- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07760103
Core Endurance Versus Segmental Stabilization Exercise in Recreational Athletes With Low Back Pain
Comparison of the Effects of Core Endurance Exercises and Segmental Stabilization Exercises on Low Back Pain and Core Endurance in Recreational Athletes With Non-Specific Low Back Pain: A Randomized Trial
Přehled studie
Postavení
Podmínky
Detailní popis
Design and setting This is a two-arm, parallel-group randomized trial conducted at a sports club facility.
Institutional permission for the study site has been obtained. Participants Recreational athletes who have recently begun regular physical activity and who report non-specific low back pain are enrolled. Participants provide written informed consent after receiving detailed information about the purpose of the study, the tests to be performed, and the exercise protocol. Sampling and randomization Convenience sampling is used to identify eligible participants, followed by simple random allocation to one of the two exercise groups: the core endurance exercise group or the segmental stabilization exercise group. Allocation is 1:1. Interventions Both exercise programs are delivered three days per week for six weeks. Segmental stabilization group: exercises target the transversus abdominis and lumbar multifidus and comprise stabilization exercises in the quadruped position, transversus abdominis activation exercises in the supine position with the knees flexed, lumbar multifidus activation exercises in the prone position, and standing postural control exercises involving co-activation of the transversus abdominis and lumbar multifidus.
Core endurance group: exercises are performed under the supervision of a certified physiotherapist and comprise the front plank, the side plank, and the superman plank.
Each exercise consists of 20 repetitions with a 15-second isometric hold per repetition.
The set is repeated twice, with a 3-minute rest between sets. In the front plank the participant is supported on the forearms and toes, with the shoulders aligned over the elbows and the trunk and lower limbs maintained in a straight line, producing simultaneous activation of the abdominal and paraspinal muscles. In the side plank the participant is supported on one forearm with the body held in a straight line, the shoulder aligned with the elbow and the pelvis lifted from the floor, targeting the oblique muscles. In the superman plank the participant lies prone with the arms extended overhead and simultaneously lifts the upper and lower limbs from the floor, producing trunk extension and targeting the lumbar extensor muscles. Outcome assessment Assessments are performed at baseline (week 0) and at the end of the six-week program (week 6). Demographic information including age, sex, and sports history is recorded.
Functional status and pain are assessed with the Micheli Functional Scale, dynamic balance with the Star Excursion Balance Test, and core muscle endurance with clinical endurance tests. Variables The independent variable is the type of exercise program (core endurance exercises versus segmental stabilization exercises). The dependent variables are pain level, core muscle endurance, and dynamic balance performance. Statistical analysis Normality of distribution is assessed with histogram curves and the Shapiro-Wilk test, and homogeneity of variance with the Levene test. Parametric or non-parametric tests are selected accordingly. Analyses are performed with IBM SPSS Statistics 20. Independent samples t-tests are used to compare demographic characteristics between groups. Multivariate analysis of variance is used to evaluate between-group and within-group changes, with time (baseline and post-intervention measurements) as the within-subject factor and group as the between-subject factor. Where a statistically significant difference is found, post-hoc analyses are performed with the Tukey test. Change scores between groups are also compared with independent samples t-tests.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: ömer şevgin
- Telefonní číslo: +905069787535
- E-mail: omer.sevgin@uskudar.edu.tr
Studijní místa
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Istanbul, Turecko (Türkiye)
- Nábor
- Fitness club gym
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Kontakt:
- Armita Chitsaz
- Telefonní číslo: +905456052365
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Aged 18 years or older
- Recreational athlete who has recently begun regular physical activity
- Diagnosis of non-specific low back pain confirmed by an orthopaedic specialist
- Two or more episodes of low back pain within the past year
- Not participating in any other treatment program during the study period
Exclusion Criteria:
- Radicular (nerve root) signs
- Underlying systemic or visceral disease
- Diagnosis of ankylosing spondylitis
- Spinal pathology such as spondylolysis or spondylolisthesis
- Previous lumbar spine surgery
- History of vestibular dysfunction
- Lower extremity injury within the past month
- History of traumatic concussion within the past three months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Core endurance exercise
Participants perform a core endurance exercise program consisting of the front plank, the side plank, and the superman plank, three days per week for six weeks under physiotherapist supervision.
Each exercise consists of 20 repetitions with a 15-second isometric hold, repeated for two sets with a 3-minute rest between sets.
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Supervised isometric core endurance training comprising the front plank, side plank, and superman plank. Each exercise: 20 repetitions of a 15-second isometric hold, two sets, 3-minute rest between sets. Three sessions per week for six weeks.
Supervised motor-control training targeting the transversus abdominis and lumbar multifidus, comprising quadruped stabilization, supine transversus abdominis activation with knees flexed, prone lumbar multifidus activation, and standing postural control with co-activation of both muscles.
Three sessions per week for six weeks.
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Aktivní komparátor: Segmental stabilization exercise
Participants perform a segmental stabilization exercise program targeting the transversus abdominis and lumbar multifidus, three days per week for six weeks under physiotherapist supervision.
The program comprises quadruped stabilization exercises, supine transversus abdominis activation with the knees flexed, prone lumbar multifidus activation, and standing postural control exercises involving co-activation of both muscles.
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Supervised isometric core endurance training comprising the front plank, side plank, and superman plank. Each exercise: 20 repetitions of a 15-second isometric hold, two sets, 3-minute rest between sets. Three sessions per week for six weeks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in low back pain and functional status (Micheli Functional Scale)
Časové okno: Baseline (week 0) and at the end of the six-week exercise program (week 6)
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The Micheli Functional Scale is a five-item scale developed to assess low back pain related functional impairment and pain related changes in performance in athletes.
It comprises one symptom question, three activity questions (extension, flexion, and jumping), and a visual analogue scale section.
The symptom question is scored from 0 to 5; the activity questions are scored from 0 to 4 for extension, from 0 to 3 for flexion, and from 0 to 3 for jumping.
The visual analogue scale section provides a 10-point assessment on a 10 cm line.
The total score is calculated out of 25 and multiplied by 4 to produce a standardized score from 0 to 100.
Lower scores indicate better functional status and higher scores indicate greater functional impairment.
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Baseline (week 0) and at the end of the six-week exercise program (week 6)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Armita Chitsaz, Uskudar University
Publikace a užitečné odkazy
Obecné publikace
- Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.
- Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- Dal Farra F, Arippa F, Carta G, Segreto M, Porcu E, Monticone M. Sport and non-specific low back pain in athletes: a scoping review. BMC Sports Sci Med Rehabil. 2022 Dec 23;14(1):216. doi: 10.1186/s13102-022-00609-9.
- Mortazavi J, Zebardast J, Mirzashahi B. Low Back Pain in Athletes. Asian J Sports Med. 2015 Jun;6(2):e24718. doi: 10.5812/asjsm.6(2)2015.24718. Epub 2015 Jun 20.
- Blanco-Gimenez P, Vicente-Mampel J, Gargallo P, Maroto-Izquierdo S, Martin-Ruiz J, Jaenada-Carrilero E, Barrios C. Effect of exercise and manual therapy or kinesiotaping on sEMG and pain perception in chronic low back pain: a randomized trial. BMC Musculoskelet Disord. 2024 Jul 25;25(1):583. doi: 10.1186/s12891-024-07667-9.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Uskudar27
- Uskudar University (Jiný identifikátor: Non-Interventional Research Ethics Committee)
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