Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04743401
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
VA Office of Research and Development

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


Condition or disease Intervention/treatment Phase
COVID 19 Rehabilitation Other: Tele-exergaming Tablet Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients
Actual Study Start Date : July 5, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tele-exergame arm
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.
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.


No Intervention: Convention care or control group
Standard of care only



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Katz Activities of Daily Living Scale [ Time Frame: The time frame will be from enrollment to 4 weeks post discharge ]
    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.


Other Outcome Measures:
  1. Measuring cognition (MOCA) scale [ Time Frame: The time frame will be from enrollment to 4 weeks post discharge ]
    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 .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants: Men or women Veterans with COVID-19 or PUI 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743401


Contacts
Layout table for location contacts
Contact: Sarvari V Yellapragada, MD (713) 794-7303 sarvari.yellapragada@va.gov
Contact: Ilse P Torres Ruiz, MD (713) 798-8714 ilse.torresruiz@va.gov

Locations
Layout table for location information
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Paula A Kinsel    713-794-7939    Paula.Kinsel@va.gov   
Contact: Christine M Eriks    (713) 791-1414 ext 26714    Christine.Eriks@va.gov   
Principal Investigator: Sarvari V Yellapragada, MD         
Sponsors and Collaborators
VA Office of Research and Development
Baylor College of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Sarvari V Yellapragada, MD Michael E. DeBakey VA Medical Center, Houston, TX
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04743401    
Other Study ID Numbers: F3731-P
42402 ( Other Identifier: Baylor IRB )
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
gaming
exer-gaming
telemedicine
inpatient
deconditioning
mobility
rehabilitation
virtual
persons under investigation for COVID
PUI
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases