- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00945971
Exercise Effects in Children With Attention Deficit Hyperactivity Disorder
Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Kfar Saba, Israel, 44281
- Meir Medical Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- boys and girls between the ages 6 and 18, with newly diagnosed ADHD.
Exclusion Criteria:
- children with ADHD on medications
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels
Tidsram: baseline and after 3 months intervention
|
baseline and after 3 months intervention
|
|
|
Exercise testing
Tidsram: baseline and after 3 months intervention
|
baseline and after 3 months intervention
|
|
|
cognitive assessment
Tidsram: baseline and after 3 months intervention
|
will be performed at the start and in the end of the intervention (time 0 and 3 months).
|
baseline and after 3 months intervention
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dan Nemet, MD, Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MeirMc010-09CTIL
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