Low Back PainWATERinMOTIONNCT06946342
WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life
A study testing "Aquatic Exercise Group" and Land-Based Rehabilitation Group" in people with Low Back Pain and Obesity, run by University of Sistan and Baluchestan at 1 site in Iran.
Trial summary
This randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Obesity, Sedentary Behavior
- What is being tested?
- "Aquatic Exercise Group" and Land-Based Rehabilitation Group"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- 25 Jan 2025to 30 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 45-65, BMI ≥25 kg/m².
- Sedentary (<150 min/week moderate activity).
- Chronic LBP (≥3 months, VAS ≥4).
Who cannot join
- Contraindications to exercise (e.g., severe cardiovascular disease).
- Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Efficacy of the WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life in Sedentary Overweight and Obese Middle-Aged Women: A Randomized Controlled Trial"
This randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).
Read the detailed description
Participants (aged 45-65, BMI ≥25 kg/m², chronic LBP ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). Both groups completed three 60-minute sessions/week for 8 weeks. Assessments occurred at baseline, post-intervention, and 3-month follow-up. Primary outcomes: VAS and ODI; secondary outcomes: SF-36 and satisfaction.
- Conditions
- Low Back Pain, Obesity, Sedentary Behavior
- Being tested
- "Aquatic Exercise Group", Land-Based Rehabilitation Group"
- Keywords
- Hydrotherapy, Exercise Therapy, Middle Aged, Quality of Life, Disability Evaluation
- Medical subject headings
- Low Back Pain, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Aquatic Exercise Group"Behavioural
"Structured WATERinMOTION aquatic exercise program (3x/week for 8 weeks) in a heated pool (30-32°C), including warm-up, aerobic conditioning, resistance training with water equipment (e.g., dumbbells, noodles), and cool-down. Sessions are group-based and led by certified instructors."
Land-Based Rehabilitation Group"Behavioural
"60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching."
| Study group | Role | What they receive |
|---|---|---|
| "Aquatic Exercise Group | Experimental | "60-minute WATERinMOTION sessions (3x/week for 8 weeks) in a heated pool (30-32°C), including aerobic, strength, and flexibility exercises." Receives: Behavioral: "Aquatic Exercise Group" |
| "Land-Based Rehabilitation Group" | Active comparator | "60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching." Receives: Behavioral: Land-Based Rehabilitation Group" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual Analog Scale (VAS), Scale Range: 0 (no pain) to 10 (worst pain imaginable),
Measured: Baseline, 8 weeks (post-intervention), 3-month follow-up
Functional Disability
Oswestry Disability Index (ODI), Scale Range: 0% (no disability) to 100% (severe disability)
Measured: Baseline, 8 weeks (post-intervention), 3-month follow-up
Secondary outcomes (2)
Health-Related Quality of Life (HRQoL)
Measure: 36-Item Short Form Survey (SF-36)
Measured: Baseline, 8 weeks (post-intervention), 3-month follow-up
Participant Satisfaction
Measure: 5-point Likert Scale, Scale Range: 1 (very dissatisfied) to 5 (very satisfied)
Measured: 8 weeks (post-intervention), 3-month follow-up
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 start25 Jan 2025
- Primary completion1 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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
- This is a two-arm, randomized, single-blind, parallel-group trial comparing the efficacy of two distinct exercise interventions: Experimental Arm: Structured aquatic exercise program (WATERinMOTION). Active Comparator Arm: Land-based rehabilitation program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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
- NCT06946342
- Sponsor's protocol ID
- 9378-30 - 1 - 2025
- Other IDs
- 9378
- 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 women/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
- "Efficacy of the WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life in Sedentary Overweight and Obese Middle-Aged Women: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT06946342
- Acronym / sponsor ID
- WATERinMOTION / 9378-30 - 1 - 2025
- Conditions
- Low Back Pain, Obesity, Sedentary Behavior
- Keywords
- Hydrotherapy, Exercise Therapy, Middle Aged, Quality of Life, Disability Evaluation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Sistan and BaluchestanUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 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 randomized controlled trial compares the efficacy of an 8-week WATERinMOTION aquatic exercise program versus land-based rehabilitation for reducing low-back pain (LBP) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).
Detailed description
Participants (aged 45-65, BMI ≥25 kg/m², chronic LBP ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). Both groups completed three 60-minute sessions/week for 8 weeks. Assessments occurred at baseline, post-intervention, and 3-month follow-up. Primary outcomes: VAS and ODI; secondary outcomes: SF-36 and satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized, single-blind, parallel-group trial comparing the efficacy of two distinct exercise interventions: Experimental Arm: Structured aquatic exercise program (WATERinMOTION). Active Comparator Arm: Land-based rehabilitation program.
| Arm | Type | Receives |
|---|---|---|
| "Aquatic Exercise Group | Experimental | Behavioral: "Aquatic Exercise Group""60-minute WATERinMOTION sessions (3x/week for 8 weeks) in a heated pool (30-32°C), including aerobic, strength, and flexibility exercises." |
| "Land-Based Rehabilitation Group" | Active comparator | Behavioral: Land-Based Rehabilitation Group""60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching." |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 45-65, BMI ≥25 kg/m².
- Sedentary (<150 min/week moderate activity).
- Chronic LBP (≥3 months, VAS ≥4).
Key exclusion criteria (2 listed)
- Contraindications to exercise (e.g., severe cardiovascular disease).
- Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).
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 Exercise Group""Structured WATERinMOTION aquatic exercise program (3x/week for 8 weeks) in a heated pool (30-32°C), including warm-up, aerobic conditioning, resistance training with water equipment (e.g., dumbbells, noodles), and cool-down. Sessions are group-based and led by certified instructors." | Behavioural | "Aquatic Exercise Group |
| Land-Based Rehabilitation Group""60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching." | Behavioural | "Land-Based Rehabilitation Group" |
Primary outcome
Pain Intensity
Time frame: Baseline, 8 weeks (post-intervention), 3-month follow-up
Visual Analog Scale (VAS), Scale Range: 0 (no pain) to 10 (worst pain imaginable),
Functional Disability
Time frame: Baseline, 8 weeks (post-intervention), 3-month follow-up
Oswestry Disability Index (ODI), Scale Range: 0% (no disability) to 100% (severe disability)
2 secondary outcomes
Health-Related Quality of Life (HRQoL)
Time frame: Baseline, 8 weeks (post-intervention), 3-month follow-up
Participant Satisfaction
Time frame: 8 weeks (post-intervention), 3-month follow-up
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 women/men). Lack of pre-specified data-sharing plan in ethics approval.
Related trials for Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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. This study is not recruiting at the moment.
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 Group" and Land-Based Rehabilitation Group" in people with Low Back Pain and Obesity, 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 3 inclusion and 2 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: under way, not looking for participants, 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?
Pain Intensity (time frame: Baseline, 8 weeks (post-intervention), 3-month follow-up). 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.