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

Not Applicable

Recruiting

• Conditions: Chronic Low-back Pain (cLBP)

• Registration Number: NCT06641570
• Lead Sponsor: Instituto Politécnico de Leiria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-30
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-10
• Study First Posted: 2024-10-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain	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.
Functional Disability	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.
Quality of life	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 Outcome Measures

Name	Time	Method
Lumbar spine range of motion	From enrollment to the end of treatment at 8 weeks	Quantitive variable evaluated with Modified-Modified Schober Test.
Fear of movement or (re)injury	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.

Trial Locations

Locations (1)

Polytechnic Institute of Leiria; 🇵🇹 Leiria, Portugal