Osteoarthritis, Knee, Obesity
Conditions
Keywords
Aquatic Therapy, Exercise Therapy, Quality of Life, Biomarkers, Wearable Electronic Devices
Brief summary
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.
Detailed description
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.
Interventions
Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.
Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.
Sponsors
Study design
Masking description
Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
Intervention model description
Parallel Assignment
Eligibility
Inclusion criteria
* Males aged 45-65 * BMI ≥30 kg/m² * Radiographic knee OA (Kellgren-Lawrence grade 2-3) * WOMAC pain score ≥25/50
Exclusion criteria
* Inflammatory arthritis (e.g., rheumatoid) * Intra-articular injections within 3 months * Contraindications to aquatic exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Pain Subscale | Baseline, 8 weeks, 6 months | Change from baseline in WOMAC pain score (0-20 scale). |
| WOMAC Function Subscale | Baseline, 8 weeks, 6 months | Change in functional disability (0-68 scale). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Quality of Life | Baseline, 8 weeks, 6 months | Physical/Mental Component Summaries (0-100). |
| Serum COMP | Baseline, 8 weeks | Change in cartilage oligomeric matrix protein (ng/mL). |
| Daily Step Count | Continuous over 8 weeks | Measured via ActiGraph GT9X accelerometer. |
Countries
Iran