OsteoarthritisWATERinMOTIONNCT06946329
WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis
A study testing Aquatic Exercise and Land-Based Rehabilitation in people with Osteoarthritis and Knee, run by University of Sistan and Baluchestan at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Osteoarthritis, Knee, Obesity
- What is being tested?
- Aquatic Exercise and Land-Based Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 45-65
- BMI ≥30 kg/m²
- Radiographic knee OA (Kellgren-Lawrence grade 2-3)
- WOMAC pain score ≥25/50
Who cannot join
- Inflammatory arthritis (e.g., rheumatoid)
- Intra-articular injections within 3 months
- Contraindications to aquatic exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Osteoarthritis, Knee, Obesity
- Being tested
- Aquatic Exercise, Land-Based Rehabilitation
- Keywords
- Aquatic Therapy, Exercise Therapy, Quality of Life, Biomarkers, Wearable Electronic Devices
- Medical subject headings
- Osteoarthritis, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExerciseBehavioural
Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises.
Land-Based RehabilitationBehavioural
Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Exercise | Experimental | Supervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises. Receives: Behavioral: Aquatic Exercise |
| Land-Based Rehabilitation | Active comparator | Matched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics. Receives: Behavioral: Land-Based Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Pain Subscale
Change from baseline in WOMAC pain score (0-20 scale).
Measured: Baseline, 8 weeks, 6 months
WOMAC Function Subscale
Change in functional disability (0-68 scale).
Measured: Baseline, 8 weeks, 6 months
Secondary outcomes (3)
SF-36 Quality of Life
Physical/Mental Component Summaries (0-100).
Measured: Baseline, 8 weeks, 6 months
Serum COMP
Change in cartilage oligomeric matrix protein (ng/mL).
Measured: Baseline, 8 weeks
Daily Step Count
Measured via ActiGraph GT9X accelerometer.
Measured: Continuous over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sistan and Baluchestan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammadreza Rezaeipour, University of Sistan and Baluchestan
- Investigators
- Mohammadreza Rezaeipour, MD,PhD, Study director, Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946329
- Sponsor's protocol ID
- 9378-1403
- Acronym
- WATERinMOTION
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concerns (sensitive health data of overweight/obese men). Lack of pre-specified data-sharing plan in ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic and Functional Outcomes of WATERinMOTION Aquatic Therapy in Obese Men With Knee Osteoarthritis: A Randomized Controlled Trial With 6-Month Follow-Up
- ClinicalTrials.gov ID
- NCT06946329
- Acronym / sponsor ID
- WATERinMOTION / 9378-1403
- Conditions
- Osteoarthritis, Knee, Obesity
- Keywords
- Aquatic Therapy, Exercise Therapy, Quality of Life, Biomarkers, Wearable Electronic Devices
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sistan and BaluchestanUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercise | Experimental | Behavioral: Aquatic ExerciseSupervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises. |
| Land-Based Rehabilitation | Active comparator | Behavioral: Land-Based RehabilitationMatched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 45-65
- BMI ≥30 kg/m²
- Radiographic knee OA (Kellgren-Lawrence grade 2-3)
- WOMAC pain score ≥25/50
Key exclusion criteria (3 listed)
- Inflammatory arthritis (e.g., rheumatoid)
- Intra-articular injections within 3 months
- Contraindications to aquatic exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic ExerciseSupervised WATERinMOTION sessions (60 mins, 3x/week) in heated pool. Focus on progressive resistance and mobility exercises. | Behavioural | Aquatic Exercise |
| Land-Based RehabilitationMatched frequency/duration land-based program emphasizing core stabilization and low-impact aerobics. | Behavioural | Land-Based Rehabilitation |
Primary outcome
WOMAC Pain Subscale
Time frame: Baseline, 8 weeks, 6 months
Change from baseline in WOMAC pain score (0-20 scale).
WOMAC Function Subscale
Time frame: Baseline, 8 weeks, 6 months
Change in functional disability (0-68 scale).
3 secondary outcomes
SF-36 Quality of Life
Time frame: Baseline, 8 weeks, 6 months
Serum COMP
Time frame: Baseline, 8 weeks
Daily Step Count
Time frame: Continuous over 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No. Privacy concerns (sensitive health data of overweight/obese men). Lack of pre-specified data-sharing plan in ethics approval.
Related trials for Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammadreza Rezaeipour, MD,PhD study director
Assoc.Prof.Dr. of University of Sistan and Baluchestan, Zahedan, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercise and Land-Based Rehabilitation in people with Osteoarthritis and Knee, run by University of Sistan and Baluchestan at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Subscale (time frame: Baseline, 8 weeks, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.