WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis

Not Applicable

• Conditions: Osteoarthritis; Knee; Obesity

• Registration Number: NCT06946329
• Lead Sponsor: University of Sistan and Baluchestan

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 Timeline

• Study Start: 2024-03-01
• Primary Completion: 2024-09-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-19
• Study First Submitted QC: 2025-04-19
• Last Update Submitted: 2025-04-19
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sport Sciences Department; 🇮🇷 Zahedan, Sistan And Baluchestan, Iran, Islamic Republic of