Mechanistic and Functional Outcomes of WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis: A Randomized Controlled Trial With 6-Month Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- WOMAC Pain Subscale
研究概览
简要总结
This RCT evaluates whether WATERinMOTION aquatic therapy improves pain, function, and quality of life more effectively than land-based exercise in obese men with knee osteoarthritis (OA). We will assess clinical outcomes (WOMAC), serum biomarkers (COMP, IL-6), and real-world activity (accelerometry) at baseline, 8 weeks, and 6 months.
详细描述
100 participants (BMI ≥30, age 45-65, radiographic knee OA) will be randomized to:
Aquatic group: 24 sessions over 8 weeks (3x/week) in 32°C water, progressing from buoyancy-assisted to resistance exercises.
Land group: Matched duration/intensity land-based rehabilitation. Primary outcomes: WOMAC pain/function. Secondary outcomes: SF-36 quality of life, serum COMP, 6-minute walk test, and accelerometer-measured step count.
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
- Single (Outcomes Assessor)
盲法说明
Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 45-65
- •BMI ≥30 kg/m²
- •Radiographic knee OA (Kellgren-Lawrence grade 2-3)
- •WOMAC pain score ≥25/50
排除标准
- •Inflammatory arthritis (e.g., rheumatoid)
- •Intra-articular injections within 3 months
- •Contraindications to aquatic exercise
结局指标
主要结局
WOMAC Pain Subscale
时间窗: Baseline, 8 weeks, 6 months
Change from baseline in WOMAC pain score (0-20 scale).
WOMAC Function Subscale
时间窗: Baseline, 8 weeks, 6 months
Change in functional disability (0-68 scale).
次要结局
- SF-36 Quality of Life(Baseline, 8 weeks, 6 months)
- Serum COMP(Baseline, 8 weeks)
- Daily Step Count(Continuous over 8 weeks)
研究者
Mohammadreza Rezaeipour
Assoc.Prof.Dr.
University of Sistan and Baluchestan