NCT06874881

Brief Summary

This study aims to learn about the effects of aquatic and land exercises on managing chronic low back pain in adults aged 18-65. The participants engage in a 12-week supervised land and water-based exercise program. The main questions this study aims to answer are:

  • How effective are aquatic exercises on low back pain, functional disability, Kinesiophobia, sleep quality, and overall quality of life?
  • Is aquatic therapy more effective than land exercises for treating LBP or vice versa?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2025

Completed
Last Updated

December 2, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 7, 2025

Last Update Submit

November 28, 2025

Conditions

Keywords

Chronic low back painAquatic therapyHydrotherapyWater-based exerciseExercise interventionLand ExerciseQuality of lifeRehabilitation researchFunctional Disability

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity

    Pain intensity is measured by the Numerical Pain Rating Scale where the participants will report their pain as 0 (no pain) and 10(worst imaginable pain).

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

  • Functional Disability

    Functional disability is assessed by the Roland-Morris Disability Questionnaire, a 24-item self-reported measure evaluating the impact of low back pain on daily activities.

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

Secondary Outcomes (5)

  • Health-Related Quality of Life

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

  • Sleep Quality

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

  • Kinesiophobia (Fear of Movement-Related to Pain)

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

  • Dynamic Balace Performance

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

  • Hamstring Flexibility

    Baseline before the intervention/pre-testing, at the 8th week of the intervention, within a week after the last training session, and three months after the end of the training (Follow-up period).

Study Arms (2)

Aquatic Exercise Group

EXPERIMENTAL

The aquatic exercise session is approximately 45-60 minutes, thrice a week, for twelve weeks, 36 sessions total. They are supervised by an experienced researcher who is a qualified Physiotherapist. The one-hour session generally includes a warm-up, the main exercise session, and a cool-down period. The exercises include balance and agility training, cardio exercises, flexibility, upper and lower limb stretching and strengthening exercises, trunk rotations, etc. Additionally, the group receives back care education involving guidelines and recommendations for adopting good posture, self-management, and active lifestyle advice each week of the intervention. Also, the participants are given a participant education handbook containing all the information and resources about LBP.

Other: Aquatic Exercises

Land Exercise Group

ACTIVE COMPARATOR

The land exercise group will follow the same structured protocol as the aquatic exercise group regarding duration, frequency, and intensity.

Other: Land Exercises

Interventions

The aquatic exercise intervention consists of structured, supervised, water-based exercises designed and delivered by an experienced physiotherapist specifically for individuals with chronic low back pain. Sessions are conducted in a temperature-controlled swimming pool with proper warm-up and cool-down. The intervention follows a progressive intensity approach with easy, medium, and hard approaches.

Also known as: Aquatic Physical Therapy, Hydrotherapy, Water-Based Exercises, Aquatic Therapy, Pool-Based Rehabilitation, Aquatic Physiotherapy, Aquatic Rehabilitation, Therapeutic Water Exercise
Aquatic Exercise Group

The land-based exercise intervention mirrors the aquatic exercise protocol regarding exercise type, duration, frequency, and progression but is performed on land.

Also known as: Land-Based Exercise Therapy, Physiotherapy-Based Exercise, Musculoskeletal Rehabilitation Program, Therapeutic Exercise Routine
Land Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65
  • Both Genders
  • Literate in the English language to understand instructions/ to complete a self-report questionnaire.
  • Having non-specific Chronic low back pain (≥12 weeks)
  • Patient willingness to be a part of any randomly selected treatment groups.

You may not qualify if:

  • Pregnant Females
  • If they had low back pain as the result of diagnosis of severe osteoporosis, spinal bone disorders such as spondylosis and spondylolisthesis, fractures, lumbar spine stenosis, lower limb joint replacement surgery, hip orthosis, ankylosing spondylitis, rheumatoid arthritis, infective or inflammatory disease, compression of the radial nerve, meningitis, arthrosis, lumbar region tumours, Leg length discrepancy, previous back surgery.
  • Uncontrolled hypertension, Severe postural hypotension, any heart disease like Left heart failure or exercise-induced angina. Medical illnesses without a medical managing plan in place, e.g., uncontrolled epilepsy, diabetes mellitus. Neurologic deficit, open wounds, current or recurrent radiation treatment.
  • Patients with severe depression and psychosis
  • People who are already participating in an individually-prescribed exercise programme for LBP.
  • Aquatic exercises /Pool specific:
  • Individuals with hydrophobia/ water-related anxiety, or inability to adapt to an aquatic environment.
  • Allergy to chlorine, Severe limiting airway disease
  • Faecal or urinary incontinence, diarrhoea, and vomiting.
  • Weight more than the emergency evacuation manual handling risk assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Leonard building, The University of Edinburgh

Edinburgh, EH8 8AQ, United Kingdom

Location

MeSH Terms

Interventions

HydrotherapyAquatic Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-group, Randomized Controlled Trial (RCT) design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 13, 2025

Study Start

March 6, 2025

Primary Completion

November 28, 2025

Study Completion

November 28, 2025

Last Updated

December 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations