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Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

This study is not yet open for participant recruitment.
Verified March 2016 by Meir Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00945971
First Posted: July 24, 2009
Last Update Posted: March 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  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: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels [ Time Frame: baseline and after 3 months intervention ]
  • Exercise testing [ Time Frame: baseline and after 3 months intervention ]
  • 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).


Estimated Enrollment: 45
Study Start Date: December 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

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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
  Contacts and Locations
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
  More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00945971     History of Changes
Other Study ID Numbers: MeirMc010-09CTIL
First Submitted: July 14, 2009
First Posted: July 24, 2009
Last Update Posted: March 29, 2016
Last Verified: March 2016

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