The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents

December 13, 2023 updated by: Aviva Mimouni-Bloch, Loewenstein Hospital
The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is designed as a single-center, crossover, randomized study. 70 high-school aged males aged between 15 and 18 years with a diagnosis of ADHD who are being treated pharmacologically using stimulants (such as Ritalin, Concerta, Vyvanse etc) will be recruited. The study will investigate motor performance using several motor function tests both with and without the influence of stimulant ADHD medications.

Participants will be assessed on two separate occasions, both sessions will occur during the morning in their regular school environment. During the sessions, participants will be randomized, 50% will be assessed one hour after taking their usual stimulant ADHD medication and the other 50% will be asked to postpone taking their usual stimulant ADHD medication until the session is finished. During the two separate sessions, all participants will be asked to perform the following motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility tests and 20 m shuttle run tests (beeps).

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications

Description

Inclusion Criteria:

  • High school male students
  • Diagnosis of ADHD
  • Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).

Exclusion Criteria:

  • Students with concomitant chronic disease (including asthma, cardiac, motor, neurological and gastrointestinal disturbances)
  • History of acute illness in the previous two weeks
  • Any injuries that would inhibit the ability to exercise or play sport
  • Students unable to obtain parental/guardian consent
  • Students unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medicated
Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication.
Other: Motor performance tests
Performance of 5 motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility test and 20 m shuttle run tests (beeps), after taking ADHD drug or not taking the drug before motor tests performance
Unmedicated
Participants will remain unmedicated for the duration of the assessment, and will delay taking their usual stimulant ADHD medication until all the motor function assessments are completed.
Other: Motor performance tests
Performance of 5 motor tests: plank, single leg stance test, standing long jump test (broad jump), 4 x 10 agility test and 20 m shuttle run tests (beeps), after taking ADHD drug or not taking the drug before motor tests performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor tests
Time Frame: 5 minutes
Plank
5 minutes
Motor tests
Time Frame: 5 minutes
Single leg stance test
5 minutes
Motor tests
Time Frame: 5 minutes
Standing long jump test (broad jump)
5 minutes
Motor tests
Time Frame: 5 minutes
4 x 10 agility tests
5 minutes
Motor tests
Time Frame: 5 minutes
20 m shuttle run tests (beeps)
5 minutes
AAC-Q questionnaire
Time Frame: 10 minutes
Adolescents and Adults Coordination Questionnaire
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate at rest
Time Frame: 5 minutes
Heart rate will be measured in a sitting position
5 minutes
Blood pressure at rest
Time Frame: 5 minutes
Blood pressure will be measured in a sitting position
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loewenstein Hospital

Collaborators

Wingate Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0003-22-LOE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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