Effect of Video-based Game and Aerobic Exercise on Knee Osteoarthritis

March 19, 2025 updated by: Serkan Usgu, Hasan Kalyoncu University

The Effects of Aerobic Exercise and Active Video Games as Adjuncts to Conventional Physiotherapy on Pain, Functional Capacity, and Balance in Knee Osteoarthritis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Gaziantep
      • Şahinbey, Gaziantep, Turkey, 27300
        • Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gaming
The gaming group played active video games via Xbox kinect 3 days per week, addition to conventional physiotherapy for 8 weeks.
Other: Conventional treatment
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.
Other: Active video game
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.
Experimental: Aerobic
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: Conventional treatment
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.
Other: Aerobic exercise
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.
Experimental: Control
The control group received only conventional physiotherapy and continued their daily activities.
Other: Conventional treatment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knee disability
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Limb strength
Time Frame: 8 weeks
The strength of selected lower extremity muscles was measured using a hand-held dynamometer (HHD) (Model-01165, Lafayette Instrument®, Lafayette IN, USA), with results recorded in newtons. Quadriceps, hamstring, gluteus medius muscles strength were measured. Before strength measurements, each participant performed a familiarization trial. Three measurements were taken for each muscle group, and the average value was used for analysis. A 120-second rest period was provided between measurements,
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serkan Usgu, Ass Prof, Hasan Kalyoncu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024/05 (Other Identifier: Atatürk University Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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