Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study

Feasibility of Exergame-Based Rehabilitation in Patients With Limited Mobility

1. Study Title:

   Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study

2. 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.

3. 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.

4. 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.

5. 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.

6. Study Duration:

   The study runs from October 2024 to October 2025, during which participants undergo rehabilitation exercises using motion-tracking exergames.

7. 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.

8. 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 Overview

• Status: Completed
• Conditions: Solid Organ Transplant; Bed-ridden Patient; Post Critical Care
• Intervention / Treatment: Device: Rehabilitation

Detailed Description

1. Study Title: Use of an Off-the-Shelf Exergame as an In-Bed Gamified Rehabilitation Intervention for Severely Deconditioned Inpatients: A Feasibility Study

2. 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.

3. Senior Investigator: Dr. Won Kim Co-investigators: Dr. Yong Hoe Koo, Dr. Woo Chul Son Agency: Asan Medical Center, Seoul Study
4. Study Design: A prospective, single-center, feasibility study of approximately 20 participants meeting the inclusion and exclusion criteria.

5. 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.

6. 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.

7. Estimated Duration of Study:

The study will run from October 2024 to October 2025.

8. Study Participants and Methods

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.

   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.

2. 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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervetional; Since study includes single arm, all participants will receive 2 weeks of exergaming rehabilitation intervetion	Device: Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: UNIST (Ulsan National Institute of Science and Technology)

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Critical illness; Exergaming; Intensive care unit-acquired weakness
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: S2024-1735-0010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No