Trial Outcomes & Findings for Feasibility of a Tele-game-based Exercise (Tele-exergame) Program to Prevent Deconditioning in Hospitalized COVID-19 Patients (NCT NCT04743401)

NCT ID: NCT04743401

Last Updated: 2026-08-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

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)

Results posted on

2026-08-05

Participant Flow

54 Veterans admitted to the Michael E. DeBakey VA Medical Center (MEDVAMC) in Houston, Texas were recruited and completed the study. These participants were either admitted due to COVID-19 or classified as Persons Under Investigation (PUI), or they were expected to have a hospital stay of at least three days, in line with our inclusion and exclusion criteria

Participant milestones

Participant milestones
Measure
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.
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
Overall Study
STARTED
27
27
Overall Study
COMPLETED
25
23
Overall Study
NOT COMPLETED
2
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tele-exergame Arm
n=27 Participants
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. Sessions will be performed twice daily, lasting 3 to 10 minutes based on patient ability, for the duration of hospitalization
Convention Care or Control Group
n=27 Participants
Participants will receive standard of care only, including routine in-hospital care and any mobility encouragement provided as part of usual practice. No tele-exergame or sensor-based exercise intervention will be provided.
Total
n=54 Participants
Total of all reporting groups
Age, Continuous
64.7 Years
STANDARD_DEVIATION 12.0 • n=20 Participants
66.6 Years
STANDARD_DEVIATION 11.5 • n=20 Participants
65.6 Years
STANDARD_DEVIATION 11.8 • n=40 Participants
Sex: Female, Male
Female
1 Participants
n=20 Participants
1 Participants
n=20 Participants
2 Participants
n=40 Participants
Sex: Female, Male
Male
26 Participants
n=20 Participants
26 Participants
n=20 Participants
52 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=20 Participants
5 Participants
n=20 Participants
10 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants
n=20 Participants
22 Participants
n=20 Participants
44 Participants
n=40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Asian
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=20 Participants
8 Participants
n=20 Participants
16 Participants
n=40 Participants
Race (NIH/OMB)
White
19 Participants
n=20 Participants
19 Participants
n=20 Participants
38 Participants
n=40 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=20 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Life Space
12.7 score
STANDARD_DEVIATION 4.0 • n=20 Participants
13.5 score
STANDARD_DEVIATION 4.2 • n=20 Participants
13.1 score
STANDARD_DEVIATION 4.1 • n=40 Participants
Katz Activities of Daily Living Scale
5.69 score
STANDARD_DEVIATION 0.74 • n=20 Participants
5.36 score
STANDARD_DEVIATION 1.35 • n=20 Participants
5.53 score
STANDARD_DEVIATION 1.08 • n=40 Participants

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure
Tele-exergame Arm
n=27 Participants
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 day.
Convention Care or Control Group
n=27 Participants
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.
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program
Metric 1: Participants Able to Independently Complete at Least One 3-Minute Tele-Exergame Session
27 Participants
27 Participants
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program
Metric 2: Participants Who Dropped Out Within the First 3 Days of Inpatient Stay
2 Participants
4 Participants
Number of Participants Meeting Feasibility Criteria of the Tele-Exergame Program
Metric 3: Participants With Intervention-Related Adverse Events
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 4 weeks post hospital discharge

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.

Outcome measures

Outcome measures
Measure
Tele-exergame Arm
n=22 Participants
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 day.
Convention Care or Control Group
n=20 Participants
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.
Katz Activities of Daily Living Scale
5.18 score
Standard Deviation 1.14
5.25 score
Standard Deviation 1.07

SECONDARY outcome

Timeframe: 30 days post hospital discharge

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.

Outcome measures

Outcome measures
Measure
Tele-exergame Arm
n=22 Participants
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 day.
Convention Care or Control Group
n=20 Participants
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.
Life Space
11.14 score
Standard Deviation 1.36
11.40 score
Standard Deviation 1.64

Adverse Events

Tele-exergame Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Convention Care or Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarvari Yellapragada

MD Anderson

Phone: 832 207 3053

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place