Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Exercise dropout rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 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.
Arms & Interventions
Tele-exergame arm
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.
Intervention: Tele-exergaming Tablet (Other)
Convention care or control group
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.
Outcomes
Primary Outcomes
Exercise dropout rate
Time Frame: The time frame will be from enrollment to within the first week of inpatient stay
The investigators will evaluate feasibility of Tele-Exergame objectively by documenting the daily missed exercise session and exercise dropout within the first week of inpatient stay.
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.
Secondary Outcomes
- Katz Activities of Daily Living Scale(The time frame will be from enrollment to 4 weeks post discharge)
- Katz Activities of Daily Living Scale(4 weeks post hospital discharge)
- Life Space(30 days post hospital discharge)