- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04778215
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts
Prevention and Treatment of Low Back Pain in Young Female TeamGym Gymnasts - a Cluster Randomized Controlled Intervention Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Objectives: To study if a progressive specific lumbar stabilization program can reduce and prevent low back pain (LBP) in young female TeamGym (TG) gymnasts aged 10-16 years.
Design A cluster randomized controlled intervention study
Participants: All available competitive youth female TG teams including gymnasts aged 10-16 years, in the area of Stockholm, were invited to participate in the present study. A team consists of approximately 16 gymnasts. Fourteen out of 17 teams and a total of 258 gymnasts accepted to participate. Gymnasts and parents were informed about the study and written consent was collected. A cluster randomization process was undertaken as follows: the gymnasts in each team answered questions at inclusion and the teams were matched with respect to age, level of competition, amount of training sessions per week and reports of LBP. LBP in this study was defined as; "pain between the 12th rib and the gluteal fold". Thereafter a cluster randomization took place. This means that all gymnasts in one team were either in the control or in the intervention group. There were no differences with respect to demographic and training data and reports of LBP between the two groups at randomization. Ninety gymnasts did not report LBP at inclusion or during baseline and were included in a subgroup analysis on the preventive effect of the exercise program.
Methods Every week the gymnasts were visited by a registered physical therapist (RPT). The RPT answered questions from the gymnasts concerning injuries and collected a weekly-based questionnaire. The gymnasts in the intervention group were instructed to perform an eight-week progressive specific lumbar stabilization program, implemented in the warm-up at every training session. The gymnasts answered a weekly based questionnaire regarding training and LBP during the intervention period, and thereafter a questionnaire at 3-, 6- and 12 months follow-up. The gymnasts and the coaches were also instructed to continue with the lumbar stabilization program after the intervention period.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Stockholm, Švédsko, 171 76 Stockholm
- Karolinska Institutet, Department of Molecular Medicine and Surgery, Stockholm Sports Trauma Research Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- female TeamGym teams, aged 10-16 years, in the Stockholm area
- competing at national or international level
Exclusion Criteria:
- male TeamGym gymnasts
- female TeamGym teams on a regional competitive level
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Intervention group
progressive, 8 week lumbar stabilizing program
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The aim of these programs is to optimize the stabilization and control of segmental motion of the lumbar spine.
It is based on the draw-in action, hereafter called the abdominal hollowing, presented by Richardson and Jull (1995).
The training program consists of three levels.
Level 1 introduces the abdominal hollowing exercise in the prone and four-point kneeling position.
Level 2 is a progression of these exercises and the gymnasts are also instructed to perform the abdominal hollowing standing on a balance board with slightly flexed knees while slowly moving the arms.
Level 3 takes the training into sports specificity and the abdominal hollowing are to be held during three different basic trampette jumps with emphasis on good trunk and body control during jumping and landing.
Ostatní jména:
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Žádný zásah: Control group
Continue as usual
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Weekly prevalence of LBP from baseline to end of the intervention program
Časové okno: 3 months
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Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
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3 months
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Weekly prevalence of SLBP (Substantial LBP) from baseline to end of the intervention program
Časové okno: 3 months
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Number of gymnasts reporting LBP 3 days or more or modification of participation (SLBP)/ Total number of gymnasts' reports; comparing the intervention and control group
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3 months
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Prevalence of LBP at 3-, 6- and 12 months follow up
Časové okno: 18 months
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Number of gymnasts reporting LBP/ Total number of gymnasts' reports; comparing the intervention and control group
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18 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change of Intensity and prevalence of LBP in gymnasts that report SLBP at the start of the study - from baseline to end of intervention, and at 3-, 6- and 12 months follow-up
Časové okno: 18 months
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Subgroup analysis including gymnasts with SLBP at the start of the study; comparing intervention and control group
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18 months
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Prevention of LBP evaluated after intervention and at 3-, 6- and 12 months
Časové okno: 18 months
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Subgroup analysis including gymnasts with no previous LBP at the start of the study; comparing intervention and control group
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18 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Marita L Harringe, PhD,RPT, Karolinska Institutet
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KI2009/1414-31/3
- Dnr 4646/2011-631 (Jiný identifikátor: PUL, Karolinska Institutet, Sweden)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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