ADHDNCT05517785
The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents
An observational study of ADHD, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents. Read more about this study
- Who is it for?
- Ages 15 to 18 years, men only
- Conditions the study is for
- ADHD
- What is being tested?
- Motor performance tests
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: 70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications
Who may be able to join
- High school male students
- Diagnosis of ADHD
- Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sharon Tsuk, Ph.D contact
Israel1 site, 1 recruiting
- Recruiting
Sharon Tsuk
Netanya, 42902
Sharon Tsuk, sharontsuk1@gmail.com
About this study
The aim of this study is to evaluate the effects of stimulant ADHD pharmacotherapy on motor performance in male adolescents.
Read the 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).
- Conditions
- ADHD
- Being tested
- Motor performance tests
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor performance testsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Medicated | Assessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication. Receives: Other: Motor performance tests | |
| 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. Receives: Other: Motor performance tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor tests
Plank
Measured: 5 minutes
Motor tests
Single leg stance test
Measured: 5 minutes
Motor tests
Standing long jump test (broad jump)
Measured: 5 minutes
Motor tests
4 x 10 agility tests
Measured: 5 minutes
Motor tests
20 m shuttle run tests (beeps)
Measured: 5 minutes
AAC-Q questionnaire
Adolescents and Adults Coordination Questionnaire
Measured: 10 minutes
Secondary outcomes (2)
Heart rate at rest
Heart rate will be measured in a sitting position
Measured: 5 minutes
Blood pressure at rest
Blood pressure will be measured in a sitting position
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Feb 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wingate Institute
- Responsible party
- Principal investigator, Aviva Mimouni-Bloch, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517785
- Sponsor's protocol ID
- 0003-22-LOE
- Status last verified
- Dec 2023
- First submitted
- 16 Aug 2022
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pharmacological Treatment for ADHD on Physical Performance in Male Adolescents
- ClinicalTrials.gov ID
- NCT05517785
- Acronym / sponsor ID
- 0003-22-LOE
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Wingate Institute
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicated | – | Other: Motor performance testsAssessment of motor function will be performed 1 hour after taking the usual stimulant ADHD medication. |
| Unmedicated | – | Other: Motor performance testsParticipants 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. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 70 high school boys ages 15-18 years, diagnosed with ADHD and treated with stimulant medications
Key inclusion criteria (3 listed)
- High school male students
- Diagnosis of ADHD
- Treatment with prescribed stimulants for ADHD (e.g. Concerta, Ritalin, Phenidin, Focalin etc.).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor performance testsPerformance 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 | Other | Medicated, Unmedicated |
Primary outcome
Motor tests
Time frame: 5 minutes
Plank
Motor tests
Time frame: 5 minutes
Single leg stance test
Motor tests
Time frame: 5 minutes
Standing long jump test (broad jump)
Motor tests
Time frame: 5 minutes
4 x 10 agility tests
Motor tests
Time frame: 5 minutes
20 m shuttle run tests (beeps)
AAC-Q questionnaire
Time frame: 10 minutes
Adolescents and Adults Coordination Questionnaire
2 secondary outcomes
Heart rate at rest
Time frame: 5 minutes
Blood pressure at rest
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
Related trials for ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
AI-assisted Home-based Intervention for ADHD Children
ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined Type
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Tsuk, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviva Mimouni-Bloch, Prof (7709085 ext. 972 9, abloch@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor tests (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.