NCT04743401

Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Conventional face-to-face in-hospital mobility program (MP) is challenging for COVID-19 patients because of its associated risk of infection to hospital staff, staffing shortages as well as indirect risk of exposure to other hospitalized patients. Exergames are digital or web-based games that use body movement to promote physical activity and generally involve strength, balance, and flexibility exercises. The tele-exergame MP, developed by the team, uses a remotely supervised and game-based approach, which helps to increase patient motivation and engagement in a cognitively demanding exercise program. Objectives: To demonstrate the feasibility, acceptability, and effectiveness of the Tele-Exergame mobility program in COVID-19 or PUI (persons under investigation), during hospitalization and examine post-hospitalization outcomes. Research Design: Prospective randomized

Detailed description

KEY RESEARCH AIMS: Aim 1: To examine feasibility of Tele-exergame. The investigators will evaluate feasibility by documenting missing exercise sessions, exercise dropout, and acceptability questionnaire. Aim 2: To examine proof of concept effectiveness to reduce deconditioning. The investigators will assess deconditioning (using wearables) and patient reported mental health assessed at baseline at discharge. Aim 3: Examine proof of concept effectiveness to accelerate recovery post hospital discharge. Approximately 4 weeks after discharge, patients will be contacted by telemedicine or telephone and requested to self-report on the Veterans mental health and the Veterans mobility. METHODS: 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. SCIENTIFIC MERIT: The proposed contact-less mobility program could address the limitations of conventional in-hospital mobility program and advance the field of in-hospital exercise program. The investigators will use innovative wearables to exploring potential digital biomarkers of hospital-acquired illness including cognitive-frailty. illness. This study will advance the field of remote patient monitoring BENEFIT TO VETERANS: Its implementation not only for mobility program for hospitalized COVID-19 Veteran patients but also to deliver personalized exercise for non-COVID-19 Veteran patients with limited mobility including in bedbound and hospitalized Veteran patients Mobilizing hospitalized Veteran patients could mitigate hospital acquired complications like deconditioning, VTE and nosocomial infections and accelerate recovery post hospitalization

Conditions

• COVID 19
• Rehabilitation
• Inpatient
• Hospitalized

Interventions

Type	Name	Description
OTHER	Tele-exergaming Tablet	The Tele-Exergame platform virtually supervises exercise tasks and coaches patients to perform evidence-based foot and ankle exercises that have been designed to improve balance, cognition, and lower extremity vascular health. The exergame program uses a game-based approach, similar to playing a video game, which helps to increase patient motivation and engagement in the cognitively demanding exercise program.

Timeline

• Start date: 2021-07-05
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-08
• Last updated: 2024-01-09

Locations

1 site across 1 country: United States