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Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT00945971
Recruitment Status : Not yet recruiting
First Posted : July 24, 2009
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Other: Physical activity Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels [ Time Frame: baseline and after 3 months intervention ]
  2. Exercise testing [ Time Frame: baseline and after 3 months intervention ]
  3. cognitive assessment [ Time Frame: baseline and after 3 months intervention ]
    will be performed at the start and in the end of the intervention (time 0 and 3 months).



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • children with ADHD on medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945971


Contacts
Contact: Dan Nemet, MD 972-9-7472134 dan.nemet@clalit.org.il
Contact: Alon Eliakim, MD eliakim.alon@clalit.org.il

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel, 44281
Principal Investigator: Dan Nemet, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Dan Nemet, MD Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00945971     History of Changes
Other Study ID Numbers: MeirMc010-09CTIL
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meir Medical Center:
Attention Deficit Hyperactivity Disorder
Catecholamine
Children
Physical Activity

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms