Trial Outcomes & Findings for Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study (NCT NCT06937463)

Participants were recruited from among post-transplant inpatients at Asan Medical Center, a tertiary university hospital in Seoul, Republic of Korea, between October 2024 and October 2025. The study targeted non-ambulatory adult patients (Functional Ambulation Category ≤ 3) who required critical care following organ transplantation.

Not applicable. All enrolled participants directly proceeded to the baseline evaluation and intervention.

Race and Ethnicity were not collected from any participant.

Feasibility and adherence were assessed by the number of completed and discontinued exercise movements and completed sessions during the intervention period. A session was considered interrupted if terminated before completing the planned exercise set. Completed sessions rate: percentage of 10 planned sessions finished per each participants Outcomes are percentages (0-100); higher values indicate better adherence

Feasibility and adherence were assessed by the number of completed and discontinued exercise movements during the intervention period. An exercise movement was considered discontinued if the participant stopped or was unable to complete the specific repetitions or prescribed movements within a session. Exercise movement completion rate is the percentage of prescribed movements successfully finished per each participant. Outcomes are percentages (0-100); higher values indicate better adherence.

Feasibility will be assessed by measuring the trend of net exercise time during the intervention to evaluate appropriateness of exercise.

Summation score of muscle strength based on MRC scale. Unit of Measure: Sum score (0 to 60, where a higher score indicates better overall muscle strength.)

Measurement of the level of ambulation and assistance required. Unit of Measure: FAC score (0 to 5, where a higher score indicates greater walking independence.)

a 0-10 ordinal scale that captures the highest level of mobility achieved, from passive movements in bed to independent ambulation.

Measurement of grip strength using a dynamometer. A higher value indicates better grip strength.

Assessment of knee extensor strength using a dynamometer. A higher value indicates stronger knee extensor muscles.

The EQ-5D-5L index score is a standardized instrument for measuring generic health-related quality of life. It assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The index score is calculated using the South Korean valuation set (Kim et al., 2016). The scores range from -0.066 to 1, where 1 represents "perfect health," 0 represents "death," and -0.066 represents the worst possible health state. Higher scores indicate a better health-related quality of life.

The EQ-5D-5L VAS is a component of the EQ-5D-5L instrument that provides a quantitative measure of the respondent's overall health as perceived by themselves. The scale ranges from 0 to 100, where 0 represents "the worst imaginable health state" and 100 represents "the best imaginable health state." Higher scores indicate a better perceived health status.

The 5-Time Sit-to-Stand Test is a clinical measure used to evaluate functional lower-extremity muscle strength and balance. Performance is graded on an ordinal scale from 0 to 4 based on the time taken to complete five stands. The scores are defined as follows: 0 = inability to complete within 60 seconds; 1 = \>16.7 seconds; 2 = 13.7-16.69 seconds; 3 = 11.2-13.69 seconds; and 4 = \<11.2 seconds. The total score ranges from 0 to 4. Higher scores represent better functional performance and stronger lower-limb strength. At all assessment points, participants were unable to complete the task within the 60-second limit due to their clinical status, resulting in a score of 0 for all subjects.

The Straight Leg Raise test is used to assess the strength and endurance of the hip flexors and knee extensors. In this study, the performance is graded on a scale of 0 to 3 based on the angle of elevation and the number of repetitions. The grading criteria are: Grade 0 (unable to perform); Grade 1 (less than 30° elevation); Grade 2 (at least 30° elevation with fewer than 10 repetitions); and Grade 3 (at least 30° elevation with 10 or more repetitions). The total score ranges from 0 to 3, where higher scores indicate better lower-limb muscle strength and endurance.

The Bridge test is used to assess the strength and stability of the core and hip extensor muscles. Performance is graded on an ordinal scale from 0 to 3 based on the bridge height achieved and the number of repetitions. The grading criteria are: Grade 0 (unable to perform); Grade 1 (bridge height allowing a flat hand to pass); Grade 2 (bridge height allowing a fist to pass for fewer than 5 repetitions); and Grade 3 (bridge height allowing a fist to pass for 5 or more repetitions). The total score ranges from 0 to 3, where higher scores indicate better core stability and gluteal muscle strength.

The Participant Satisfaction and Motivation subscale is part of a study-specific self-reported satisfaction questionnaire. It evaluates the interest, overall satisfaction, and motivation levels of the participants regarding the exergaming program. This subscale consists of 4 items (Items 1-4). Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). The total score is calculated by summing the scores of the 4 items. The total score ranges from 4 to 20. Higher scores indicate a better outcome, representing higher levels of satisfaction and motivation.

The Convenience and Suitability subscale is part of a study-specific self-reported satisfaction questionnaire. It assesses the ease of use, clarity of instructions, and the ability to perform exercises without major clinical difficulties. This subscale consists of 3 items (Items 5-7). Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). The total score is calculated by summing the scores of the 3 items. The total score ranges from 3 to 15. Higher scores indicate a better outcome, representing better convenience and suitability of the program.

The Perceived Effectiveness subscale is part of a study-specific self-reported satisfaction questionnaire. It evaluates the participant's perception of the program's benefits regarding their confidence, muscle strength, and overall health status. This subscale consists of 4 items (Items 8-11). Each item is rated on a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). The total score is calculated by summing the scores of the 4 items. The total score ranges from 4 to 20. Higher scores indicate a better outcome, representing a higher perceived effectiveness of the program.

Perceived exercise intensity is assessed using a single-item scale within the study-specific satisfaction questionnaire. It captures the participant's subjective rating of exercise difficulty during the intervention sessions. The scale ranges from 1 to 5, where 1 indicates "very easy," 3 indicates "appropriate," and 5 indicates "very difficult". For this clinical population, a score of 3 (appropriate) is considered the ideal outcome.

The exercise heart rate was monitored using an optical armband sensor (Verity Sense, Polar Electro, Kempele, Finland).

This measure represents the physiological intensity of the exercise, calculated as a percentage of the heart rate reserve (HRR). First, HRR was determined as the difference between the estimated maximal heart rate (220 - age) and the resting heart rate. Then, the exercise intensity was calculated using the following formula: %HRR = \[(Exercise HR - Resting HR) / HRR\] x 100. The reported value is the average %HRR recorded during the intervention sessions. The scale ranges from 0% to 100%, where higher percentages indicate a higher intensity of exertion.