The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents
1 other identifier
observational
70
1 country
1
Brief Summary
The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedDecember 20, 2023
December 1, 2023
1.3 years
August 16, 2022
December 13, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Motor tests
Plank
5 minutes
Motor tests
Single leg stance test
5 minutes
Motor tests
Standing long jump test (broad jump)
5 minutes
Motor tests
4 x 10 agility tests
5 minutes
Motor tests
20 m shuttle run tests (beeps)
5 minutes
AAC-Q questionnaire
Adolescents and Adults Coordination Questionnaire
10 minutes
Secondary Outcomes (2)
Heart rate at rest
5 minutes
Blood pressure at rest
5 minutes
Study Arms (2)
Medicated
Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication.
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.
Interventions
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
Eligibility Criteria
70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications
You may qualify if:
- High school male students
- Diagnosis of ADHD
- Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loewenstein Hospitallead
- Wingate Institutecollaborator
Study Sites (1)
Sharon Tsuk
Netanya, 42902, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Child Developmental Center
Study Record Dates
First Submitted
August 16, 2022
First Posted
August 26, 2022
Study Start
February 1, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
December 20, 2023
Record last verified: 2023-12