Combined and Aquatic Exercise in Chronic Low Back Pain

July 28, 2026 updated by: Joana Catarina Carvalho Borges, University of Beira Interior

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
    • Castelo Branco District
      • Covilha, Castelo Branco District, Portugal, 6201-001
        • University of Beira Interior
        • Contact:
        • Principal Investigator:
          • Joana Borges, MSc
        • Principal Investigator:
          • Henrique Neiva, PhD
        • Principal Investigator:
          • Diogo Monteiro, PhD
        • Sub-Investigator:
          • Fernanda M. Silva, PhD
        • Sub-Investigator:
          • Tiago Pastilha, MSc
        • Principal Investigator:
          • Pedro Duarte-Mendes, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aquatic and Land Group
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.
Other: Aquatic-exercise Program

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.

Other: Land-based Exercise Program
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).
Experimental: Aquatic Group
This arm will comprise 24 sessions of the aquatic-exercise program (three non-consecutive sessions per week), conducted over an 8-week period.
Other: Aquatic-exercise Program

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.
Active Comparator: Home Group
This arm will include 24 sessions of the home-based exercise program (three non-consecutive sessions per week) over an 8-week period.
Other: Home-based Exercise Program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
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.
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
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.
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tampa Scale of Kinesiophobia-13
Time Frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).
Fear of movement will be assessed with the Tampa Scale of Kinesiophobia-13 (Minimum: 13; Maximum 52). Higher values correspond to worse outcome.
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).
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (Minimum: 0; Maximum 21). Higher values correspond to worse outcome.
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).
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.
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).
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.
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).
Lumbar spine range of motion will be assessed with the Modified-Modified Schober Test.
Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Beira Interior

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto Politécnico de Leiria
Instituto Politécnico de Castelo Branco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Diogo Monteiro, PhD, Instituto Politécnico de Leiria
  • Study Director: Pedro Duarte-Mendes, PhD, Instituto Politécnico de Castelo Branco
  • Study Director: Henrique Neiva, PhD, University of Beira Interior

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE-UBI-Pj-2026-064

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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