- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03479658
Dose-effect of HIIT on Cardiovascular Health of Children
Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study
An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.
The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.
School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Navarra
-
Pamplona, Navarra, Spanje, 31008
- Department of Health Sciences, Universidad Pública de Navarra
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
All school children able to attend the physical education sessions of the school
-
Exclusion Criteria:
- Children with medical condition that limits physical activity
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: HIIT two sessions
Two sessions per week of HIIT + nutritional education (1 session/week)
|
Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old).
One of them has two physical education (PE) sessions per week and the other has only one PE session per week.
In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group.
Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup.
Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools.
The duration of the intervention will be of eight weeks.
School-based nutritional education on healthy dietary habits
|
|
Experimenteel: HIIT one session
One session per week of HIIT + nutritional education (1 session/week)
|
Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old).
One of them has two physical education (PE) sessions per week and the other has only one PE session per week.
In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group.
Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup.
Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools.
The duration of the intervention will be of eight weeks.
School-based nutritional education on healthy dietary habits
|
|
Actieve vergelijker: Nutritional education
Nutritional education (1 session/week)
|
School-based nutritional education on healthy dietary habits
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in cardiorespiratory fitness
Tijdsspanne: Change from baseline cardiorespiratory fitness at eight weeks
|
20m shuttle run test (Alpha battery)
|
Change from baseline cardiorespiratory fitness at eight weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Body fat
Tijdsspanne: Change from baseline body fat at eight weeks
|
Body fat percent measured by bioimpedance
|
Change from baseline body fat at eight weeks
|
|
Change in Ankle-brachial index
Tijdsspanne: Change from baseline Ankle-brachial index at eight weeks
|
Automated simultaneous blood pressure measurement
|
Change from baseline Ankle-brachial index at eight weeks
|
|
Change in Dietary habits
Tijdsspanne: Change from baseline Dietary habits at eight weeks
|
Food frequency questionnaire and 24h recall
|
Change from baseline Dietary habits at eight weeks
|
|
Change in Muscular strength
Tijdsspanne: Change from baseline Muscular strength at eight weeks
|
Handgrip strength and long jump (Alpha battery)
|
Change from baseline Muscular strength at eight weeks
|
|
Change in speed-agility
Tijdsspanne: Change from baseline speed agility at eight weeks
|
4x10m speed agility test (Alpha battery)
|
Change from baseline speed agility at eight weeks
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PI-018/17
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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 .
Klinische onderzoeken op High intensity interval training
-
Dana-Farber Cancer InstituteProstate Cancer FoundationActief, niet wervendProstaatneoplasmata | ProstaatkankerVerenigde Staten
-
University of Texas at AustinVoltooid
-
University of North Texas, Denton, TXUniversity of Alabama at Birmingham; Berry CollegeVoltooidMultiple scleroseVerenigde Staten
-
Oakland UniversityVoltooidGezondVerenigde Staten
-
University of Dublin, Trinity CollegeVoltooidLongneoplasmata | Colorectale neoplasmataIerland
-
Adiyaman UniversityActief, niet wervendHoge intensiteit interval training | Oefening psychologie | Aanpassing door OefentrainingTurkije (Türkiye)
-
Riphah International UniversityVoltooid
-
Umeå UniversityThe Swedish Research Council; Swedish Heart Lung Foundation; Riksförbundet HjärtLungVoltooidCOPD | Gezonde ouderenZweden
-
Riphah International UniversityWerving
-
University of CadizInstituto de investigación e innovación biomédica de CádizActief, niet wervendDiabetes mellitus, type 2Spanje