AzTrials
AzTrials

Osteoarthritis of KneeNCT06885008

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

A study testing Active video game, Aerobic exercise and Conventional treatment in people with Osteoarthritis of Knee, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Osteoarthritis of Knee
What is being tested?
Active video game, Aerobic exercise and Conventional treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2023to 26 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

    Şahinbey, Gaziantep, 27300

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Being tested
Active video game, Aerobic exercise, Conventional treatment
Keywords
Knee Osteoarthritis, Video Games, Aerobic Exercise, Pain, Disabilitiy
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active video gameOther

    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.

  • Aerobic exerciseOther

    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.

  • Conventional treatmentOther

    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.

Study groups in NCT06885008
Study groupRoleWhat they receive
GamingExperimentalThe gaming group played active video games via Xbox kinect 3 days per week, addition to conventional physiotherapy for 8 weeks.
Receives: Other: Active video game; Other: Conventional treatment
AerobicExperimentalThe aerobic group engaged in cycling-based aerobic exercise (20 minutes per session) 3 days per week addition to conventional physiotherapy for 8 weeks.
Receives: Other: Aerobic exercise; Other: Conventional treatment
ControlExperimentalThe control group received only conventional physiotherapy and continued their daily activities.
Receives: Other: Conventional treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. 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.

    Measured: 8 weeks

Secondary outcomes (1)

  1. Limb strength

    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,

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start1 Nov 2023
  3. Primary completion30 May 2024
  4. Study completion26 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06885008
Sponsor's protocol ID
2024/05
Status last verified
Mar 2025
First submitted
13 Mar 2025
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35592699

  • 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.

    PubMed 32825997

  • 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.

    PubMed 37684597

  • 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.

    PubMed 21131259

Questions about this trial

What is this clinical trial studying?

A study testing Active video game, Aerobic exercise and Conventional treatment in people with Osteoarthritis of Knee, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee disability (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885008, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in