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临床试验/NCT06885008
NCT06885008已完成不适用

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

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
Knee disability

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Gaming

Experimental

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

干预措施: Active video game (Other)

Gaming

Experimental

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

干预措施: Conventional treatment (Other)

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.

干预措施: Aerobic exercise (Other)

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.

干预措施: Conventional treatment (Other)

Control

Experimental

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

干预措施: Conventional treatment (Other)

结局指标

主要结局

Knee disability

时间窗: 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.

Functional capacity

时间窗: 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.

Functional Performance

时间窗: 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.

Balance

时间窗: 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.

次要结局

  • Limb strength(8 weeks)

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan Usgu

Ass. Prof.

Hasan Kalyoncu University

研究点 (1)

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