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| Name | Class |
|---|---|
| Instituto Politécnico de Castelo Branco | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aquatic Exercise Program + Land-exercise Program | Experimental | 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. |
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| Aquatic Exercise Program | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquatic Exercise Program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Quantitive variable evaluated with Visual Analogue Scale (Minimum: 0; Maximum 10). Higher values correspond to worse outcome. | From enrollment to the end of treatment at 8 weeks |
| Functional Disability | Quantitive variable evaluated with Oswestry Disability Index - version 2.0. (Minimum: 0; Maximum 100). Higher values correspond to worse outcome. | From enrollment to the end of treatment at 8 weeks |
| Quality of life | Quantitive variable evaluated with MOS Short Form Health Survey 36 Item v2. (Minimum: 0; Maximum 100). Higher values correspond to better outcome. | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine range of motion | Quantitive variable evaluated with Modified-Modified Schober Test. | From enrollment to the end of treatment at 8 weeks |
| Fear of movement or (re)injury | Quantitive variable evaluated with Tampa Scale of Kinesiophobia-13. (Minimum: 13; Maximum 52). Higher values correspond to worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joana Borges, PT | Instituto Politécnico de Leiria | Principal Investigator |
| Diogo Monteiro, PhD | Instituto Politécnico de Leiria | Study Director |
| Pedro Mendes, PhD | Instituto Politécnico de Castelo Branco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polytechnic Institute of Leiria | Leiria | Leiria District | 2411-901 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40392887 | Derived | 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. |
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| Land-based Exercise Program | 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. |
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| From enrollment to the end of treatment at 8 weeks |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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