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Enrolling by invitationNCT06946329WATERinMOTIONUpdated Apr 27, 2025

WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis

An interventional study of Aquatic Exercise and Land-Based Rehabilitation in Osteoarthritis, Knee and Obesity, sponsored by University of Sistan and Baluchestan. Enrolling by invitation at 1 site in Iran, Islamic Republic of. Open to male participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-27.

Sponsored by University of Sistan and Baluchestan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Knee
  • Obesity

Keywords

  • Aquatic Therapy
  • Exercise Therapy
  • Quality of Life
  • Biomarkers
  • Wearable Electronic Devices
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Sistan and Baluchestan is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Inflammatory arthritis (e.g., rheumatoid)
  • Intra-articular injections within 3 months
  • Contraindications to aquatic exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Aquatic Exercise

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

    Behavioral: Aquatic Exercise

  • Active comparator
    Land-Based Rehabilitation

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

    Behavioral: Land-Based Rehabilitation

Interventions

  • BehavioralAquatic Exercise

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

  • BehavioralLand-Based Rehabilitation

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

06

What researchers measure

Primary outcomes

  1. WOMAC Pain Subscale

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

    Time frame: Baseline, 8 weeks, 6 months

  2. WOMAC Function Subscale

    Change in functional disability (0-68 scale).

    Time frame: Baseline, 8 weeks, 6 months

Secondary outcomes

  1. SF-36 Quality of Life

    Physical/Mental Component Summaries (0-100).

    Time frame: Baseline, 8 weeks, 6 months

  2. Serum COMP

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

    Time frame: Baseline, 8 weeks

  3. Daily Step Count

    Measured via ActiGraph GT9X accelerometer.

    Time frame: Continuous over 8 weeks

07

Study locations

1 site
  • Sport Sciences Department
    Zahedan, Sistan And Baluchestan 9816744818, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No — Privacy concerns (sensitive health data of overweight/obese men). Lack of pre-specified data-sharing plan in ethics approval.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06946329
Lead sponsor
University of Sistan and Baluchestan
Responsible party
Mohammadreza Rezaeipour (Assoc.Prof.Dr., University of Sistan and Baluchestan) — Principal investigator
First posted
Apr 27, 2025
Start date
Mar 1, 2024
Primary completion
Sep 30, 2024
Completion
May 1, 2025 (estimated)
Last update
Apr 27, 2025

Study contacts

Mohammadreza Rezaeipour, MD,PhD
study director · Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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