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Enrolling by Invitation

NCT Number: NCT06946329

WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Arthritis Body Weight Joint Diseases Knee Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sport Sciences Department

Zahedan, Sistan and Baluchestan, 9816744818, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquatic Exercise

Behavioral

Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.

Land-Based Rehabilitation

Behavioral

Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.

Primary outcomes

  1. WOMAC Pain Subscale

    Time frame: Baseline, 8 weeks, 6 months

    Change from baseline in WOMAC pain score (0-20 scale).

  2. WOMAC Function Subscale

    Time frame: Baseline, 8 weeks, 6 months

    Change in functional disability (0-68 scale).

Secondary outcomes

  1. SF-36 Quality of Life

    Time frame: Baseline, 8 weeks, 6 months

    Physical/Mental Component Summaries (0-100).

  2. Serum COMP

    Time frame: Baseline, 8 weeks

    Change in cartilage oligomeric matrix protein (ng/mL).

  3. Daily Step Count

    Time frame: Continuous over 8 weeks

    Measured via ActiGraph GT9X accelerometer.

Sponsors and collaborators

Lead sponsor

University of Sistan and Baluchestan

Other

Registry information

Official study title

Mechanistic and Functional Outcomes of WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis: A Randomized Controlled Trial With 6-Month Follow-Up

Acronym: WATERinMOTION

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 27, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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