Clinical trial NCT06641570: Effects of a Land and Aquatic Exercise-based Program on Pain, Mobility and Quality of Life in Patients with Chronic Low Back Pain
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain (cLBP)
Keywords: Pain
Exercise
Hydrotherapy
Aquatic Therapy
Disability
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
Collaborators: name: Instituto PolitÃ©cnico de Castelo Branco
First posted: 2024-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Functional Disability
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Quality of life
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Lumbar spine range of motion
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Fear of movement or (re)injury
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Leiria
country: Portugal
facility: Polytechnic Institute of Leiria
Study officials:
affiliation: Instituto Politécnico de Leiria
name: Joana Borges, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Politécnico de Leiria
name: Diogo Monteiro, PhD
role: STUDY_DIRECTOR
affiliation: Instituto Politécnico de Castelo Branco
name: Pedro Mendes, PhD
role: STUDY_DIRECTOR
References: