- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885008
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- 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
-
-
Gaziantep
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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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Gaming
The gaming group played active video games via Xbox kinect 3 days per week, addition to conventional physiotherapy for 8 weeks.
|
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.
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.
|
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.
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.
|
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
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
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
Investigators
- 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
- 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.
- 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.
- 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.
- 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.
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)
November 1, 2023
Primary Completion (Actual)
May 30, 2024
Study Completion (Actual)
June 26, 2024
Study Registration Dates
First Submitted
March 13, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 19, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/05
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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