Chronic Low-back Pain (cLBP)NCT06641570

Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain

A study testing Aquatic Exercise Program and Land-based Exercise Program in people with Chronic Low-back Pain (cLBP), run by Instituto Politécnico de Leiria at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 and Land-based Exercise Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 sitePortugal
Study dates: 30 Sep 2024to 30 Apr 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Both gender;
Portuguese nationality;
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.

Portugal1 site

Polytechnic Institute of Leiria
Leiria, Leiria District, 2411-901

Other trials in Portugal

About this study

Official title: Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain: A Randomized Controlled Trial

The goal of this randomized clinical trial] is to study the effect of a combined aquatic and land-based exercise program compared to an aquatic program on pain, functional disability, and quality of life in adults with chronic low back pain. The main question it aims to answer is: "Does a combined aquatic and land-based exercise program improve functional disability and quality of life and reduce pain in adults with chronic low back pain?".

Participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group).

Researchers will compare groups to find any differences in pain, funcional disability and quality of life.

Conditions: Chronic Low-back Pain (cLBP)
Being tested: Aquatic Exercise Program, Land-based Exercise Program
Keywords: Pain, Exercise, Hydrotherapy, Aquatic Therapy, Disability
Medical subject headings: 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 include 16 sessions of an aquatic-exercise program, twice a week, over 8 weeks at a water temperature between 32-34°C. Each session will be conducted in groups of 8 to 12 patients and will last about 45 minutes.
Land-based Exercise ProgramOther
This intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs.

Study groups in NCT06641570
Study group	Role	What they receive
Aquatic Exercise Program + Land-exercise Program	Experimental	This intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs. Core Stability Exercises: These will consist of isometric exercises maintained for 7-8 seconds, 8-12 repetitions, 1 set, with brief rest intervals of 3 seconds between repetitions and 30 seconds to 1 minute between exercises. Exercises will include abdominal hollowing, side bridge (both sides), supine extension bridge, lower limb extension from prone (both sides), and alternate arm and leg raise from quadruped. Stretching Exercises: Participants will perform muscle stretching exercises, holding the maximum stretch for 30 seconds to 1 minute, and returning to the original position, followed by 5 to 10 seconds of rest. Each exercise will be repeated two to three times. Stretches will target the hamstrings, iliopsoas, piriformis, and tensor fasciae latae. Receives: Other: Aquatic Exercise Program; Other: Land-based Exercise Program
Aquatic Exercise Program	Active comparator	This intervention will include 16 sessions of an aquatic-exercise program, twice a week, over 8 weeks at a water temperature between 32-34°C. Each session will be conducted in groups of 8 to 12 patients and will last about 45 minutes. The aquatic exercise sessions will include a warm-up phase: walking forwards, sideways, and backwards; a training phase: active range of motion exercises for the spine, upper and lower limbs; aerobic exercises with jumps and static running at various speeds; muscle strengthening, 8-12 repetitions, 1-2 sets, 8-10 exercises including hip flexion, extension, adduction, and abduction, knee flexion and extension, knee cycling, shoulder flexion, extension, and abduction, elbow flexion, extension, and pronation-supination, squatting, and stretching exercises for the neck, trunk, and limbs; and a relaxation/cool-down phase: including lying supine and low-impact exercises such as slow walking, squatting, and standing. Receives: Other: Aquatic Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain
Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Functional Disability
Quantitive variable evaluated with Oswestry Disability Index - version 2.0. (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks
Quality of life
Quantitive variable evaluated with MOS Short Form Health Survey 36 Item v2. (Minimum: 0; Maximum 100). Higher values correspond to better outcome.
Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (2)

Lumbar spine range of motion
Quantitive variable evaluated with Modified-Modified Schober Test.
Measured: From enrollment to the end of treatment at 8 weeks
Fear of movement or (re)injury
Quantitive variable evaluated with Tampa Scale of Kinesiophobia-13. (Minimum: 13; Maximum 52). Higher values correspond to worse outcome.
Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 202430 Apr 2025

First posted15 Oct 2024
Study start30 Sep 2024
Primary completion31 Mar 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06641570
Sponsor's protocol ID: CE/IPLEIRIA/47/2024
Status last verified: Jan 2025
First submitted: 9 Oct 2024
Last updated: 5 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Borges J, Monteiro D, Silva FM, Jacinto M, Pastilha T, Duarte-Mendes P. Effects of a land and aquatic exercise-based program on pain, mobility and quality of life in patients with chronic low back pain: a study protocol for a randomized controlled trial. PLoS One. 2025 May 20;20(5):e0320858. doi: 10.1371/journal.pone.0320858. eCollection 2025.
PubMed 40392887

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low-back Pain (cLBP) trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients With Chronic Low Back Pain: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06641570
Acronym / sponsor ID: CE/IPLEIRIA/47/2024
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Pain, Exercise, Hydrotherapy, Aquatic Therapy, Disability
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Instituto Politécnico de LeiriaUniversity, hospital or other
Collaborators: Instituto Politécnico de Castelo Branco
Study start: 30 Sep 2024 (actual)
Primary completion: 31 Mar 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 15 Oct 2024 (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.

Participants will perform an aquatic exercise program (control group) or a combined aquatic and land-based exercise program (experimental group).

Researchers will compare groups to find any differences in pain, funcional disability and quality of life.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aquatic Exercise Program + Land-exercise Program	Experimental	Other: Aquatic Exercise Program, Other: Land-based Exercise ProgramThis intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs. Core Stability Exercises: These will consist of isometric exercises maintained for 7-8 seconds, 8-12 repetitions, 1 set, with brief rest intervals of 3 seconds between repetitions and 30 seconds to 1 minute between exercises. Exercises will include abdominal hollowing, side bridge (both sides), supine extension bridge, lower limb extension from prone (both sides), and alternate arm and leg raise from quadruped. Stretching Exercises: Participants will perform muscle stretching exercises, holding the maximum stretch for 30 seconds to 1 minute, and returning to the original position, followed by 5 to 10 seconds of rest. Each exercise will be repeated two to three times. Stretches will target the hamstrings, iliopsoas, piriformis, and tensor fasciae latae.
Aquatic Exercise Program	Active comparator	Other: Aquatic Exercise ProgramThis intervention will include 16 sessions of an aquatic-exercise program, twice a week, over 8 weeks at a water temperature between 32-34°C. Each session will be conducted in groups of 8 to 12 patients and will last about 45 minutes. The aquatic exercise sessions will include a warm-up phase: walking forwards, sideways, and backwards; a training phase: active range of motion exercises for the spine, upper and lower limbs; aerobic exercises with jumps and static running at various speeds; muscle strengthening, 8-12 repetitions, 1-2 sets, 8-10 exercises including hip flexion, extension, adduction, and abduction, knee flexion and extension, knee cycling, shoulder flexion, extension, and abduction, elbow flexion, extension, and pronation-supination, squatting, and stretching exercises for the neck, trunk, and limbs; and a relaxation/cool-down phase: including lying supine and low-impact exercises such as slow walking, squatting, and standing.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Both gender;
Portuguese nationality;
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 include 16 sessions of an aquatic-exercise program, twice a week, over 8 weeks at a water temperature between 32-34°C. Each session will be conducted in groups of 8 to 12 patients and will last about 45 minutes.	Other	Aquatic Exercise Program, Aquatic Exercise Program + Land-exercise Program
Land-based Exercise ProgramThis intervention will include 8 sessions in 8 weeks, once a week. Each session will last between 25 to 35 minutes and will be divided into two components: core stability exercises and stretching of the trunk and lower limbs.	Other	Aquatic Exercise Program + Land-exercise Program

Primary outcome

Pain
Time frame: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Functional Disability
Time frame: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with Oswestry Disability Index - version 2.0. (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Quality of life
Time frame: From enrollment to the end of treatment at 8 weeks
Quantitive variable evaluated with MOS Short Form Health Survey 36 Item v2. (Minimum: 0; Maximum 100). Higher values correspond to better outcome.

2 secondary outcomes

Lumbar spine range of motion
Time frame: From enrollment to the end of treatment at 8 weeks
Fear of movement or (re)injury
Time frame: From enrollment to the end of treatment at 8 weeks

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 5 Aug 2025.
Derived from this study: PubMed 40392887Borges J, Monteiro D, Silva FM, Jacinto M, Pastilha T, Duarte-Mendes P. Effects of a land and aquatic exercise-based program on pain, mobility and quality of life in patients with chronic low back pain: a study protocol for a randomized controlled trial. PLoS One. 2025 May 20;20(5):e0320858. doi: 10.1371/journal.pone.0320858. eCollection 2025.
Individual participant dataSharing planned: No

Related trials for Chronic Low-back Pain (cLBP)

Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
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Not yet recruiting
Empowering Pain Psychology Access and Collaboration (EPPAC) to Improve Treatment Engagement Among Medicaid-insured Adults With Chronic Low Back Pain
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RecruitingObservational study
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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.

Joana Borges, PT principal investigator

Instituto Politécnico de Leiria

Diogo Monteiro, PhD study director

Instituto Politécnico de Leiria

Pedro Mendes, PhD study director

Instituto Politécnico de Castelo Branco

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 and Land-based Exercise Program in people with Chronic Low-back Pain (cLBP), run by Instituto Politécnico de Leiria 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 4 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: finished, as of the sponsor's last update on 5 Aug 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 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?

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 (time frame: From enrollment to the end of treatment at 8 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?

On the ClinicalTrials.gov record for NCT06641570, which also lists 1 linked publication.

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 5 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.