Combined and Aquatic Exercise in Chronic Low Back Pain
ConditionChronic Low-back Pain (cLBP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Beira Interior
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Aquatic-exercise Program
Other interventionThis 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 incorporate deep breathing, coordinated upper and lower limb actions, trunk control, and slow, continuous motion. In this study, only 10 of these 19 katas will be included in the aquatic-exercise protocol.
Land-based Exercise Program
Other interventionThis 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).
Home-based Exercise Program
Other interventionThis 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Aquatic and Land GroupExperimental treatment 2 interventions
Group B: Aquatic GroupExperimental treatment 1 intervention
Group C: Home GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale
Pain intensity will be assessed with the Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome.
Time frame
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).2
Oswestry Disability Index - version 2.0
Disability due to low back pain will be assessed with the Oswestry Disability Index (Minimum: 0; Maximum 100). Higher values correspond to worse outcome.
Time frame
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).3
Short Physical Performance Battery
Lower-limb functional capacity (balance, gait speed, chair stands) will be assessed with the Short Physical Performance Battery, a simple tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests. Each component is scored (0-4), yielding a composite score (0-12), with higher scores indicating better performance.
Time frame
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).Secondary outcomes
1
Tampa Scale of Kinesiophobia-13
Fear of movement will be assessed with the Tampa Scale of Kinesiophobia-13 (Minimum: 13; Maximum 52). Higher values correspond to worse outcome.
Time frame
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).2
Hospital Anxiety and Depression Scale
Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (Minimum: 0; Maximum 21). Higher values correspond to worse outcome.
Time frame
One measurement will be assessed at baseline and one at each follow-up (8 and 12 weeks).3
Fixed Handheld Dynamometry for Assessing Quadriceps Strength
Quadriceps muscle (both sides) maximum voluntary isometric contraction will be assessed with Fixed Handheld Dynamometry with participants seated and the knee positioned at approximately 90° of flexion.
Time frame
Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).4
Hand-Grip Dynamometry
Maximum isometric strength of the hand and forearm muscles (both sides) will be assessed with Hand-Grip Dynamometry with participants seated with the elbow flexed at 90° and the forearm in a neutral position.
Time frame
Three measurements will be assessed at baseline and three at each follow-up (8 and 12 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Beira Interior
Lead sponsor
Instituto Politécnico de Leiria
Collaborator
Instituto Politécnico de Castelo Branco
Collaborator
Source ClinicalTrials.gov
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