COVID 19, Hospitalized, Inpatient, Rehabilitation
Conditions
Keywords
gaming, exer-gaming, telemedicine, inpatient, deconditioning, mobility, rehabilitation, virtual, persons under investigation for COVID, PUI
Brief 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. 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.
Interventions
OTHERTele-exergaming Tablet
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
Sponsors
VA Office of Research and Development
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Katz Activities of Daily Living Scale | 4 weeks post hospital discharge | 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. |
| Life Space | 30 days post hospital discharge | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarvari V Yellapragada, MD
Michael E. DeBakey VA Medical Center, Houston, TX
Participant flow
Recruitment details
54 Veterans admitted to the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas were recruited and completed the study. These participants were either admitted due to COVID-19 or classified as Persons Under Investigation (PUI), or they were expected to have a hospital stay of at least three days, in line with our inclusion and exclusion criteria
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Katz Activities of Daily Living Scale | 5.53 score STANDARD_DEVIATION 1.08 |
| Life Space | 13.1 score STANDARD_DEVIATION 4.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 2 / 27 |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 |
Outcome results
None listed