WATERinMOTION Aquatic Exercise Program Compared to Land-Based Rehabilitation on Low-Back Pain Relief and Quality of Life (WATERinMOTION)

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

"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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

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

Yes

Description

Inclusion Criteria:

  • Women aged 45-65, BMI ≥25 kg/m².
  • Sedentary (<150 min/week moderate activity).
  • Chronic LBP (≥3 months, VAS ≥4).

Exclusion Criteria:

  • Contraindications to exercise (e.g., severe cardiovascular disease).
  • Spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).

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 Group
"60-minute WATERinMOTION sessions (3x/week for 8 weeks) in a heated pool (30-32°C), including aerobic, strength, and flexibility exercises."
Behavioral: "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."
Active Comparator: "Land-Based Rehabilitation Group"
"60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching."
Behavioral: Land-Based Rehabilitation Group"
"60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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),
Baseline, 8 weeks (post-intervention), 3-month follow-up
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)
Baseline, 8 weeks (post-intervention), 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life (HRQoL)
Time Frame: Baseline, 8 weeks (post-intervention), 3-month follow-up
Measure: 36-Item Short Form Survey (SF-36)
Baseline, 8 weeks (post-intervention), 3-month follow-up
Participant Satisfaction
Time Frame: 8 weeks (post-intervention), 3-month follow-up
Measure: 5-point Likert Scale, Scale Range: 1 (very dissatisfied) to 5 (very satisfied)
8 weeks (post-intervention), 3-month follow-up

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)

January 25, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 30, 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

  • 9378-30 - 1 - 2025
  • 9378 (Ferdows Shafa)

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 women/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.

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