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.
COMPLETED
NA
54 participants
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)
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
| 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
| 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
| 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 dischargeThe 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
| 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 dischargeLife-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
| 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
Convention Care or Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place