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- Klinische proef NCT02759432
Effect of a 4-week Fun Fast Interval Training (FFIT) Activity Programme on Physical Fitness and Quality of Life in Adolescent School Pupils
11 oktober 2017 bijgewerkt door: Kathryn Weston, Teesside University
Low-volume high-intensity interval exercise training may improve aspects of health and fitness in young people, but the effect of this type of exercise on quality of life has yet to be assessed.
The investigators aim to examine the effect of a 4-week school-based low-volume high-intensity interval training programme (called the Fun Fast Interval Training [FFIT] activity project) on physical fitness and quality of life in adolescent school pupils.
Approximately 145 English adolescents aged 11-12 years will be approached and invited to take part in the study.
Participants will be healthy female volunteers, recruited from one school in Northeast England.
Using a non-randomised design, one school year group will be assigned to take part in the intervention, and a second year group assigned to the control condition.Those in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme.
The intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest.
Participants will be encouraged to work maximally during the 45-s repetitions.
Control participants will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine.
Study outcomes will be 20 m shuttle run test performance, health-related quality of life, standing broad jump performance, hand dynamometer performance, waist circumference and 10 m and 20 m sprint performance.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
132
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Middlesbrough, Verenigd Koninkrijk, TS30RH
- Outwood Academy Ormesby
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
11 jaar tot 13 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Must be in school Year 7 or 8 at the school where the study will take place
- Must provide parental consent and participant assent
- Must be free from exclusion criteria
Exclusion Criteria:
- Symptoms of or known presence of heart disease or major atherosclerotic cardiovascular disease.
- Condition or injury or co-morbidity affecting the ability to undertake exercise.
- Diabetes mellitus
- Early family history of sudden death
- Pregnancy or likelihood of pregnancy
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention
Participants in the intervention group will complete a 4-week school-based high-intensity interval exercise training programme.
The intervention will take place twice per week, and comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and basketball drills), each interspersed with 90-s rest.
Participants will be encouraged to work maximally during the 45-s repetitions.
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Geen tussenkomst: Control
Participants in the control group will be instructed not to change their lifestyle, dietary or physical activity habits during the intervention period, and maintain their normal school physical education routine
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from baseline (0 weeks) cardiorespiratory fitness (assessed via the 20 m shuttle run test performance test) at the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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Cardiorespiratory fitness will be indirectly assessed by participants performing the 20 m shuttle run test.
Test performance is expressed in number of shuttle completed
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) leg power (assessed via standing broad jump performance at the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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Leg power will be assessed by participants performing a standing broad jump test.
Test performance is expressed as distance jumped.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) upper body strength (assessed via handgrip dynamometer performance) at the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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Upper body strength will be assessed by participants performing the handgrip dynamometer test.
Test performance is expressed as grip strength measured in kilogrammes.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) in 10 m running speed (assessed via 10 m sprint performance at) the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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10 m running speed will be assessed by participants completing a 10 m running sprint.
Test performance is expressed in seconds.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) in 20 m running speed (assessed via 20 m sprint performance at) the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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20 m running speed will be assessed by participants completing a 20 m running sprint.
Test performance is expressed in seconds.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) waist circumference at the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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Measurements will be expressed in centimetres.
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Baseline (0 weeks) and post-intervention (4 weeks)
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Change from baseline (0 weeks) health-related quality of life (assessed via completion of the Kid-Kindl questionnaire [Ravens-Sieberer & Bullinger, 2000] at the post-intervention time point (4 weeks)
Tijdsspanne: Baseline (0 weeks) and post-intervention (4 weeks)
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Baseline (0 weeks) and post-intervention (4 weeks)
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Heart rate during high-intensity interval exercise training sessions
Tijdsspanne: Up to 4 weeks
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Up to 4 weeks
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Rating of perceived exertion (assessed via the Children's scale of perceived exertion [Robertson et al., 2000) during high intensity interval exercise training sessions
Tijdsspanne: Up to 4 weeks
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Up to 4 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kathryn L Weston, PhD, Teesside University, Middlesbrough, UK
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2016
Primaire voltooiing (Werkelijk)
1 juli 2016
Studie voltooiing (Werkelijk)
1 juli 2016
Studieregistratiedata
Eerst ingediend
29 april 2016
Eerst ingediend dat voldeed aan de QC-criteria
2 mei 2016
Eerst geplaatst (Schatting)
3 mei 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 oktober 2017
Laatste update ingediend die voldeed aan QC-criteria
11 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- TEES-046/16
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .