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

NCT06641570 | Completed DMC

• 1 other identifier: CE/IPLEIRIA/47/2024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Keywords

Pain; Exercise; Hydrotherapy; Aquatic Therapy; Disability

Outcome Measures

Primary Outcomes (3)

• Pain

  Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.

  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.

  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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• Lumbar spine range of motion

  From enrollment to the end of treatment at 8 weeks

• Fear of movement or (re)injury

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

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.

Other: Aquatic Exercise Program

Interventions

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.

Aquatic Exercise Program; Aquatic Exercise Program + Land-exercise Program

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.

Aquatic Exercise Program + Land-exercise Program

Eligibility Criteria

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

You may qualify if:

• 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.

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

• Instituto Politécnico de Leiria: lead
• Instituto Politécnico de Castelo Branco: collaborator

Study Sites (1)

Polytechnic Institute of Leiria

Leiria, Leiria District, 2411-901, Portugal

Location

Related Publications (1)

• 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.

  PMID: 40392887 DERIVED

MeSH Terms

Conditions

Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Joana Borges, PT

  Instituto Politécnico de Leiria

  PRINCIPAL INVESTIGATOR

• Diogo Monteiro, PhD

  Instituto Politécnico de Leiria

  STUDY DIRECTOR

• Pedro Mendes, PhD

  Instituto Politécnico de Castelo Branco

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 30, 2024
• Primary Completion: March 31, 2025
• Study Completion: April 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)