- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
132
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Middlesbrough, Storbritannia, TS30RH
- Outwood Academy Ormesby
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
11 år til 13 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline (0 weeks) and post-intervention (4 weeks)
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Baseline (0 weeks) and post-intervention (4 weeks)
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Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Heart rate during high-intensity interval exercise training sessions
Tidsramme: 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
Tidsramme: Up to 4 weeks
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Up to 4 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kathryn L Weston, PhD, Teesside University, Middlesbrough, UK
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2016
Primær fullføring (Faktiske)
1. juli 2016
Studiet fullført (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først innsendt
29. april 2016
Først innsendt som oppfylte QC-kriteriene
2. mai 2016
Først lagt ut (Anslag)
3. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- TEES-046/16
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .