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

NCT ID: NCT05517785

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medicated

Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication.

Motor performance tests

Intervention Type OTHER

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.

Motor performance tests

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wingate Institute

OTHER

Sponsor Role collaborator

Loewenstein Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aviva Mimouni-Bloch

Head of Child Developmental Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sharon Tsuk

Netanya, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aviva Mimouni-Bloch, Prof

Role: CONTACT

Phone: 7709085

Email: [email protected]

Sharon Tsuk, Ph.D

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sharon Tsuk

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0003-22-LOE

Identifier Type: -

Identifier Source: org_study_id