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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517785
• Other study ID #: 0003-22-LOE
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Loewenstein Hospital
• Contact: Aviva Mimouni-Bloch, Prof
• Phone: 7709085
• Email: abloch[@]clalit.org.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
Israel	Sharon Tsuk	Netanya

Sponsors (2)

Lead Sponsor	Collaborator
Loewenstein Hospital	Wingate Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor tests	Plank	5 minutes
Primary	Motor tests	Single leg stance test	5 minutes
Primary	Motor tests	Standing long jump test (broad jump)	5 minutes
Primary	Motor tests	4 x 10 agility tests	5 minutes
Primary	Motor tests	20 m shuttle run tests (beeps)	5 minutes
Primary	AAC-Q questionnaire	Adolescents and Adults Coordination Questionnaire	10 minutes
Secondary	Heart rate at rest	Heart rate will be measured in a sitting position	5 minutes
Secondary	Blood pressure at rest	Blood pressure will be measured in a sitting position	5 minutes