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Not yet recruiting NCT07732595

Combined and Aquatic Exercise in Chronic Low Back Pain

No phase Interventional Chronic Low-back Pain (cLBP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aquatic-exercise Program, Land-based Exercise Program, Home-based Exercise Program.
Who it may be relevant to
Registry conditions: Chronic Low-back Pain (cLBP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Combined-exercise and Aquatic-exercise on Pain, Disability and Functional Capacity in Patients With Chronic Low Back Pain

Overview

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.

Interventions

  • 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
  • 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).
  • 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.

Primary outcome measures

  • Visual Analogue Scale [Time frame: 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).]
  • Short Physical Performance Battery [Time frame: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]
Secondary outcome measures (5)
  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • University of Beira Interior — Covilha

Identifiers

NCT: NCT07732595 · CE-UBI-Pj-2026-064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗