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

Primary Purpose

COVID 19, Rehabilitation, Inpatient

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-exergaming Tablet
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID 19 focused on measuring gaming, exer-gaming, telemedicine, inpatient, deconditioning, mobility, rehabilitation, virtual, persons under investigation for COVID, PUI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tele-exergame arm

Convention care or control group

Arm Description

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.

Standard of care only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Katz Activities of Daily Living Scale
The investigators will assess deconditioning and patient reported community mobility by the Katz Activities of Daily Living Scale questionnaire at baseline, within the first week of inpatient stay and at 4 weeks.

Full Information

First Posted
January 12, 2021
Last Updated
January 18, 2023
Sponsor
VA Office of Research and Development
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04743401
Brief Title
Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Official Title
Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19, Rehabilitation, Inpatient, Hospitalized
Keywords
gaming, exer-gaming, telemedicine, inpatient, deconditioning, mobility, rehabilitation, virtual, persons under investigation for COVID, PUI

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-exergame arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Convention care or control group
Arm Type
No Intervention
Arm Description
Standard of care only
Intervention Type
Other
Intervention Name(s)
Tele-exergaming Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise dropout rate
Description
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.
Time Frame
The time frame will be from enrollment to within the first week of inpatient stay
Secondary Outcome Measure Information:
Title
Katz Activities of Daily Living Scale
Description
The investigators will assess deconditioning and patient reported community mobility by the Katz Activities of Daily Living Scale questionnaire at baseline, within the first week of inpatient stay and at 4 weeks.
Time Frame
The time frame will be from enrollment to 4 weeks post discharge
Other Pre-specified Outcome Measures:
Title
Measuring cognition (MOCA) scale
Description
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 .
Time Frame
The time frame will be from enrollment to 4 weeks post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarvari V Yellapragada, MD
Phone
(713) 794-7303
Email
sarvari.yellapragada@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Naima S Rodriguez, MA
Phone
(832) 288-2017
Email
Naima.Rodriguez@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarvari V Yellapragada, MD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula A Kinsel, MHA MBA
Phone
713-794-7939
Email
Paula.Kinsel@va.gov
First Name & Middle Initial & Last Name & Degree
Christine M Eriks
Phone
(713) 791-1414
Ext
26714
Email
Christine.Eriks@va.gov
First Name & Middle Initial & Last Name & Degree
Sarvari V Yellapragada, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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