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

• 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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 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.