NCT00945971

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
10.2 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

July 14, 2009

Last Update Submit

August 15, 2019

Conditions

Keywords

Attention Deficit Hyperactivity DisorderCatecholamineChildrenPhysical Activity

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Physical activity

EXPERIMENTAL

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

Interventions

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.

Physical activity

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • children with ADHD on medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dan Nemet, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Eliakim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 24, 2009

Study Start

October 1, 2019

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations