Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| UNIST (Ulsan National Institute of Science and Technology) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Study Title:
Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study
Purpose of the Study:
This study aims to evaluate the feasibility and safety of an exergame-based rehabilitation program using motion recognition for bedridden inpatients. The primary objective is to determine whether digital rehabilitation can serve as a substantial adjunct to augment total rehabilitation volume.
Study Participants:
The study involves 28 adult inpatients confined to bed. Participants will use the Nintendo Ring Fit™, which provides a motion-tracking gamified rehabilitation program, with an exercise plan personalized to each patient's physical condition.
Research Methodology:
Exercise Protocol: Participants will engage in a personalized exercise program for two weeks using the Nintendo Ring Fit. Each session lasts approximately 30 minutes, occurs once daily, and is supervised by a therapist. Exercise intensity and type are tailored to the patient's physical condition to ensure safety.
Safety and Efficacy Monitoring: Participants' physical function (e.g., strength, mobility) is tracked throughout the study. Patients are continuously monitored for any discomfort or adverse events during exercise sessions. Motor responses are closely observed to ensure utmost safety.
Study Duration:
The study runs from October 2024 to October 2025, during which participants undergo rehabilitation exercises using motion-tracking exergames.
Expected Results:
The study is expected to demonstrate that digital rehabilitation programs are a feasible and safe adjunct treatment option for bedridden inpatients. Furthermore, the findings will contribute to improving in-hospital rehabilitation practices and promoting physical recovery.
Safety Considerations:
All exercises in this study are designed with safety as the highest priority, with intensity strictly maintained at a very low to low level. If patients experience discomfort or adverse events during a session, exercise is immediately paused, and necessary medical actions are taken. All sessions are conducted under the direct supervision of a healthcare professional.
Study Title: Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study
Objective:
This study aims to evaluate the feasibility and safety of an individually prescribed in-bed exergaming rehabilitation program using Nintendo Ring Fit Adventure™ (NFA) for severely deconditioned inpatients. The study will analyze the intervention's feasibility, safety profile, and concurrent changes in physical function and patient satisfaction.
Senior Investigator: Dr. Won Kim Co-investigators: Dr. Yong Hoe Koo, Dr. Woo Chul Son Agency: Asan Medical Center, Seoul Study
Study Design: A prospective, single-center, feasibility study of approximately 20 participants meeting the inclusion and exclusion criteria.
Background of the Study Advances in acute and critical care medicine have improved survival rates; however, many patients experience profound functional decline, such as Intensive Care Unit-Acquired Weakness (ICU-AW) and severe deconditioning. This behavioral limitation implies several risk factors, including a higher risk of falls, hospital-acquired infections, and a significantly reduced quality of life. Even after hospital discharge, many patients fail to regain their premorbid physical function.
To address these issues, early rehabilitation and mobilization are strongly advocated. Previous studies have demonstrated that early mobilization, ranging from passive range of motion to active transfers, can shorten ICU stays and improve functional recovery. However, delivering sufficient rehabilitation doses to profoundly weak, non-ambulatory inpatients is often limited by systemic constraints, such as staffing shortages and patient fatigue.
By supplementing these conventional therapy limitations, this study explores the feasibility of technology-assisted rehabilitation using a commercially available exergame (Nintendo Ring Fit Adventure™). This study aims to quantitatively evaluate the intervention's feasibility, review its safety, and assess patient compliance and satisfaction in a high-acuity clinical setting.
Research Objectives:
To evaluate the feasibility and safety of implementing a commercial exergame-based in-bed rehabilitation program for severely deconditioned post-transplant inpatients, and to observe its effects on physical function and user satisfaction.
Estimated Duration of Study:
The study will run from October 2024 to October 2025.
8. Study Participants and Methods
Study Participants.
Inclusion criteria:
Organ transplant recipients. Aged 18 years or older who have provided written informed consent. Patients who required critical care. Patients with restricted mobility, defined as an FAC score of 3 or less (unable to ambulate independently).
Exclusion criteria Inability to follow instructions due to cognitive impairment or sedation. Hemodynamic instability precluding rehabilitation. Severe musculoskeletal limitations (e.g., unstable fractures, recent amputations) preventing exercise participation.
Significant sensory impairments (e.g., severe hearing or visual loss) hindering interaction with the exergaming system.
Target Sample Size and Rationale:
Given the nature of this feasibility study and the potential for clinical deterioration or early discharge in this high-acuity population, we aim to enroll approximately 28 participants to ensure an adequate number of completed cases for final evaluation.
Research Method The intervention utilizes the NFA system to provide motion-tracking exergames. Based on the patient's daily clinical status, a certified physical therapist will select up to 10 activities from a predefined in-bed exercise library. The intervention comprises 10 sessions, aimed to be completed within a 2-week period. Each session will take approximately 30 minutes. Baseline function, session completion rates, movement adherence, and adverse events will be closely monitored and recorded. Outcome measures including muscle strength, functional measures, patient reported outcome such as health related quality of life will be collected at the baseline, mid-point and end of the study
9. Statistical Analysis Principles and Methods: Statistical analyses will be performed using SPSS and R software. Statistical significance is set at p < 0.05.Patient demographics and adherence rates will be described using descriptive statistics.The Friedman test will be used to analyze continuous dependent variables measured across multiple time points (e.g., functional scores before, during, and after the intervention). Post hoc pairwise comparisons will be conducted using the Wilcoxon signed-rank test with Bonferroni correction.
10. Criteria for Withdrawal of Participants: Participants may be withdrawn from the study under the following conditions:The participant or legal guardian requests withdrawal. Hospital discharge or transfer to another facility. Clinical deterioration precluding safe continuation. The principal investigator or ethics committee determines that discontinuation is appropriate.
11. Anticipated Side Effects and Safety: Potential side effects include transient fatigue, mild muscle discomfort (e.g., upper extremity pain), and minor hemodynamic fluctuations. However, because the intervention involves very-light to light-intensity in-bed exercises, severe adverse events are considered highly unlikely. The risk of falling is virtually eliminated due to the bed-bound nature of the protocol.
12. Early Termination Criteria: The overall study may be terminated early under the following conditions:Unforeseen, unacceptable risks or severe adverse events are identified.The Institutional Review Board (IRB) or affiliated institution mandates the halt of the trial.
13. Ethical Considerations: This study will be conducted in strict compliance with ethical guidelines approved by the IRB of Asan Medical Center (IRB No. 2024-1159). Written informed consent will be obtained from all participants or their legal representatives after fully explaining the purpose, procedures, and potential risks.
14. Measures for Protecting Participant Privacy: All personal data will be kept strictly confidential. Data will be anonymized, securely stored, and accessible only to the principal investigator and authorized co-investigators. Any video or photographic data collected for motion verification will be encrypted and shared only with designated collaborating institutions under stringent privacy protocols.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervetional | Experimental | Since study includes single arm, all participants will receive 2 weeks of exergaming rehabilitation intervetion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Device | Unambulatory patients after critical care will receive 2 weeks of exergaming rehabilitation(Nintendo Ring Fit Adventure™) in addition to usual physical therapy in bed setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Session Completion Rate | 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 | Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks) |
| Exercise Movement Completion Rate | 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. | Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Net Exercise Time | Feasibility will be assessed by measuring the trend of net exercise time during the intervention to evaluate appropriateness of exercise. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Medical Research Council Sum Score (MRC-SS) |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength Test | Measurement of grip strength using a dynamometer. A higher value indicates better grip strength. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Knee Extensor Test |
1) Study Participants
Inclusion Criteria:
Organ transplant recipients. Aged 18 years or older who have provided written informed consent. Patients who required critical care. Patients with restricted mobility, defined as an FAC score of 3 or less (unable to ambulate independently).
Exclusion Criteria:
Inability to follow instructions due to cognitive impairment or sedation. Hemodynamic instability precluding rehabilitation. Severe musculoskeletal limitations (e.g., unstable fractures, recent amputations) preventing exercise participation.
Significant sensory impairments (e.g., severe hearing or visual loss) hindering interaction with the exergaming system.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Seoul | 05505 | South Korea |
All individual patient data (IPD) used in this study will be handled in compliance with domestic privacy protection laws and relevant regulations. The privacy of study participants will be strictly safeguarded, and their personal information will not be used for purposes other than the study. When sharing data, only de-identified data that has been approved by the researchers after adequate request will be provided, and privacy protection and security will be prioritized throughout the process.
Not provided
Not provided
Not provided
Not provided
Not applicable. All enrolled participants directly proceeded to the baseline evaluation and intervention.
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 provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: In-Bed Exergaming (Nintendo Ring Fit Adventure) | Participants received an individually prescribed in-bed exergaming program using Nintendo Ring Fit Adventure™ (NFA) in addition to usual physical therapy. The intervention consisted of 10 sessions (approximately 30 minutes each) delivered over a 2-week period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 14, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.) |
| Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Functional Ambulatory Category (FAC) | 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.) | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| ICU Mobility Scale | a 0-10 ordinal scale that captures the highest level of mobility achieved, from passive movements in bed to independent ambulation. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
Assessment of knee extensor strength using a dynamometer. A higher value indicates stronger knee extensor muscles. |
| Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| EuroQol 5-Dimension 5-level(EQ-5D-5L) Index Value | 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. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| EQ-5D-5L VAS | 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. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| 5-Time Sit-to-Stand Test | 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. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Straight Leg Raise Test | 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. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Bridge Test | 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. | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
| Participant Satisfaction and Motivation Subscale | 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. | Week 2 (end of intervention after completion of 10 sessions) |
| Convenience and Suitability Subscale | 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. | Week 2 (end of intervention after completion of 10 sessions) |
| Perceived Effectiveness Subscale | 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. | Week 2 (end of intervention after completion of 10 sessions) |
| Perceived Exercise Intensity Score | 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. | Week 2 (end of intervention after completion of 10 sessions) |
| Exercise Heart Rate | The exercise heart rate was monitored using an optical armband sensor (Verity Sense, Polar Electro, Kempele, Finland). | From enrollment to end of 10 intervention sessions, up to 2 weeks |
| Exercise Intensity | 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. | From enrollment to end of 10 intervention sessions, up to 2 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: In-Bed Exergaming (Nintendo Ring Fit Adventure) | Participants received an individually prescribed in-bed exergaming program using Nintendo Ring Fit Adventure™ (NFA) in addition to usual physical therapy. The intervention consisted of 10 sessions (approximately 30 minutes each) delivered over a 2-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Organ Transplant Type | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of Mechanical Ventilation(MV) | The minimum possible value is 0, with no predefined maximum limit. Lower values represent a better clinical outcome (i.e., a shorter duration of ventilator dependence). | Mean | Standard Deviation | days |
| ||||||||||||||||
| Length of Intensive Care Unit(ICU) stay | The total duration of time a participant spent in the Intensive Care Unit (ICU), measured in days. The minimum possible value is 0, with no predefined maximum limit. Lower values represent a better clinical outcome | Mean | Standard Deviation | days |
| ||||||||||||||||
| Acute Physiology And Chronic Health Evaluation(APACHE) IV score at ICU admission | APACHE (Acute Physiology and Chronic Health Evaluation) IV is a severity-of-disease classification system for ICU patients. The total score ranges from 0 to 286. It is calculated by summing points from various physiological and clinical variables. Higher scores represent a greater severity of illness and a higher risk of hospital mortality. | Mean | Standard Deviation | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Session Completion Rate | 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 | Posted | Median | Inter-Quartile Range | percentage of planned sessions | Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Net Exercise Time | Feasibility will be assessed by measuring the trend of net exercise time during the intervention to evaluate appropriateness of exercise. | Posted | Median | Inter-Quartile Range | seconds | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Medical Research Council Sum Score (MRC-SS) | 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.) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Functional Ambulatory Category (FAC) | 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.) | Posted | Median | Inter-Quartile Range | raw score | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Hand Grip Strength Test | Measurement of grip strength using a dynamometer. A higher value indicates better grip strength. | Posted | Median | Inter-Quartile Range | Force (kg) | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Knee Extensor Test | Assessment of knee extensor strength using a dynamometer. A higher value indicates stronger knee extensor muscles. | Posted | Median | Inter-Quartile Range | Force (kg) | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | EuroQol 5-Dimension 5-level(EQ-5D-5L) Index Value | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | EQ-5D-5L VAS | 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. | Posted | Mean | Inter-Quartile Range | scores on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 5-Time Sit-to-Stand Test | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Straight Leg Raise Test | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Bridge Test | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Participant Satisfaction and Motivation Subscale | 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. | Posted | Mean | Standard Deviation | scores on a scale | Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | ICU Mobility Scale | a 0-10 ordinal scale that captures the highest level of mobility achieved, from passive movements in bed to independent ambulation. | Posted | Median | Inter-Quartile Range | raw score | Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Convenience and Suitability Subscale | 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. | Posted | Mean | Standard Deviation | scores on a scale | Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Perceived Effectiveness Subscale | 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. | Posted | Mean | Standard Deviation | scores on a scale | Week 2 (end of intervention after completion of 10 sessions) |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Perceived Exercise Intensity Score | 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. | Posted | Count of Participants | Participants | Week 2 (end of intervention after completion of 10 sessions) |
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exercise Heart Rate | The exercise heart rate was monitored using an optical armband sensor (Verity Sense, Polar Electro, Kempele, Finland). | Posted | Median | Inter-Quartile Range | beats per minute | From enrollment to end of 10 intervention sessions, up to 2 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Exercise Intensity | 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. | Posted | Median | Inter-Quartile Range | percentage of heart rate reservoir(%) | From enrollment to end of 10 intervention sessions, up to 2 weeks |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Exercise Movement Completion Rate | 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. | Posted | Median | Inter-Quartile Range | percentage of prescribed movements | Baseline (at enrollment) and end of intervention (after completion of 10 sessions, up to 2 weeks) |
|
|
From enrollment to end of 10 intervention sessions
Adverse events were collected through non-systematic assessment, relying on spontaneous self-reporting by participants and routine clinical observation by medical staff. Monitoring for adverse events, such as hemodynamic instability, severe fatigue, or pain, was conducted continuously during and immediately after each individually prescribed, in-bed exergaming rehabilitation session using Nintendo Ring Fit Adventure.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: In-Bed Exergaming (Nintendo Ring Fit Adventure) | Participants received an individually prescribed in-bed exergaming program using Nintendo Ring Fit Adventure™ (NFA) in addition to usual physical therapy. The intervention consisted of 10 sessions (approximately 30 minutes each) delivered over a 2-week period. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
This study has several limitations. As a single-arm feasibility study without a control group, the definitive clinical efficacy of the intervention cannot be determined. Additionally, the small sample size (n=20) limits statistical power. Finally, because the study focused on a specific population (post-transplant inpatients with severe deconditioning), the findings may not be fully generalizable to other patient groups.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Won Kim, MD, PhD | Asan Medical Center | 02-3010-3769 | duocl79@gmail.com |
| May 13, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|