Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00945971
First received: July 14, 2009
Last updated: March 9, 2014
Last verified: March 2014
  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

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 ] [ 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: August 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: March 9, 2014
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 July 22, 2014