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
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
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.
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.
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
Investigator: Paula A Kinsel, MHA MBA
Contact: 713-794-7939
Paula.Kinsel@va.gov
Investigator: Sarvari V Yellapragada, MD
Sarvari V Yellapragada, MD
(713) 794-7303
sarvari.yellapragada@va.gov
Naima S Rodriguez, MA
(832) 288-2017
Naima.Rodriguez@va.gov
Sarvari V Yellapragada, MD, Principal Investigator
Michael E. DeBakey VA Medical Center, Houston, TX