Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

Attention Deficit Disorder Clinical Trial

Official title:

Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243186
• Other study ID #: ArielUni
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2021
• Est. completion date: October 2022

Study information

• Verified date: October 2021
• Source: Ariel University
• Contact: Liat Korn, PhD
• Phone: 972 50 9099201
• Email: Liatk[@]ariel.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Suffer from heart disease or chronic respiratory illness

• Women who are pregnant

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Cognition Disorders
• Disease

Intervention

Device:
• Treadmill workstation
walking on a treadmill workstation next to desk with computer and screen

Drug:
• Methylphenidate
Using prescription drug

Locations

Country	Name	City	State
Israel	Ariel University	Ariel

Sponsors (2)

Lead Sponsor	Collaborator
Ariel University	Maccabi Healthcare Services, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.	Through study completion, an average of 1 year