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NCT Number: NCT06641570

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

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.

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Key information

Conditions

Chronic Low-back Pain (cLBP) Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polytechnic Institute of Leiria

Leiria, Leiria District, 2411-901, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Aquatic Exercise Program

Other

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 program

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Lumbar spine range of motion

    Time frame: From enrollment to the end of treatment at 8 weeks

    Quantitive variable evaluated with Modified-Modified Schober Test.

  2. Fear of movement or (re)injury

    Time frame: From enrollment to the end of treatment at 8 weeks

    Quantitive variable evaluated with Tampa Scale of Kinesiophobia-13. (Minimum: 13; Maximum 52). Higher values correspond to worse outcome.

Sponsors and collaborators

Lead sponsor

Instituto Politécnico de Leiria

Other

Collaborators

  • Instituto Politécnico de Castelo Branco

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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