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

NCT06937463 | Completed Results

• 1 other identifier: S2024-1735-0010
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Title:
2. 2.Purpose of the Study:
3. 3.Study Participants:
4. 4.Research Methodology:
5. 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. 6.Study Duration:
7. 7.Expected Results:
8. 8.Safety Considerations:

Conditions

Bed-ridden Patient; Solid Organ Transplant; Post Critical Care

Keywords

Exergaming; Rehabilitation; Critical illness; Intensive care unit-acquired weakness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Net Exercise Time

  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)

  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)

  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

  Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions)

Other Outcomes (13)

• Hand Grip Strength Test

  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

  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

  Baseline (at enrollment), Week 1 (midpoint after 1 week of intervention), and Week 2 (end of intervention after completion of 10 sessions)

Study Arms (1)

Intervetional

EXPERIMENTAL

Since study includes single arm, all participants will receive 2 weeks of exergaming rehabilitation intervetion

Device: Rehabilitation

Interventions

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.

Intervetional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• UNIST (Ulsan National Institute of Science and Technology): collaborator

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

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.

Results Point of Contact

• Title: Won Kim, MD, PhD
• Organization: Asan Medical Center

duocl79@gmail.com

02-3010-3769

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 22, 2025
• Study Start: October 16, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: June 9, 2026
• Results First Posted: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)