WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis

NCT ID: NCT06946329

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-05-01

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Knee Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).

Study Groups

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Aquatic Exercise

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

Group Type EXPERIMENTAL

Aquatic Exercise

Intervention Type BEHAVIORAL

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

Land-Based Rehabilitation

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

Group Type ACTIVE_COMPARATOR

Land-Based Rehabilitation

Intervention Type BEHAVIORAL

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

Interventions

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Aquatic Exercise

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

Intervention Type BEHAVIORAL

Land-Based Rehabilitation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sistan and Baluchestan

OTHER

Sponsor Role lead

Responsible Party

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Mohammadreza Rezaeipour

Assoc.Prof.Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammadreza Rezaeipour, MD,PhD

Role: STUDY_DIRECTOR

Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran

Locations

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Sport Sciences Department

Zahedan, Sistan and Baluchestan, Iran

Site Status

Countries

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Iran

Other Identifiers

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9378-1403

Identifier Type: -

Identifier Source: org_study_id

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