Attention Deficit DisorderPhase 2/3NCT05243186
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
A Phase 2/3 study testing Treadmill workstation and Methylphenidate in people with Attention Deficit Disorder, run by Ariel University at 1 site in Israel.
Trial summary
Randomized clinical trial in which individuals who have been diagnosed with ADHD and are regularly treated with Methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions: While taking Methylphenidate and sitting at a desk While taking Methylphenidate and… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- Treadmill workstation and Methylphenidate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2021to Oct 2022
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Insured by Maccabi Health Services
- Diagnosed with ADHD by Neurologist/Psychiatrist/Developmental Doctor
- Take Methylphenidate as part of the treatment for ADHD AND have agreed to not take the drug if asked to
- Understand the language and simple instruction
- Willing to participate in the study and sign the agreement form
Who cannot join
- Suffer from heart disease or chronic respiratory illness
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ariel University
Ariel, 40700
Liat Korn, PhD, 972 50 9099201, Liatk@ariel.ac.il
Gideon Koren, MD, 972 58 7194777, gidiup_2000@yahoo.com
About this study
Randomized clinical trial in which individuals who have been diagnosed with ADHD and are regularly treated with Methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions:
- While taking Methylphenidate and sitting at a desk
- While taking Methylphenidate and walking on a treadmill workstation
- Without taking Methylphenidate while sitting at a desk
- Without taking Methylphenidate while walking on a treadmill workstation The investigators will compare the cognitive achievements outcomes and evaluate the efficiency of studying in each of these four conditions.
Read the detailed description
The rationale of this clinical trial is to identify the intervention that best contributes to better cognition results of adults with ADHD's: physical activity, drug or a combination of the two? The study will enable to determine which factor will improve cognitive results. The findings of this trial will help determine the best treatment method that can be offer to adults with ADHD.
- Conditions
- Attention Deficit Disorder
- Being tested
- Treadmill workstation, Methylphenidate
- Keywords
- Attention Deficit Disorder, Cognitive performance, Treadmill
- 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.
Treadmill workstationDevice
Also called Walking on a treadmill workstation
walking on a treadmill workstation next to desk with computer and screen
MethylphenidateDrug
Also called Ritalin
Using prescription drug
| Study group | Role | What they receive |
|---|---|---|
| MPH walking | Experimental | The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation Receives: Device: Treadmill workstation; Drug: Methylphenidate |
| MPH sitting | Placebo comparator | The participants will be instructed to work while taking Methylphenidate and sitting at a desk Receives: Drug: Methylphenidate |
| No MPH walking | Placebo comparator | The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation Receives: Device: Treadmill workstation |
| No MPH sitting | Placebo comparator | The participants will be instructed to work without taking Methylphenidate while sitting at a desk Receives: Device: Treadmill workstation; Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop performance
The Stroop task measures selectivity and distraction and evaluate the inhibitory ability. In this task a word is displayed in two coloured rectangles. Three states are included: Neutral state- where the word is colored in black; Congruent state- word's meaning and its color correspond; Non-congruent state- word's meaning does not match the color. For each state, parameters are shown separately. Calculated parameters include Mean reaction time of correct responses± the standard deviation of correct reaction times and errors- number of incorrect responses, where subjects pressed the wrong key. The scale of mean response time displays the mean score number of milliseconds for a subject to response (higher number present longer time of response- worse outcome). Higher standard deviation indicates larger distribution among the averages of the subjects. Errors count the times that subjects made mistakes in their answers starting from zero- higher score means worse outcome.
Measured: Through study completion, an average of 1 year
Barhatt performance
Barhatt performance is a validated questionnaire that includ 30 statements designed to assess impulsivity. The values on a 4-point scale rang from 1 ("never/rarely "), 2 ("sometimes"), 3 ("frequently"), and 4 ("almost always/always"). These statements create three subscales/ dimensions: 1. Motor Impulsiveness (MI), which reflects action without forethought (for example, "I do things without thinking"), 2. Attentional Impulsiveness (AI), which reflects a reduced ability to maintain attention toward a stimulus (for example, "I concentrate easily"), and 3. Non-Planning Impulsiveness (N-PI), which reflects an emphasis on the present (for example, "I am more interested in the present than the future"). In all these three dimensions higher mean score represent higher impulsivity.
Measured: Through study completion, an average of 1 year
Breaks from work
Number and length of breaks the participants took from their cognitive work. The values represent the mean number of breaks subjects took during their working time, higher numbers represent more breaks. As well the mean time of breaks in minutes where higher number represents longer time of break.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start1 Oct 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit DisorderStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will participate in four different sessions of the study that will be randomly crossed over.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
- Investigators
- Liat Korn, PhD, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243186
- Sponsor's protocol ID
- ArielUni
- Status last verified
- Oct 2021
- First submitted
- 23 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The result of the study will be analyzed. A paper will be submitted to an international journal with study description including methods, examination protocol results.
Publications
Korn L, Hassan K, Fainshtein N, Yusov N, Davidovitch N. Non-Medical Use of Prescription Stimulants for Treatment of Attention Disorders by University Students: Characteristics and Associations. Med Sci Monit. 2019 May 21;25:3778-3787. doi: 10.12659/MSM.913973.
PubMed 31111829
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
- ClinicalTrials.gov ID
- NCT05243186
- Acronym / sponsor ID
- ArielUni
- Conditions
- Attention Deficit Disorder
- Keywords
- Attention Deficit Disorder, Cognitive performance, Treadmill
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Maccabi Healthcare Services, Israel
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 16 Feb 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.
Randomized clinical trial in which individuals who have been diagnosed with ADHD and are regularly treated with Methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions:
- While taking Methylphenidate and sitting at a desk
- While taking Methylphenidate and walking on a treadmill workstation
- Without taking Methylphenidate while sitting at a desk
- Without taking Methylphenidate while walking on a treadmill workstation The investigators will compare the cognitive achievements outcomes and evaluate the efficiency of studying in each of these four conditions.
Detailed description
The rationale of this clinical trial is to identify the intervention that best contributes to better cognition results of adults with ADHD's: physical activity, drug or a combination of the two? The study will enable to determine which factor will improve cognitive results. The findings of this trial will help determine the best treatment method that can be offer to adults with ADHD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All participants will participate in four different sessions of the study that will be randomly crossed over.
| Arm | Type | Receives |
|---|---|---|
| MPH walking | Experimental | Device: Treadmill workstation, Drug: MethylphenidateThe participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation |
| MPH sitting | Placebo comparator | Drug: MethylphenidateThe participants will be instructed to work while taking Methylphenidate and sitting at a desk |
| No MPH walking | Placebo comparator | Device: Treadmill workstationThe participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation |
| No MPH sitting | Placebo comparator | Device: Treadmill workstation, Drug: MethylphenidateThe participants will be instructed to work without taking Methylphenidate while sitting at a desk |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Insured by Maccabi Health Services
- Diagnosed with ADHD by Neurologist/Psychiatrist/Developmental Doctor
- Take Methylphenidate as part of the treatment for ADHD AND have agreed to not take the drug if asked to
- Understand the language and simple instruction
- Willing to participate in the study and sign the agreement form
Key exclusion criteria (2 listed)
- Suffer from heart disease or chronic respiratory illness
- Women who are pregnant
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 |
|---|---|---|
| Treadmill workstationAlso: Walking on a treadmill workstationwalking on a treadmill workstation next to desk with computer and screen | Device | MPH walking, No MPH sitting, No MPH walking |
| MethylphenidateAlso: RitalinUsing prescription drug | Drug | MPH sitting, MPH walking, No MPH sitting |
Primary outcome
Stroop performance
Time frame: Through study completion, an average of 1 year
The Stroop task measures selectivity and distraction and evaluate the inhibitory ability. In this task a word is displayed in two coloured rectangles. Three states are included: Neutral state- where the word is colored in black; Congruent state- word's meaning and its color correspond; Non-congruent state- word's meaning does not match the color. For each state, parameters are shown separately. Calculated parameters include Mean reaction time of correct responses± the standard deviation of correct reaction times and errors- number of incorrect responses, where subjects pressed the wrong key. The scale of mean response time displays the mean score number of milliseconds for a subject to response (higher number present longer time of response- worse outcome). Higher standard deviation indicates larger distribution among the averages of the subjects. Errors count the times that subjects made mistakes in their answers starting from zero- higher score means worse outcome.
Barhatt performance
Time frame: Through study completion, an average of 1 year
Barhatt performance is a validated questionnaire that includ 30 statements designed to assess impulsivity. The values on a 4-point scale rang from 1 ("never/rarely "), 2 ("sometimes"), 3 ("frequently"), and 4 ("almost always/always"). These statements create three subscales/ dimensions: 1. Motor Impulsiveness (MI), which reflects action without forethought (for example, "I do things without thinking"), 2. Attentional Impulsiveness (AI), which reflects a reduced ability to maintain attention toward a stimulus (for example, "I concentrate easily"), and 3. Non-Planning Impulsiveness (N-PI), which reflects an emphasis on the present (for example, "I am more interested in the present than the future"). In all these three dimensions higher mean score represent higher impulsivity.
Breaks from work
Time frame: Through study completion, an average of 1 year
Number and length of breaks the participants took from their cognitive work. The values represent the mean number of breaks subjects took during their working time, higher numbers represent more breaks. As well the mean time of breaks in minutes where higher number represents longer time of break.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 31111829Korn L, Hassan K, Fainshtein N, Yusov N, Davidovitch N. Non-Medical Use of Prescription Stimulants for Treatment of Attention Disorders by University Students: Characteristics and Associations. Med Sci Monit. 2019 May 21;25:3778-3787. doi: 10.12659/MSM.913973.
- Individual participant dataSharing planned: Yes. The result of the study will be analyzed. A paper will be submitted to an international journal with study description including methods, examination protocol results.
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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.
Liat Korn, PhD principal investigator
Ariel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Treadmill workstation and Methylphenidate in people with Attention Deficit Disorder, run by Ariel University 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 5 inclusion and 2 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 31 Mar 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Liat Korn, PhD (972 50 9099201, Liatk@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop performance (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05243186, which also lists 1 linked publication.
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 31 Mar 2022.