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

NCT04743401 | Completed DMC

• 2 other identifiers: F3731-P42402
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

COVID 19; Rehabilitation; Inpatient; Hospitalized

Keywords

gaming; exer-gaming; telemedicine; inpatient; deconditioning; mobility; rehabilitation; virtual; persons under investigation for COVID; PUI

Outcome Measures

Primary Outcomes (1)

• Exercise dropout rate

  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.

  The time frame will be from enrollment to within the first week of inpatient stay

Secondary Outcomes (1)

• Katz Activities of Daily Living Scale

  The time frame will be from enrollment to 4 weeks post discharge

Other Outcomes (1)

• Measuring cognition (MOCA) scale

  The time frame will be from enrollment to 4 weeks post discharge

Study Arms (2)

Tele-exergame arm

EXPERIMENTAL

COVID-19 patients or PUI (persons under investigation) or other inpatients 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.

Other: Tele-exergaming Tablet

Convention care or control group

NO INTERVENTION

Standard of care only

Interventions

Tele-exergaming Tablet OTHER

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.

Tele-exergame arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sarvari V Yellapragada, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 8, 2021
• Study Start: July 5, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)