NCT06885008

Brief Summary

This randomized controlled trial was conducted by the CONSORT guidelines for non-pharmacological treatments. Participants were randomly assigned to control, gaming, or aerobic groups using the closed-envelope randomization method. All groups received conventional physiotherapy for 8 weeks. In addition, the gaming group played active video games 3 days per week, while the aerobic group engaged in cycling-based aerobic exercise (20 minutes per session) 3 days per week. The control group received only conventional physiotherapy and continued their daily activities. Evaluations were performed by the same assessor at the baseline and after eight weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 13, 2025

Last Update Submit

March 19, 2025

Conditions

Keywords

Knee OsteoarthritisVideo GamesAerobic ExercisePainDisabilitiy

Outcome Measures

Primary Outcomes (4)

  • Knee disability

    The WOMAC index was used to assess functional disability in patients with knee osteoarthritis. It consists of 24 items divided into three subcategories: pain severity, stiffness, and physical function. Each item is scored on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as a percentage, with higher scores indicating increased pain and stiffness and reduced physical function.

    8 weeks

  • Functional capacity

    The 6MWT was used to measure patients' functional capacity. Two cones were placed 30 meters apart, and participants were instructed to walk as quickly as possible without running. The total distance walked in six minutes was recorded in (m) meters.

    8 weeks

  • Functional Performance

    The TUG test was administered to assess dynamic balance, walking speed, and functional performance. Participants were seated in a fixed chair without armrests, with their hips and knees positioned at a 90-degree angle. Upon the "START" command, they were instructed to stand up, walk three meters, turn around a designated cone, and return to the starting position. The total time (seconds) required to complete the task was recorded.

    8 weeks

  • Balance

    The modified Y-Balance test was used to assess dynamic balance. In this test, the maximum distances reached in the Anterior (A), Posteromedial (PM), and Posterolateral (PL) directions were recorded. The assessment was conducted using a specialized platform with Y-shape. Participants were instructed to position the foot being tested at the center of the platform while reaching as far as possible with the opposite foot in the A, PM, and PL directions. Measurements were taken bilaterally, ensuring that the participant's balance was maintained throughout the procedure. The test was repeated three times, and the average distances were recorded in (cm) centimeters.

    8 weeks

Secondary Outcomes (1)

  • Limb strength

    8 weeks

Study Arms (3)

Gaming

EXPERIMENTAL

The gaming group played active video games via Xbox kinect 3 days per week, addition to conventional physiotherapy for 8 weeks.

Other: Active video gameOther: Conventional treatment

Aerobic

EXPERIMENTAL

The aerobic group engaged in cycling-based aerobic exercise (20 minutes per session) 3 days per week addition to conventional physiotherapy for 8 weeks.

Other: Aerobic exerciseOther: Conventional treatment

Control

EXPERIMENTAL

The control group received only conventional physiotherapy and continued their daily activities.

Other: Conventional treatment

Interventions

The participants played the video game using an Xbox 360 Kinect console connected to a 55-inch Full HD television. The video games were planned with the assistance of a physiotherapist, 3 days per week, with 8 repetitions during the first 4 weeks and 12 repetitions during the final 4 weeks. The warm-up and cool-down periods were designed and applicated.

Gaming

Aerobic exercise training was performed on a stationary bike, 3 days per week, for 20 minutes per session. The intensity of the aerobic exercise was determined using the Karvonen method. For the first 4 weeks, the intensity was set at 30-50% of the maximum heart rate (MHR), corresponding to light intensity, and was then increased to 50-70% (moderate intensity) for the following 4 weeks. A pulse oximeter (ChoiceMMed, China) was used to monitor the target heart rate. During both the warm-up and cool-down phases of the aerobic exercise, participants performed hip abduction and adduction, hip-knee flexion, heel raises, and mini squats while standing for 3-5 minutes.

Aerobic

Convetional treatment included Hotpack, Transcutaneous Electrical Nerve Stimulation (TENS), and Ultrasound (US) modalities, were applied to the symptomatic knee(s) for a total duration of 30 minutes. Following this, the exercise program outlined below was performed with 3 sets of 10 repetitions each. The session lasted approximately 45 minutes.

AerobicControlGaming

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants, aged 30-65 years who were diagnosed with unilateral or bilateral osteoarthritis based on the clinical and radiological criteria of the American College of Rheumatology.
  • The severity of osteoarthritis was classified as stage 2-3 according to the Kellgren-Lawrence grading system for gonarthrosis.
  • Participants were required to be able to walk independently for at least 15 meters and to refrain from using non-steroidal anti-inflammatory drugs (NSAIDs) during the study period.

You may not qualify if:

  • A history of lower extremity surgery within the past 6 months,
  • The presence of neurological or systemic diseases,
  • Other inflammatory joint diseases,
  • Getting classic physiotherapy and rehabilitation within the past month,
  • Intra-articular corticosteroid injections within the past 3 months,
  • Severe joint deformities or movement restrictions,
  • Severe visual impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

Şahinbey, Gaziantep, 27300, Turkey (Türkiye)

Location

Related Publications (4)

  • Kong H, Wang XQ, Zhang XA. Exercise for Osteoarthritis: A Literature Review of Pathology and Mechanism. Front Aging Neurosci. 2022 May 3;14:854026. doi: 10.3389/fnagi.2022.854026. eCollection 2022.

    PMID: 35592699BACKGROUND
  • Cicek A, Ozdincler AR, Tarakci E. Interactive video game-based approaches improve mobility and mood in older adults: A nonrandomized, controlled tri̇al. J Bodyw Mov Ther. 2020 Jul;24(3):252-259. doi: 10.1016/j.jbmt.2020.01.005. Epub 2020 Feb 6.

    PMID: 32825997BACKGROUND
  • Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x.

    PMID: 37684597BACKGROUND
  • Lange B, Flynn S, Proffitt R, Chang CY, Rizzo AS. Development of an interactive game-based rehabilitation tool for dynamic balance training. Top Stroke Rehabil. 2010 Sep-Oct;17(5):345-52. doi: 10.1310/tsr1705-345.

    PMID: 21131259BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Serkan Usgu, Ass Prof

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

November 1, 2023

Primary Completion

May 30, 2024

Study Completion

June 26, 2024

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations