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- Klinische proef NCT00945971
Exercise Effects in Children With Attention Deficit Hyperactivity Disorder
Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
A leading pathophysiologic hypothesis of attention-deficit/hyperactivity disorder (ADHD) is based on the notion of a catecholamine [CA; norepinephrine (NE), epinephrine (EPI), and dopamine (DA)] dysfunction. This hypothesis suggests that the CA response to environmental stimuli is attenuated in ADHD and is derived primarily from observations that drugs such as methylphenidate and amphetamine - considered to be CA agonists - are effective in treating the symptoms of ADHD. Despite this compelling evidence, a definitive role of CA responsiveness in ADHD remains controversial. Physical activity is widely known to be a powerful stimulus of the hypothalamic-pituitary-adrenal (HPA) and noradrenergic systems. On the basis of the nation of a CA dysfunction in ADHD, we reasoned that the normal robust increase in circulating CA seen in response to exercise would be blunted in children with ADHD.
The objective of this study is to examine the possibility that exercise program and testing might be useful in differentiating CA responses to stress between children who had received a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and age- and gender-matched controls.
This study will take place in 'Children and adolescence health and sports center' in Meir Medical Center, Kfar-Saba, Israel. Forty-five children, boys and girls between the ages 6 and 18, with newly diagnosed ADHD that not receiving any drugs will be assigned to the intervention group. Age and gender matched children with ADHD, receiving Ritalin and not engaged in regular exercise, or healthy children's without ADHD will serve as controls. The intervention group will participate in an exercise program, including aerobic and anaerobic components, twice a week, for 3 months. Exercise testing, blood sampling and cognitive assessment will be performed at the start and in the end of this study.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kfar Saba, Israël, 44281
- Meir Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- boys and girls between the ages 6 and 18, with newly diagnosed ADHD.
Exclusion Criteria:
- children with ADHD on medications
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Physical activity
The intervention group will participate in an exercise program, including aerobic and anaerobic components,twice a week, for 3 months.
Exercise testing, blood sampling and cognitive assessment will be performed at the start and in the end of this study.
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The intervention group will engage in exercise program, including aerobic and anaerobic components,twice a week, for 3 months.
Exercise testing, blood sampling and cognitive assessment will be used at the start and in the end of this study.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels
Tijdsspanne: baseline and after 3 months intervention
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baseline and after 3 months intervention
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Exercise testing
Tijdsspanne: baseline and after 3 months intervention
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baseline and after 3 months intervention
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cognitive assessment
Tijdsspanne: baseline and after 3 months intervention
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will be performed at the start and in the end of the intervention (time 0 and 3 months).
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baseline and after 3 months intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dan Nemet, MD, Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MeirMc010-09CTIL
Informatie over medicijnen en apparaten, studiedocumenten
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