- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
132
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Middlesbrough, Det Forenede Kongerige, TS30RH
- Outwood Academy Ormesby
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
11 år til 13 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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 indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kathryn L Weston, PhD, Teesside University, Middlesbrough, UK
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2016
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først indsendt
29. april 2016
Først indsendt, der opfyldte QC-kriterier
2. maj 2016
Først opslået (Skøn)
3. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TEES-046/16
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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