search
Back to results

Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit/Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Catecholamine, Children, Physical Activity

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • children with ADHD on medications

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 14, 2009
Last Updated
August 15, 2019
Sponsor
Meir Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00945971
Brief Title
Exercise Effects in Children With Attention Deficit Hyperactivity Disorder
Official Title
Catecholamine and Cognitive Response to Exercise in Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Catecholamine, Children, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
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 Measure Information:
Title
Catecholamine (Epinephrine, NorEpinephrine, Dopamine) blood levels
Time Frame
baseline and after 3 months intervention
Title
Exercise testing
Time Frame
baseline and after 3 months intervention
Title
cognitive assessment
Description
will be performed at the start and in the end of the intervention (time 0 and 3 months).
Time Frame
baseline and after 3 months intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: boys and girls between the ages 6 and 18, with newly diagnosed ADHD. Exclusion Criteria: children with ADHD on medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Nemet, MD
Phone
972-9-7472134
Email
dan.nemet@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Eliakim, MD
Email
eliakim.alon@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD
Organizational Affiliation
Pediatrics, Meir Medical Center, Sackler School of Medicine, Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Nemet, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35816941
Citation
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.
Results Reference
derived

Learn more about this trial

Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

We'll reach out to this number within 24 hrs