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

NCT06946342 | Active Not Recruiting

• 2 other identifiers: 9378-30 - 1 - 20259378
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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). Outcomes include pain intensity (VAS), functional disability (ODI), and health-related quality of life (SF-36).

Conditions

Low Back Pain; Obesity; Sedentary Behavior

Keywords

Hydrotherapy; Exercise Therapy; Middle Aged; Quality of Life; Disability Evaluation

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  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

  Oswestry Disability Index (ODI), Scale Range: 0% (no disability) to 100% (severe disability)

  Baseline, 8 weeks (post-intervention), 3-month follow-up

Secondary Outcomes (2)

• Health-Related Quality of Life (HRQoL)

  Baseline, 8 weeks (post-intervention), 3-month follow-up

• Participant Satisfaction

  8 weeks (post-intervention), 3-month follow-up

Study Arms (2)

"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."

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."

Behavioral: Land-Based Rehabilitation Group"

Interventions

"Aquatic Exercise Group" BEHAVIORAL

"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."

"Aquatic Exercise Group

Land-Based Rehabilitation Group" BEHAVIORAL

"60-minute land-based sessions (3x/week for 8 weeks), including core stabilization, low-impact aerobics, and stretching."

"Land-Based Rehabilitation Group"

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sistan and Baluchestan: lead

Study Sites (1)

Sport Sciences Department

Zahedan, Sistan and Baluchestan, 9816744818, Iran

Location

MeSH Terms

Conditions

Low Back Pain; Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Behavior

Study Officials

• Mohammadreza Rezaeipour, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind (outcome assessors only; participants/instructors unblinded due to intervention nature).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: January 25, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 30, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)