Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

NCT ID: NCT00945971

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-12-01

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.

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.

Conditions

Attention Deficit/Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical activity

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• children with ADHD on medications

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dan Nemet, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Central Contacts

Dan Nemet, MD

Role: CONTACT

dan.nemet@clalit.org.il

972-9-7472134

Alon Eliakim, MD

Role: CONTACT

eliakim.alon@clalit.org.il

References

Nemet D, Ben-Zaken S, Eliakim A. The effect of methylphenidate on the dopamine and growth hormone response to exercise in children with attention-deficit hyperactivity disorder. Growth Horm IGF Res. 2024 Jun;76:101596. doi: 10.1016/j.ghir.2024.101596. Epub 2024 May 27.

Reference Type: DERIVED

PMID: 38820857 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35816941 (View on PubMed)

Other Identifiers

MeirMc010-09CTIL

Identifier Type: -

Identifier Source: org_study_id