- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06874881
Aquatic and Land Exercises for Chronic Low Back Pain (AquaLand-CLBP)
November 28, 2025 updated by: University of Edinburgh
Effectiveness of Aquatic and Land Exercises on Chronic Nonspecific Low Back Pain: A Randomised Study
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?
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
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-
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Edinburgh, United Kingdom, EH8 8AQ
- St. Leonard building, The University of Edinburgh
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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
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aquatic Exercise Group
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.
|
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.
Other Names:
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Active Comparator: Land Exercise Group
The land exercise group will follow the same structured protocol as the aquatic exercise group regarding duration, frequency, and intensity.
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The land-based exercise intervention mirrors the aquatic exercise protocol regarding exercise type, duration, frequency, and progression but is performed on land.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 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).
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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).
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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).
|
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Functional Disability
Time Frame: 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).
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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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life
Time Frame: 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).
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Quality of Life is assessed by the Short-Form Health Survey 36, a validated questionnaire measuring the eight physical and mental health domains.
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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).
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Sleep Quality
Time Frame: 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).
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The Pittsburgh Sleep Quality Index measures the sleep quality, its scores measured from 0-21, with higher scores indicating poor sleep quality.
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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).
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|
Kinesiophobia (Fear of Movement-Related to Pain)
Time Frame: 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).
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Kinesiophobia is measured with the Tampa Scale of Kinesiophobia, a 17-item questionnaire designed to measure the fear associated with the chronic pain and movement.
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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).
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Dynamic Balace Performance
Time Frame: 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).
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The Y balance test measures dynamic balance by measuring stability while reaching in three directions: anterior, posteromedial, and posterolateral.
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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).
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Hamstring Flexibility
Time Frame: 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).
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The active knee extension test is a clinical measure of the hamstring flexibility.
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 6, 2025
Primary Completion (Actual)
November 28, 2025
Study Completion (Actual)
November 28, 2025
Study Registration Dates
First Submitted
March 7, 2025
First Submitted That Met QC Criteria
March 7, 2025
First Posted (Actual)
March 13, 2025
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 28, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NARS01072024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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