WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis (WATERinMOTION)

April 19, 2025 updated by: Mohammadreza Rezaeipour, University of Sistan and Baluchestan

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Sistan And Baluchestan
      • Zahedan, Sistan And Baluchestan, Iran, Islamic Republic of, 9816744818
        • Sport Sciences Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aquatic Exercise
Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.
Behavioral: Aquatic Exercise
Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.
Active Comparator: Land-Based Rehabilitation
Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.
Behavioral: Land-Based Rehabilitation
Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Pain Subscale
Time Frame: Baseline, 8 weeks, 6 months
Change from baseline in WOMAC pain score (0-20 scale).
Baseline, 8 weeks, 6 months
WOMAC Function Subscale
Time Frame: Baseline, 8 weeks, 6 months
Change in functional disability (0-68 scale).
Baseline, 8 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 Quality of Life
Time Frame: Baseline, 8 weeks, 6 months
Physical/Mental Component Summaries (0-100).
Baseline, 8 weeks, 6 months
Serum COMP
Time Frame: Baseline, 8 weeks
Change in cartilage oligomeric matrix protein (ng/mL).
Baseline, 8 weeks
Daily Step Count
Time Frame: Continuous over 8 weeks
Measured via ActiGraph GT9X accelerometer.
Continuous over 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sistan and Baluchestan

Investigators

  • Study Director: Mohammadreza Rezaeipour, MD,PhD, Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 19, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9378-1403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Privacy concerns (sensitive health data of overweight/obese men). Lack of pre-specified data-sharing plan in ethics approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe