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| Name | Class |
|---|---|
| Maccabi Healthcare Services, Israel | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPH walking | Experimental | The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation |
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| MPH sitting | Placebo Comparator | The participants will be instructed to work while taking Methylphenidate and sitting at a desk |
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| No MPH walking | Placebo Comparator | The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation |
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| No MPH sitting | Placebo Comparator | The participants will be instructed to work without taking Methylphenidate while sitting at a desk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill workstation | Device | walking on a treadmill workstation next to desk with computer and screen |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
* Insured by Maccabi Health Services
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liat Korn, PhD | Contact | 972 50 9099201 | Liatk@ariel.ac.il | |
| Gideon Koren, Prof. | Contact | 972 58 7194777 | gidiup_2000@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Liat Korn, PhD | Ariel University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ariel University | Recruiting | Ariel | 40700 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31111829 | Background | 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. |
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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.
One year
Pending collaborators decision.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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All participants will participate in four different sessions of the study that will be randomly crossed over.
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There are no masking in the study. All parties have all the information regard the conditions of the study.
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| Methylphenidate | Drug | Using prescription drug |
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| Through study completion, an average of 1 year |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |