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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquatic Exercise | Experimental | Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises. |
|
| Land-Based Rehabilitation | Active Comparator | Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquatic Exercise | Behavioral | Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises. |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain Subscale | Change from baseline in WOMAC pain score (0-20 scale). | Baseline, 8 weeks, 6 months |
| WOMAC Function Subscale | Change in functional disability (0-68 scale). | Baseline, 8 weeks, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 Quality of Life | Physical/Mental Component Summaries (0-100). | Baseline, 8 weeks, 6 months |
| Serum COMP | Change in cartilage oligomeric matrix protein (ng/mL). |
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Inclusion Criteria:
Exclusion Criteria:
Males aged 45-65
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| Name | Affiliation | Role |
|---|---|---|
| Mohammadreza Rezaeipour, MD,PhD | Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport Sciences Department | Zahedan | Sistan and Baluchestan | 9816744818 | Iran |
Privacy concerns (sensitive health data of overweight/obese men). Lack of pre-specified data-sharing plan in ethics approval.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000088543 | Aquatic Therapy |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Parallel Assignment
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Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
| Land-Based Rehabilitation | Behavioral | Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics. |
|
| Baseline, 8 weeks |
| Daily Step Count | Measured via ActiGraph GT9X accelerometer. | Continuous over 8 weeks |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |