Mechanistic and Functional Outcomes of WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis: A Randomized Controlled Trial With 6-Month Follow-Up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- WOMAC Pain Subscale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Aquatic Exercise
Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.
Intervention: Aquatic Exercise (Behavioral)
Land-Based Rehabilitation
Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.
Intervention: Land-Based Rehabilitation (Behavioral)
Outcomes
Primary Outcomes
WOMAC Pain Subscale
Time Frame: Baseline, 8 weeks, 6 months
Change from baseline in WOMAC pain score (0-20 scale).
WOMAC Function Subscale
Time Frame: Baseline, 8 weeks, 6 months
Change in functional disability (0-68 scale).
Secondary Outcomes
- SF-36 Quality of Life(Baseline, 8 weeks, 6 months)
- Serum COMP(Baseline, 8 weeks)
- Daily Step Count(Continuous over 8 weeks)
Investigators
Mohammadreza Rezaeipour
Assoc.Prof.Dr.
University of Sistan and Baluchestan