- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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 octobre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
132
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Middlesbrough, Royaume-Uni, TS30RH
- Outwood Academy Ormesby
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
11 ans à 13 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Baseline (0 weeks) and post-intervention (4 weeks)
|
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)
Délai: 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)
Délai: Baseline (0 weeks) and post-intervention (4 weeks)
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Baseline (0 weeks) and post-intervention (4 weeks)
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Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
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Heart rate during high-intensity interval exercise training sessions
Délai: 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
Délai: Up to 4 weeks
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Up to 4 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kathryn L Weston, PhD, Teesside University, Middlesbrough, UK
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2016
Achèvement primaire (Réel)
1 juillet 2016
Achèvement de l'étude (Réel)
1 juillet 2016
Dates d'inscription aux études
Première soumission
29 avril 2016
Première soumission répondant aux critères de contrôle qualité
2 mai 2016
Première publication (Estimation)
3 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- TEES-046/16
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