Combined and Aquatic Exercise in Chronic Low Back Pain

NCT07732595 | Not Yet Recruiting DMC

• 1 other identifier: CE-UBI-Pj-2026-064
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Back Pain; Disability; Exercise; Aquatic Therapy; Physical Capacity

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale

  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

  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

  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 Outcomes (5)

• Tampa Scale of Kinesiophobia-13

  One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).

• Hospital Anxiety and Depression Scale

  One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).

• Fixed Handheld Dynamometry for Assessing Quadriceps Strength

  Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).

• Hand-Grip Dynamometry

  Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).

• Modified-Modified Schober Test

  Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).

Study Arms (3)

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.

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.

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.

Other: Home-based Exercise Program

Interventions

Aquatic-exercise Program OTHER

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.

Aquatic Group; Aquatic and Land Group

Land-based Exercise Program OTHER

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).

Aquatic and Land Group

Home-based Exercise Program OTHER

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.

Home Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Beira Interior: lead
• Instituto Politécnico de Leiria: collaborator
• Instituto Politécnico de Castelo Branco: collaborator

Study Sites (1)

University of Beira Interior

Covilha, Castelo Branco District, 6201-001, Portugal

Location

MeSH Terms

Conditions

Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Pedro Duarte-Mendes, PhD

  Instituto Politécnico de Castelo Branco

  STUDY DIRECTOR

• Henrique Neiva, PhD

  University of Beira Interior

  STUDY DIRECTOR

• Diogo Monteiro, PhD

  Instituto Politécnico de Leiria

  STUDY DIRECTOR

Central Study Contacts

Joana Borges, MSc

CONTACT

+351964928447; joanaccborges24@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly allocated to three groups in a 1:1:1 allocation ratio.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)