Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030-4211
- Michael E. DeBakey VA Medical Center, Houston, TX
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Katz Activities of Daily Living Scale
Time Frame: 4 weeks post hospital discharge
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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.
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4 weeks post hospital discharge
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Life Space
Time Frame: 30 days post hospital discharge
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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.
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30 days post hospital discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measuring cognition (MOCA) scale
Time Frame: The time frame will be from enrollment to 4 weeks post discharge
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The MOCA ( Montreal Cognitive Assessment Scale) will be used to measure cognition at baseline, within the first week of inpatient stay and at 4 weeks .
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The time frame will be from enrollment to 4 weeks post discharge
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarvari V Yellapragada, MD, Michael E. DeBakey VA Medical Center, Houston, TX
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F3731-P
- 42402 (Other Identifier: Baylor IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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