Chronic Low Back Pain (Non-specific, Uncomplicated)AquaLand-CLBPNCT06874881
Aquatic and Land Exercises for Chronic Low Back Pain
A study testing Aquatic Exercises and Land Exercises in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (Non-specific, Uncomplicated)
- What is being tested?
- Aquatic Exercises and Land Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2025to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. Leonard building, The University of Edinburgh
Edinburgh, EH8 8AQ
About this study
Official title: 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?
- Being tested
- Aquatic Exercises, Land Exercises
- Keywords
- Chronic low back pain, Aquatic therapy, Hydrotherapy, Water-based exercise, Exercise intervention, Land Exercise, Quality of life, Rehabilitation research, Functional Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExercisesOther
Also called Aquatic Physical Therapy, Hydrotherapy, Water-Based Exercises, Aquatic Therapy
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.
Land ExercisesOther
Also called Land-Based Exercise Therapy, Physiotherapy-Based Exercise, Musculoskeletal Rehabilitation Program, Therapeutic Exercise Routine
The land-based exercise intervention mirrors the aquatic exercise protocol regarding exercise type, duration, frequency, and progression but is performed on land.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Land Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Quality of Life is assessed by the Short-Form Health Survey 36, a validated questionnaire measuring the eight physical and mental health domains.
Measured: 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
The Pittsburgh Sleep Quality Index measures the sleep quality, its scores measured from 0-21, with higher scores indicating poor sleep quality.
Measured: 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)
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.
Measured: 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
The Y balance test measures dynamic balance by measuring stability while reaching in three directions: anterior, posteromedial, and posterolateral.
Measured: 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
The active knee extension test is a clinical measure of the hamstring flexibility.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start6 Mar 2025
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (Non-specific, Uncomplicated)Studies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Parallel-group, Randomized Controlled Trial (RCT) design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874881
- Sponsor's protocol ID
- NARS01072024
- Acronym
- AquaLand-CLBP
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aquatic and Land Exercises on Chronic Nonspecific Low Back Pain: A Randomised Study
- ClinicalTrials.gov ID
- NCT06874881
- Acronym / sponsor ID
- AquaLand-CLBP / NARS01072024
- Keywords
- Chronic low back pain, Aquatic therapy, Hydrotherapy, Water-based exercise, Exercise intervention, Land Exercise, Quality of life, Rehabilitation research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 13 Mar 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, Randomized Controlled Trial (RCT) design
| Arm | Type | Receives |
|---|---|---|
| Aquatic Exercise Group | Experimental | Other: Aquatic ExercisesThe 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. |
| Land Exercise Group | Active comparator | Other: Land ExercisesThe land exercise group will follow the same structured protocol as the aquatic exercise group regarding duration, frequency, and intensity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 ExercisesAlso: Aquatic Physical Therapy, Hydrotherapy, Water-Based Exercises, Aquatic TherapyThe 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 | Aquatic Exercise Group |
| Land ExercisesAlso: Land-Based Exercise Therapy, Physiotherapy-Based Exercise, Musculoskeletal Rehabilitation Program, Therapeutic Exercise RoutineThe land-based exercise intervention mirrors the aquatic exercise protocol regarding exercise type, duration, frequency, and progression but is performed on land. | Other | Land Exercise Group |
Primary outcome
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).
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).
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).
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.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Exercises and Land Exercises in people with Chronic Low Back Pain (Non-specific, Uncomplicated), run by University of Edinburgh at 1 site in United Kingdom.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 2 Dec 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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).). 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 2 Dec 2025.