The Effect of Healthy Lifestyle Management Education and Personalized Physical Activity Counseling on Pain, Functionality, Exercise Adherence, and Irisin Level in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 主要终点
- Physical Function
研究概览
简要总结
Knee osteoarthritis is a common condition that causes knee pain, stiffness, and difficulty in daily activities. Physical activity and exercise are recommended as part of the treatment; however, many individuals have difficulty maintaining regular exercise over time.
The purpose of this study is to evaluate the effects of different physical activity intervention approaches on pain, physical function, and exercise adherence in individuals with knee osteoarthritis. Participants will be randomly assigned to one of three groups. One group will receive a physiotherapist-supervised exercise and physical activity program. The second group will follow an individualized home-based physical activity program that they will perform independently after receiving initial instruction. The third group will receive usual care and will serve as the control group.
The intervention period will last six weeks. Participants in the intervention groups will then be followed for an additional six weeks using telephone-based follow-up to monitor adherence and ongoing physical activity. Outcomes related to pain, physical function, physical activity, and adherence to exercise will be assessed at different time points during the study.
The results of this study are expected to improve understanding of how supervised and home-based physical activity programs may contribute to the management of knee osteoarthritis and support the development of effective rehabilitation strategies.
详细描述
Knee osteoarthritis is a common musculoskeletal condition characterized by pain, reduced physical function, and limitations in daily activities. Regular physical activity and exercise are strongly recommended for the management of knee osteoarthritis; however, long-term adherence to exercise programs remains a major challenge for many patients.
The aim of this randomized controlled trial is to investigate the effects of different modes of physical activity intervention, in addition to usual care, on pain, physical function, exercise adherence, and selected cardiometabolic biomarkers in individuals with knee osteoarthritis.
Eligible participants diagnosed with knee osteoarthritis will be randomly allocated into one of three groups. The first group will receive a physiotherapist-supervised intervention, consisting of structured exercise sessions combined with personalized physical activity counseling delivered by a physiotherapist. The second group will receive an individualized home-based intervention, in which participants will perform the prescribed exercise and physical activity program independently at home following initial instruction and guidance. The third group will serve as the control group and will receive usual care only.
The intervention period will last six weeks for both intervention groups. Following the intervention phase, participants in the intervention groups will be followed for an additional six weeks through telephone-based monitoring to support adherence and record ongoing physical activity. Outcome assessments will be conducted at baseline, at the end of the six-week intervention period, and after completion of the follow-up period.
Primary outcomes will include pain intensity and physical function. Secondary outcomes will include exercise adherence, physical activity level, and selected cardiometabolic biomarkers. The results of this study are expected to provide evidence on the comparative effectiveness of supervised versus home-based physical activity interventions for individuals with knee osteoarthritis and to inform clinical practice and rehabilitation strategies.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Diagnosed with knee osteoarthritis according to clinical and/or radiological criteria
- •Ability to walk independently
- •Willingness to participate and provide written informed consen
排除标准
- •History of knee surgery within the last 6 months
- •Inflammatory rheumatic diseases
- •Neurological or cardiovascular conditions limiting physical activity
- •Participation in a structured exercise program within the last 3 months
研究组 & 干预措施
Physiotherapist-Supervised Intervention Group
Participants will receive conventional physiotherapy combined with physiotherapist-supervised lifestyle management education and individualized physical activity counseling for 6 weeks, followed by a 6-week telephone-based follow-up.
干预措施: Physiotherapist-Supervised Intervention (Other)
Home-Based Self-Managed Intervention Group
Participants will receive lifestyle management education and an individualized home-based physical activity program, which they will perform independently without direct physiotherapist supervision.
干预措施: Physiotherapist-Supervised Intervention (Other)
Home-Based Self-Managed Intervention Group
Participants will receive lifestyle management education and an individualized home-based physical activity program, which they will perform independently without direct physiotherapist supervision.
干预措施: Home based self managed (Other)
Control Group
Participants will receive conventional physiotherapy only, as routinely applied in the hospital setting.
干预措施: Control (Other)
结局指标
主要结局
Physical Function
时间窗: Baseline, Week 6, Week 12
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function subscale will be used to assess the physical functional status of the patients. This subscale consists of 17 items. Each item is scored on a Likert scale from 0 to 4 (0 = None, 4 = Extreme). The total score for this subscale ranges from 0 to 68 points, where higher scores indicate worse physical function (greater functional limitation).
Pain Severity
时间窗: Baseline, Week 6, Week 12
Numeric Analog Scale (NAS) Pain intensity will be assessed using the Numerical Rating Scale (NRS). The scale consists of a single item where patients rate their pain on a 11-point scale ranging from 0 to 10. A score of 0 represents "no pain" and a score of 10 represents "the worst possible pain." Higher scores indicate greater pain intensity.
次要结局
- Serum Irisin Level(Baseline, Week 6, Week 12)
- Exercise Adherence Rating Scale(Baseline, Week 6, Week 12)
研究者
Muhammed ARCA
Director
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital