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

NCT ID: NCT06641570

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low-back Pain (cLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Aquatic Exercise Program + Land-exercise Program

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.

Group Type EXPERIMENTAL

Aquatic Exercise Program

Intervention Type 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

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Aquatic Exercise Program

Intervention Type 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.

Interventions

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Aquatic Exercise Program

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.

Intervention Type OTHER

Land-based Exercise Program

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Politécnico de Castelo Branco

UNKNOWN

Sponsor Role collaborator

Instituto Politécnico de Leiria

OTHER

Sponsor Role lead

Responsible Party

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Joana Catarina Carvalho Borges

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joana Borges, PT

Role: PRINCIPAL_INVESTIGATOR

Instituto Politécnico de Leiria

Diogo Monteiro, PhD

Role: STUDY_DIRECTOR

Instituto Politécnico de Leiria

Pedro Mendes, PhD

Role: STUDY_DIRECTOR

Instituto Politécnico de Castelo Branco

Locations

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Polytechnic Institute of Leiria

Leiria, Leiria District, Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 40392887 (View on PubMed)

Other Identifiers

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CE/IPLEIRIA/47/2024

Identifier Type: -

Identifier Source: org_study_id

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