Chronic Low-back Pain (cLBP)NCT07732595
Combined and Aquatic Exercise in Chronic Low Back Pain
A study testing Aquatic-exercise Program, Land-based Exercise Program and Home-based Exercise Program in people with Chronic Low-back Pain (cLBP), run by University of Beira Interior at 1 site in Portugal.
Trial summary
The goal of this randomized clinical trial is to evaluate the effects of a combined aquatic- and land-based exercise program, as well as an aquatic-exercise program, compared with a control group receiving home-based exercise, on pain, disability, and functional capacity in adults with CLBP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- What is being tested?
- Aquatic-exercise Program, Land-based Exercise Program and Home-based Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all genders;
- aged over 18 years;
- Chronic Low Back Pain lasting three months or longer and with an intensity of 3 or higher on the Visual Analogue Scale at rest.
Who cannot join
- Individuals who refuse to participate or do not provide informed consent;
- Pain radiating to the lower limb;
- Recent pregnancy or childbirth (less than 8 weeks ago);
- Ongoing physical therapy treatments;
- Severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention;
- History of spinal surgery;
- Inflammatory, infectious, or malignant spinal diseases;
- Psychiatric disorders that may affect adherence and symptom assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
University of Beira Interior
Covilha, Castelo Branco District, 6201-001
Joana Borges, MSc, +351964928447, joanaccborges24@hotmail.com
Joana Borges, MSc
About this study
Official title: Effects of Combined-exercise and Aquatic-exercise on Pain, Disability and Functional Capacity in Patients With Chronic Low Back Pain
The goal of this randomized clinical trial is to evaluate the effects of a combined aquatic- and land-based exercise program, as well as an aquatic-exercise program, compared with a control group receiving home-based exercise, on pain, disability, and functional capacity in adults with CLBP. Secondary objectives include examining the effects on fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility. The main question it aims to answer is: "Which type of exercise program is most effective at improving pain, disability, functional capacity, fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility in adults with chronic low back pain?".
Participants will perform an aquatic-based exercise program (aquatic group), a combined aquatic and land-based exercise program (aquatic and land group), or a land-based exercise program (home group).
Researchers will compare groups to find any differences in pain, disability, functional capacity, kinesiophobia, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility.
- Conditions
- Chronic Low-back Pain (cLBP)
- Being tested
- Aquatic-exercise Program, Land-based Exercise Program, Home-based Exercise Program
- Keywords
- Back Pain, Disability, Exercise, Aquatic Therapy, Physical Capacity
- Medical subject headings
- Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic-exercise ProgramOther
This intervention will consist of an aquatic-exercise program, performed in shallow water (120-150 cm deep) at a temperature of 32-34 °C, and supervised by a physiotherapist with over two years of experience in aquatic-based exercise and Ai Chi method.
The aquatic-exercise sessions, will consist of a 5-minute warm-up phase, a 30-40-minute training phase, and a 10-15-minute relaxation/cool-down phase, adapted from Ai Chi exercise positions. The Ai Chi method consists of 19 katas (movements) that incorporate deep breathing, coordinated upper and lower limb actions, trunk control, and slow, continuous motion. In this study, only 10 of these 19 katas will be included in the aquatic-exercise protocol.
Land-based Exercise ProgramOther
This program will include specific land-based exercises, supervised by a physiotherapist with more than two years of experience in therapeutic exercise. The land-based exercise program, will be divided into three components: core stability exercises (15-20 minutes), trunk and lower limb stretching exercises (10-15 minutes), and relaxation/coordination exercises adapted from the Ai Chi method (10-15 minutes).
Home-based Exercise ProgramOther
This exercise program will consist of a home-based exercise program. Each session will last 20-30 minutes and will be performed individually at home without professional supervision. The home-based exercise program will include core stability exercises that progress from the supine to the quadruped position. It will mirror the land-based exercise program and is adapted from a previous unsupervised home-based protocol.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic and Land Group | Experimental | This arm will include 24 exercise sessions (three non-consecutive sessions per week), conducted over an 8-week period. 16 sessions of the aquatic-exercise program and 8 sessions of the land-based exercise program. Receives: Other: Aquatic-exercise Program; Other: Land-based Exercise Program |
| Aquatic Group | Experimental | This arm will comprise 24 sessions of the aquatic-exercise program (three non-consecutive sessions per week), conducted over an 8-week period. Receives: Other: Aquatic-exercise Program |
| Home Group | Active comparator | This arm will include 24 sessions of the home-based exercise program (three non-consecutive sessions per week) over an 8-week period. Receives: Other: Home-based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Pain intensity will be assessed with the Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Measured: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Oswestry Disability Index - version 2.0
Disability due to low back pain will be assessed with the Oswestry Disability Index (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Measured: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Short Physical Performance Battery
Lower-limb functional capacity (balance, gait speed, chair stands) will be assessed with the Short Physical Performance Battery, a simple tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests. Each component is scored (0-4), yielding a composite score (0-12), with higher scores indicating better performance.
Measured: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Secondary outcomes (5)
Tampa Scale of Kinesiophobia-13
Fear of movement will be assessed with the Tampa Scale of Kinesiophobia-13 (Minimum: 13; Maximum 52). Higher values correspond to worse outcome.
Measured: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Hospital Anxiety and Depression Scale
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (Minimum: 0; Maximum 21). Higher values correspond to worse outcome.
Measured: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Fixed Handheld Dynamometry for Assessing Quadriceps Strength
Quadriceps muscle (both sides) maximum voluntary isometric contraction will be assessed with Fixed Handheld Dynamometry with participants seated and the knee positioned at approximately 90° of flexion.
Measured: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Hand-Grip Dynamometry
Maximum isometric strength of the hand and forearm muscles (both sides) will be assessed with Hand-Grip Dynamometry with participants seated with the elbow flexed at 90° and the forearm in a neutral position.
Measured: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Modified-Modified Schober Test
Lumbar spine range of motion will be assessed with the Modified-Modified Schober Test.
Measured: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
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 (cLBP)Studies of the same condition, open and under way.
- 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
- Participants will be randomly allocated to three groups in a 1:1:1 allocation ratio.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Beira Interior
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Leiria, Instituto Politécnico de Castelo Branco
- Responsible party
- Principal investigator, Joana Catarina Carvalho Borges, University of Beira Interior
- Investigators
- Pedro Duarte-Mendes, PhD, Study director, Instituto Politécnico de Castelo BrancoHenrique Neiva, PhD, Study director, University of Beira InteriorDiogo Monteiro, PhD, Study director, Instituto Politécnico de Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732595
- Sponsor's protocol ID
- CE-UBI-Pj-2026-064
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined-exercise and Aquatic-exercise on Pain, Disability and Functional Capacity in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07732595
- Acronym / sponsor ID
- CE-UBI-Pj-2026-064
- Conditions
- Chronic Low-back Pain (cLBP)
- Keywords
- Back Pain, Disability, Exercise, Aquatic Therapy, Physical Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Beira InteriorUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Leiria, Instituto Politécnico de Castelo Branco
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
The goal of this randomized clinical trial is to evaluate the effects of a combined aquatic- and land-based exercise program, as well as an aquatic-exercise program, compared with a control group receiving home-based exercise, on pain, disability, and functional capacity in adults with CLBP. Secondary objectives include examining the effects on fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility. The main question it aims to answer is: "Which type of exercise program is most effective at improving pain, disability, functional capacity, fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility in adults with chronic low back pain?".
Participants will perform an aquatic-based exercise program (aquatic group), a combined aquatic and land-based exercise program (aquatic and land group), or a land-based exercise program (home group).
Researchers will compare groups to find any differences in pain, disability, functional capacity, kinesiophobia, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated to three groups in a 1:1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Aquatic and Land Group | Experimental | Other: Aquatic-exercise Program, Other: Land-based Exercise ProgramThis arm will include 24 exercise sessions (three non-consecutive sessions per week), conducted over an 8-week period. 16 sessions of the aquatic-exercise program and 8 sessions of the land-based exercise program. |
| Aquatic Group | Experimental | Other: Aquatic-exercise ProgramThis arm will comprise 24 sessions of the aquatic-exercise program (three non-consecutive sessions per week), conducted over an 8-week period. |
| Home Group | Active comparator | Other: Home-based Exercise ProgramThis arm will include 24 sessions of the home-based exercise program (three non-consecutive sessions per week) over an 8-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all genders;
- aged over 18 years;
- Chronic Low Back Pain lasting three months or longer and with an intensity of 3 or higher on the Visual Analogue Scale at rest.
Key exclusion criteria (8 listed)
- Individuals who refuse to participate or do not provide informed consent;
- Pain radiating to the lower limb;
- Recent pregnancy or childbirth (less than 8 weeks ago);
- Ongoing physical therapy treatments;
- Severe rheumatological, neurological, neoplastic, cardiovascular diseases or other conditions that could prevent full participation in the intervention;
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-exercise ProgramThis intervention will consist of an aquatic-exercise program, performed in shallow water (120-150 cm deep) at a temperature of 32-34 °C, and supervised by a physiotherapist with over two years of experience in aquatic-based exercise and Ai Chi method. The aquatic-exercise sessions, will consist of a 5-minute warm-up phase, a 30-40-minute training phase, and a 10-15-minute relaxation/cool-down phase, adapted from Ai Chi exercise positions. The Ai Chi method consists of 19 katas (movements) that incorporate deep breathing, coordinated upper and lower limb actions, trunk control, and slow, continuous motion. In this study, only 10 of these 19 katas will be included in the aquatic-exercise protocol. | Other | Aquatic Group, Aquatic and Land Group |
| Land-based Exercise ProgramThis program will include specific land-based exercises, supervised by a physiotherapist with more than two years of experience in therapeutic exercise. The land-based exercise program, will be divided into three components: core stability exercises (15-20 minutes), trunk and lower limb stretching exercises (10-15 minutes), and relaxation/coordination exercises adapted from the Ai Chi method (10-15 minutes). | Other | Aquatic and Land Group |
| Home-based Exercise ProgramThis exercise program will consist of a home-based exercise program. Each session will last 20-30 minutes and will be performed individually at home without professional supervision. The home-based exercise program will include core stability exercises that progress from the supine to the quadruped position. It will mirror the land-based exercise program and is adapted from a previous unsupervised home-based protocol. | Other | Home Group |
Primary outcome
Visual Analogue Scale
Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Pain intensity will be assessed with the Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Oswestry Disability Index - version 2.0
Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Disability due to low back pain will be assessed with the Oswestry Disability Index (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Short Physical Performance Battery
Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Lower-limb functional capacity (balance, gait speed, chair stands) will be assessed with the Short Physical Performance Battery, a simple tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests. Each component is scored (0-4), yielding a composite score (0-12), with higher scores indicating better performance.
5 secondary outcomes
Tampa Scale of Kinesiophobia-13
Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Hospital Anxiety and Depression Scale
Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Fixed Handheld Dynamometry for Assessing Quadriceps Strength
Time frame: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Hand-Grip Dynamometry
Time frame: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Modified-Modified Schober Test
Time frame: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- 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.
Pedro Duarte-Mendes, PhD study director
Instituto Politécnico de Castelo Branco
Henrique Neiva, PhD study director
University of Beira Interior
Diogo Monteiro, PhD study director
Instituto Politécnico de Leiria
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-exercise Program, Land-based Exercise Program and Home-based Exercise Program in people with Chronic Low-back Pain (cLBP), run by University of Beira Interior at 1 site in Portugal.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Jul 2026. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joana Borges, MSc (+351964928447, joanaccborges24@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).). The study lists 3 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 30 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.