Clinical trial NCT00945971: Exercise Effects in Children With Attention Deficit Hyperactivity Disorder
Official title: Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
Catecholamine
Children
Physical Activity
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will investigate catecholamines responses, and cognitive effects of exercise in children with attention deficit hyperactivity disorder, and the effect of exercise training on these measures.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* boys and girls between the ages 6 and 18, with newly diagnosed ADHD.

Exclusion Criteria:

* children with ADHD on medications

Primary outcomes:
measure: Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels
timeFrame: baseline and after 3 months intervention
measure: Exercise testing
timeFrame: baseline and after 3 months intervention
measure: cognitive assessment
timeFrame: baseline and after 3 months intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
name: Dan Nemet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nemet D, Ben-Zaken S, Eliakim RA, Eliakim A. Reduced exercise-induced growth hormone secretion among children with attention-deficit hyperactivity disorder. Growth Horm IGF Res. 2022 Aug;65:101485. doi: 10.1016/j.ghir.2022.101485. Epub 2022 Jun 30.