Exercise Effects in Children With Attention Deficit Hyperactivity Disorder
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Attention Deficit/Hyperactivity Disorder |
Other: Physical activity |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder |
- Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels [ Time Frame: baseline and after 3 months intervention ] [ Designated as safety issue: No ]
- Exercise testing [ Time Frame: baseline and after 3 months intervention ] [ Designated as safety issue: No ]
- cognitive assessment [ Time Frame: baseline and after 3 months intervention ] [ Designated as safety issue: No ]will be performed at the start and in the end of the intervention (time 0 and 3 months).
| Estimated Enrollment: | 45 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Other: Physical activity
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.
|
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| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- boys and girls between the ages 6 and 18, with newly diagnosed ADHD.
Exclusion Criteria:
- children with ADHD on medications
Contacts and Locations| Contact: Dan Nemet, MD | 972-9-7472134 | dan.nemet@clalit.org.il |
| Contact: Alon Eliakim, MD | eliakim.alon@clalit.org.il |
| Israel | |
| Meir Medical Center | Not yet recruiting |
| Kfar Saba, Israel, 44281 | |
| Principal Investigator: Dan Nemet, MD | |
| Principal Investigator: | Dan Nemet, MD | Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University |
More Information
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT00945971 History of Changes |
| Other Study ID Numbers: | MeirMc010-09CTIL |
| Study First Received: | July 14, 2009 |
| Last Updated: | February 11, 2013 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Meir Medical Center:
|
Attention Deficit Hyperactivity Disorder Catecholamine Children Physical Activity |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013