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

Recruiting

• Conditions: ADHD
• Interventions: Other: Motor performance tests

• Registration Number: NCT05517785
• Lead Sponsor: Loewenstein Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Study Start: 2023-02-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medicated	Motor performance tests	Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication.
Unmedicated	Motor performance tests	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.

Primary Outcome Measures

Name	Time	Method
AAC-Q questionnaire	10 minutes	Adolescents and Adults Coordination Questionnaire
Motor tests	5 minutes	20 m shuttle run tests (beeps)

Secondary Outcome Measures

Name	Time	Method
Heart rate at rest	5 minutes	Heart rate will be measured in a sitting position
Blood pressure at rest	5 minutes	Blood pressure will be measured in a sitting position

Trial Locations

Locations (1)

Sharon Tsuk; 🇮🇱 Netanya, Israel