COVID 19NCT04743401
Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
A study testing Tele-exergaming Tablet in people with COVID 19 and Rehabilitation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Conventional in-hospital mobility programs are challenging to deliver to hospitalized infected patients (e.g., COVID-19) due to infection risk to staff, staffing shortages, and potential exposure of other patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID 19, Rehabilitation, Inpatient
- What is being tested?
- Tele-exergaming Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants: Men or women Veterans with COVID-19 or PUI or hospitalized patients with duration of admission anticipated to be greater than 72 hours admitted to MEDVAMC.
- Length of stay: Anticipated length of stay at least 3 days.
- Ambulatory. Self-report of being ambulatory with or without an assistive device in the 2 weeks before admission.
Who cannot join
- ICU admission: The investigators will exclude those admitted to ICU at any point in their hospital stay.
- Admission of observation only: These patients will be excluded as length of stay is usually anticipated to be less than 3 days
- Median life expectancy: Those with imminently terminal (death expected in the next 30 days) will be excluded.
- Cognitive impairment: The investigators will exclude those with delirium, dementia, or severe cognitive impairment
- Medical condition: The investigators will exclude those who have any medical diagnosis deemed by the primary physician to be a contraindication to ambulation (i.e.: unstable from pulmonary embolus, unstable angina, severe hemodynamic instability etc.)
- Foot problem: The investigators will exclude those who have active foot ulcer or infection or major lower extremities amputation.
Show all 12Show fewer
- Vision or hearing problems: The investigators will exclude those with hearing or visual problems that cannot be corrected with medical devices (glasses or hearing aids). Hearing or visual problems can limit their ability to interact with the exergame platform.
- lack of capacity to consent, and inability or unwillingness to participate regularly in the exercise program;
- unable to communicate in English or Spanish, or unlikely to fully comply with the follow-up protocol (e.g., lack of caregiver support to safely perform exercise tasks at home or complete the questionnaires).
- Clarifying exclusion criteria
- Ongoing treatment: The investigators will NOT exclude those who are participating in standard of care physical therapy program (Receipt of Physical Therapy (PT), Occupational Therapy (OT), Speech Therapy (ST), Mental Health (MH), and Social Work (SW) Services). However, the investigators will document these services and will control for it. However, those who are receiving non- standard of care exercise therapy (e.g. other exercise research study) or receiving active intensive or induction therapy for cancer (e.g. undergoing active initial chemotherapy or radiotherapy).
- Others: The investigators will NOT exclude but will document common comorbidities such as pneumonia, heart failure, and chronic obstructive pulmonary disease exacerbations. Pulmonary embolism or acute coronary syndrome maybe included if there is no contraindications like severe hemodynamic instability or active angina.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
About this study
Conventional in-hospital mobility programs are challenging to deliver to hospitalized infected patients (e.g., COVID-19) due to infection risk to staff, staffing shortages, and potential exposure of other patients. This study evaluates a tele-exergame mobility program, a self-administered, game-based exercise intervention guided by foot-worn sensors and step-by-step interactive guidance on a tablet. The platform promotes strength, balance, and flexibility while enhancing patient motivation and engagement through cognitively demanding gamified tasks, with remote supervision and no to minimum direct physical contact.
Read the detailed description
This feasibility randomized controlled trial will recruit 60 COVID-19 patients or persons under investigation admitted to the Michael E. DeBakey VA Medical Center with an anticipated length of stay of at least 3 days.
Participants will be randomized 1:1 to an intervention or control group. Both groups will receive standard of care and will complete a single 3-minute Tele-Exergame session at baseline to evaluate the feasibility and acceptability of self-administered exercise using the platform.
The intervention group will additionally continue the Tele-Exergame mobility program, a self-administered exercise intervention in which foot-worn sensors track body movement and a tablet provides step-by-step interactive guidance, enabling patients to exercise independently without in-person supervision. Sessions will be performed twice daily, lasting 3 to 10 minutes based on patient ability, with a minimum of one session per day for at least three consecutive days during hospitalization. The control group will receive no Tele-Exergame or sensor-based exercise intervention beyond the single baseline session.
Assessments will be completed at baseline, at hospital discharge, and approximately 4 weeks post-discharge via telemedicine or telephone.
Primary Outcome: Feasibility. Feasibility is defined by (1) the ability to independently complete at least one 3-minute Tele-Exergame session (assessed in both groups); (2) exercise dropout within the first three days of inpatient stay in the intervention group, defined as not using the Tele-Exergame on two consecutive days for any reason (only for Intervention group), including withdrawal of consent, unwillingness to continue participation, or any adverse event precluding continued exercise (e.g., death, unconsciousness, or discharge sooner than 3 days after admission); and (3) absence of intervention-related adverse events.
Secondary Outcome: Proof-of-concept effectiveness. Effectiveness is defined by (1) the ability to independently perform instrumental activities of daily living at 4 weeks post hospital discharge and (2) community engagement, defined by life-space mobility.
This contactless mobility program could address limitations of conventional in-hospital mobility programs, enable exploration of digital biomarkers of hospital-acquired deconditioning and cognitive frailty using wearables, and advance remote patient monitoring. Findings may benefit hospitalized Veterans beyond COVID-19, including bedbound patients with limited mobility, by mitigating hospital-acquired complications such as deconditioning, venous thromboembolism, and nosocomial infections, and by accelerating post-hospitalization recovery.
- Conditions
- COVID 19, Rehabilitation, Inpatient, Hospitalized
- Being tested
- Tele-exergaming Tablet
- Keywords
- gaming, exer-gaming, telemedicine, inpatient, deconditioning, mobility, rehabilitation, virtual, persons under investigation for COVID, PUI
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-exergaming TabletOther
The Tele-Exergame is a self-administered, tablet-based exercise platform guided by foot-worn sensors. The platform virtually supervises exercise tasks and coaches patients to perform evidence-based foot and ankle exercises designed to improve balance, cognition, and lower extremity vascular health. Foot-worn sensors track body movement in real time, while the tablet provides step-by-step interactive guidance, enabling patients to complete exercises independently without in-person supervision or direct physical contact. The program uses a game-based approach, similar to playing a video game, which increases patient motivation and engagement in the cognitively demanding exercise program. Sessions are performed twice daily, lasting 3 to 10 minutes based on patient ability, for the duration of hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Tele-exergame arm | Experimental | Participants will receive standard of care plus the Tele-Exergame mobility program. The intervention is a self-administered, game-based exercise program in which foot-worn sensors track body movement and a tablet provides step-by-step interactive guidance, enabling participants to complete exercises independently without in-person supervision. At baseline, participants will complete a single 3-minute session of the Tele-Exergame to evaluate the feasibility and acceptability of self-administered exercise using the platform. Participants will then be asked to continue using the Tele-Exergame for the duration of hospitalization, with sessions performed twice daily, lasting 3 to 10 minutes based on patient ability, and a minimum of one session per day for at least three consecutive days. Receives: Other: Tele-exergaming Tablet |
| Convention care or control group | No intervention | Participants will receive standard of care only, including routine in-hospital care and any mobility encouragement provided as part of usual practice. At baseline, participants will complete a single 3-minute session of the Tele-Exergame to evaluate the feasibility and acceptability of self-administered exercise using the platform. Beyond this single baseline session, no Tele-Exergame or sensor-based exercise intervention will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program
Feasibility was assessed using three metrics. Metric 1: Number of participants able to independently complete at least one 3-minute Tele-Exergame session guided by the interactive tablet, assessed in both groups, as both the intervention and control groups performed one 3-minute session at baseline to establish feasibility. Metric 2: Number of participants who dropped out within the first three days of inpatient stay. For the intervention group, dropout was defined as not using the Tele-Exergame on two consecutive days for any reason, withdrawal of consent, unwillingness to continue participation, or any adverse event causing inability to continue exercise (e.g., death, unconsciousness, delirium, or clinical deterioration). For the control group, dropout was defined as self-reported inability to perform any in-hospital exercise, withdrawal of consent, or study dropout. Metric 3: Number of participants with intervention-related adverse events.
Measured: Metric 1: Baseline (during hospitalization). Metric 2: First 3 days of inpatient stay. Metric 3: From enrollment through hospital discharge (an average of 1 week)
Secondary outcomes (2)
Katz Activities of Daily Living Scale
The Katz Index of Independence in Activities of Daily Living assesses functional independence in six basic self-care activities: bathing, dressing, toileting, transferring, continence, and feeding. Total scores range from 0 to 6, with higher scores indicating greater independence and lower scores indicating greater functional dependence. This assessment was completed at 4 weeks post hospital discharge.
Measured: 4 weeks post hospital discharge
Life Space
Life-space mobility was assessed using the Life Space Questionnaire (LSQ), a validated measure of the geographic extent of an individual's movement within the previous three days. The questionnaire evaluates mobility across nine hierarchical spatial levels, ranging from movement within the home to travel outside the region. Total scores in the present study ranged from 9 to 18, with higher scores indicating greater life-space mobility, broader community participation, and higher levels of functional independence. This assessment was completed 30 days post hospital discharge.
Measured: 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start5 Jul 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- COVID-19 patients or PUI (persons under investigation) admitted to the MEDVAMC (n=60), with an anticipated length of stay of at least 3 days will be recruited. Participants will be randomized (n=1:1) to either intervention (IG) or control (CG) groups. Both groups will receive standard of care. IG will additionally receive Tele-Exergame MP therapy. Tele-Exergame sessions will range from 3-10 minutes based on patient ability and completed twice daily. They will complete assessments at baseline and at one-month post-hospital discharge.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Sarvari V Yellapragada, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743401
- Sponsor's protocol ID
- F3731-P
- Other IDs
- 42402
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2021
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04743401
- Acronym / sponsor ID
- F3731-P
- Conditions
- COVID 19, Rehabilitation, Inpatient, Hospitalized
- Keywords
- gaming, exer-gaming, telemedicine, inpatient, deconditioning, mobility, rehabilitation, virtual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Baylor College of Medicine
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 5 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conventional in-hospital mobility programs are challenging to deliver to hospitalized infected patients (e.g., COVID-19) due to infection risk to staff, staffing shortages, and potential exposure of other patients. This study evaluates a tele-exergame mobility program, a self-administered, game-based exercise intervention guided by foot-worn sensors and step-by-step interactive guidance on a tablet. The platform promotes strength, balance, and flexibility while enhancing patient motivation and engagement through cognitively demanding gamified tasks, with remote supervision and no to minimum direct physical contact.
Detailed description
This feasibility randomized controlled trial will recruit 60 COVID-19 patients or persons under investigation admitted to the Michael E. DeBakey VA Medical Center with an anticipated length of stay of at least 3 days.
Participants will be randomized 1:1 to an intervention or control group. Both groups will receive standard of care and will complete a single 3-minute Tele-Exergame session at baseline to evaluate the feasibility and acceptability of self-administered exercise using the platform.
The intervention group will additionally continue the Tele-Exergame mobility program, a self-administered exercise intervention in which foot-worn sensors track body movement and a tablet provides step-by-step interactive guidance, enabling patients to exercise independently without in-person supervision. Sessions will be performed twice daily, lasting 3 to 10 minutes based on patient ability, with a minimum of one session per day for at least three consecutive days during hospitalization. The control group will receive no Tele-Exergame or sensor-based exercise intervention beyond the single baseline session.
Assessments will be completed at baseline, at hospital discharge, and approximately 4 weeks post-discharge via telemedicine or telephone.
Primary Outcome: Feasibility. Feasibility is defined by (1) the ability to independently complete at least one 3-minute Tele-Exergame session (assessed in both groups); (2) exercise dropout within the first three days of inpatient stay in the intervention group, defined as not using the Tele-Exergame on two consecutive days for any reason (only for Intervention group), including withdrawal of consent, unwillingness to continue participation, or any adverse event precluding continued exercise (e.g., death, unconsciousness, or discharge sooner than 3 days after admission); and (3) absence of intervention-related adverse events.
Secondary Outcome: Proof-of-concept effectiveness. Effectiveness is defined by (1) the ability to independently perform instrumental activities of daily living at 4 weeks post hospital discharge and (2) community engagement, defined by life-space mobility.
This contactless mobility program could address limitations of conventional in-hospital mobility programs, enable exploration of digital biomarkers of hospital-acquired deconditioning and cognitive frailty using wearables, and advance remote patient monitoring. Findings may benefit hospitalized Veterans beyond COVID-19, including bedbound patients with limited mobility, by mitigating hospital-acquired complications such as deconditioning, venous thromboembolism, and nosocomial infections, and by accelerating post-hospitalization recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- COVID-19 patients or PUI (persons under investigation) admitted to the MEDVAMC (n=60), with an anticipated length of stay of at least 3 days will be recruited. Participants will be randomized (n=1:1) to either intervention (IG) or control (CG) groups. Both groups will receive standard of care. IG will additionally receive Tele-Exergame MP therapy. Tele-Exergame sessions will range from 3-10 minutes based on patient ability and completed twice daily. They will complete assessments at baseline and at one-month post-hospital discharge.
| Arm | Type | Receives |
|---|---|---|
| Tele-exergame arm | Experimental | Other: Tele-exergaming TabletParticipants will receive standard of care plus the Tele-Exergame mobility program. The intervention is a self-administered, game-based exercise program in which foot-worn sensors track body movement and a tablet provides step-by-step interactive guidance, enabling participants to complete exercises independently without in-person supervision. At baseline, participants will complete a single 3-minute session of the Tele-Exergame to evaluate the feasibility and acceptability of self-administered exercise using the platform. Participants will then be asked to continue using the Tele-Exergame for the duration of hospitalization, with sessions performed twice daily, lasting 3 to 10 minutes based on patient ability, and a minimum of one session per day for at least three consecutive days. |
| Convention care or control group | No intervention | –Participants will receive standard of care only, including routine in-hospital care and any mobility encouragement provided as part of usual practice. At baseline, participants will complete a single 3-minute session of the Tele-Exergame to evaluate the feasibility and acceptability of self-administered exercise using the platform. Beyond this single baseline session, no Tele-Exergame or sensor-based exercise intervention will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants: Men or women Veterans with COVID-19 or PUI or hospitalized patients with duration of admission anticipated to be greater than 72 hours admitted to MEDVAMC.
- Length of stay: Anticipated length of stay at least 3 days.
- Ambulatory. Self-report of being ambulatory with or without an assistive device in the 2 weeks before admission.
Key exclusion criteria (12 listed)
- ICU admission: The investigators will exclude those admitted to ICU at any point in their hospital stay.
- Admission of observation only: These patients will be excluded as length of stay is usually anticipated to be less than 3 days
- Median life expectancy: Those with imminently terminal (death expected in the next 30 days) will be excluded.
- Cognitive impairment: The investigators will exclude those with delirium, dementia, or severe cognitive impairment
- Medical condition: The investigators will exclude those who have any medical diagnosis deemed by the primary physician to be a contraindication to ambulation (i.e.: unstable from pulmonary embolus, unstable angina, severe hemodynamic instability etc.)
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 |
|---|---|---|
| Tele-exergaming TabletThe Tele-Exergame is a self-administered, tablet-based exercise platform guided by foot-worn sensors. The platform virtually supervises exercise tasks and coaches patients to perform evidence-based foot and ankle exercises designed to improve balance, cognition, and lower extremity vascular health. Foot-worn sensors track body movement in real time, while the tablet provides step-by-step interactive guidance, enabling patients to complete exercises independently without in-person supervision or direct physical contact. The program uses a game-based approach, similar to playing a video game, which increases patient motivation and engagement in the cognitively demanding exercise program. Sessions are performed twice daily, lasting 3 to 10 minutes based on patient ability, for the duration of hospitalization | Other | Tele-exergame arm |
Primary outcome
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program
Time frame: Metric 1: Baseline (during hospitalization). Metric 2: First 3 days of inpatient stay. Metric 3: From enrollment through hospital discharge (an average of 1 week)
Feasibility was assessed using three metrics. Metric 1: Number of participants able to independently complete at least one 3-minute Tele-Exergame session guided by the interactive tablet, assessed in both groups, as both the intervention and control groups performed one 3-minute session at baseline to establish feasibility. Metric 2: Number of participants who dropped out within the first three days of inpatient stay. For the intervention group, dropout was defined as not using the Tele-Exergame on two consecutive days for any reason, withdrawal of consent, unwillingness to continue participation, or any adverse event causing inability to continue exercise (e.g., death, unconsciousness, delirium, or clinical deterioration). For the control group, dropout was defined as self-reported inability to perform any in-hospital exercise, withdrawal of consent, or study dropout. Metric 3: Number of participants with intervention-related adverse events.
2 secondary outcomes
Katz Activities of Daily Living Scale
Time frame: 4 weeks post hospital discharge
Life Space
Time frame: 30 days post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sarvari V Yellapragada, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-exergaming Tablet in people with COVID 19 and Rehabilitation, run by VA Office of Research and Development 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 12 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: finished, as of the sponsor's last update on 5 Aug 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?
Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program (time frame: Metric 1: Baseline (during hospitalization). Metric 2: First 3 days of inpatient stay. Metric 3: From enrollment through hospital discharge (an average of 1 week)). 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 5 Aug 2026.