Combined and Aquatic Exercise in Chronic Low Back Pain

Официальное название

Effects of Combined-exercise and Aquatic-exercise on Pain, Disability and Functional Capacity in Patients With Chronic Low Back Pain

Обзор

The goal of this randomized clinical trial is to evaluate the effects of a combined aquatic- and land-based exercise program, as well as an aquatic-exercise program, compared with a control group receiving home-based exercise, on pain, disability, and functional capacity in adults with CLBP. Secondary objectives include examining the effects on fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility. The main question it aims to answer is: "Which type of exercise program is most effective at improving pain, disability, functional capacity, fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility in adults with chronic low back pain?". Participants will perform an aquatic-based exercise program (aquatic group), a combined aquatic and land-based exercise program (aquatic and land group), or a land-based exercise program (home group). Researchers will compare groups to find any differences in pain, disability, functional capacity, kinesiophobia, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility.

Вмешательства

• Другое Aquatic-exercise Program
  This intervention will consist of an aquatic-exercise program, performed in shallow water (120-150 cm deep) at a temperature of 32-34 °C, and supervised by a physiotherapist with over two years of experience in aquatic-based exercise and Ai Chi method. The aquatic-exercise sessions, will consist of a 5-minute warm-up phase, a 30-40-minute training phase, and a 10-15-minute relaxation/cool-down phase, adapted from Ai Chi exercise positions. The Ai Chi method consists of 19 katas (movements) that
• Другое Land-based Exercise Program
  This program will include specific land-based exercises, supervised by a physiotherapist with more than two years of experience in therapeutic exercise. The land-based exercise program, will be divided into three components: core stability exercises (15-20 minutes), trunk and lower limb stretching exercises (10-15 minutes), and relaxation/coordination exercises adapted from the Ai Chi method (10-15 minutes).
• Другое Home-based Exercise Program
  This exercise program will consist of a home-based exercise program. Each session will last 20-30 minutes and will be performed individually at home without professional supervision. The home-based exercise program will include core stability exercises that progress from the supine to the quadruped position. It will mirror the land-based exercise program and is adapted from a previous unsupervised home-based protocol.

Первичные конечные точки

• Visual Analogue Scale [Срок оценки: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]
• Oswestry Disability Index - version 2.0 [Срок оценки: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]
• Short Physical Performance Battery [Срок оценки: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]

Вторичные конечные точки (5)

• Tampa Scale of Kinesiophobia-13 [Срок оценки: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]
• Hospital Anxiety and Depression Scale [Срок оценки: One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).]
• Fixed Handheld Dynamometry for Assessing Quadriceps Strength [Срок оценки: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).]
• Hand-Grip Dynamometry [Срок оценки: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).]
• Modified-Modified Schober Test [Срок оценки: Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).]

Критерии участия

Критерии включения

• all genders;
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• University of Beira Interior — Covilha

Идентификаторы

NCT: NCT07732595 · CE-UBI-Pj-2026-064

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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