Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
NCT Number: NCT04743401
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030-4211, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clarifying exclusion criteria
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
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.
Time frame: 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.
Time frame: 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.
VA Office of Research and Development
Fed
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06698549
COVID 19, COVID-19
Miami, Florida, United States
View Trial DetailsNCT04418206
COVID 19, COVID-19
Antibes, Alpes Maritimes, France
View Trial DetailsNCT04828668
COVID 19, COVID-19
Novato, California, United States
View Trial DetailsNCT07029048
COVID 19, COVID-19
Astana, Kazakhstan
View Trial Details