidities, feasibility, physical activity, physical function, and mental health), removing all personal identifying information. All direct participant identifiers (e.g., name, date of birth) will be removed from data prior to sharing. Users of the generalist repository that will store this study's data, Zenodo, must agree to the Terms and Conditions of Zenodo, and agree not to share or redistribute the data. We will not share the transcripts from the qualitative individual interviews.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brittany Burch, PhD, MSN, RN principal investigator
University of Maryland Baltiomre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAVE intervention in people with Feasibility Studies, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brittany Burch, PhD, MSN, RN (4107063770 ext. 63770, bfburch@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Acceptability of Intervention Measure (time frame: measured at discharge or 7 days post baseline, whichever occurs first). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.