Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

Phase 2

• Conditions: Attention Deficit Disorder
• Interventions: Device: Treadmill workstation; Drug: Methylphenidate

• Registration Number: NCT05243186
• Lead Sponsor: Ariel University

Brief 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.

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 Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-01
• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-16
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-07
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Suffer from heart disease or chronic respiratory illness
• Women who are pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MPH walking	Treadmill workstation	The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation
No MPH walking	Treadmill workstation	The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation
No MPH sitting	Treadmill workstation	The participants will be instructed to work without taking Methylphenidate while sitting at a desk
MPH walking	Methylphenidate	The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation
MPH sitting	Methylphenidate	The participants will be instructed to work while taking Methylphenidate and sitting at a desk
No MPH sitting	Methylphenidate	The participants will be instructed to work without taking Methylphenidate while sitting at a desk

Primary Outcome Measures

Name	Time	Method
Stroop performance	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	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	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.

Trial Locations

Locations (1)

Ariel University; 🇮🇱 Ariel, Israel