Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit/Hyperactivity Disorder
• Intervention / Treatment: Other: Physical activity

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
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Nemet, MD; Phone Number: 972-9-7472134; Email: dan.nemet@clalit.org.il
• Study Contact Backup: Name: Alon Eliakim, MD; Email: eliakim.alon@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel, 44281
    • Meir Medical Center
    • Principal Investigator: Dan Nemet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• children with ADHD on medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels		baseline and after 3 months intervention
Exercise testing		baseline and after 3 months intervention
cognitive assessment	will be performed at the start and in the end of the intervention (time 0 and 3 months).	baseline and after 3 months intervention

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Dan Nemet, MD, Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Children; Attention Deficit Hyperactivity Disorder; Catecholamine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: MeirMc010-09CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No