Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

March 16, 2022 updated by: Ariel University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPH walking
The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation
Device: Treadmill workstation
walking on a treadmill workstation next to desk with computer and screen
Other Names:
  • Walking on a treadmill workstation
Drug: Methylphenidate
Using prescription drug
Other Names:
  • Ritalin
Placebo Comparator: MPH sitting
The participants will be instructed to work while taking Methylphenidate and sitting at a desk
Drug: Methylphenidate
Using prescription drug
Other Names:
  • Ritalin
Placebo Comparator: No MPH walking
The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation
Device: Treadmill workstation
walking on a treadmill workstation next to desk with computer and screen
Other Names:
  • Walking on a treadmill workstation
Placebo Comparator: No MPH sitting
The participants will be instructed to work without taking Methylphenidate while sitting at a desk
Device: Treadmill workstation
walking on a treadmill workstation next to desk with computer and screen
Other Names:
  • Walking on a treadmill workstation
Drug: Methylphenidate
Using prescription drug
Other Names:
  • Ritalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ariel University

Collaborators

Maccabi Healthcare Services, Israel

Investigators

  • Principal Investigator: Liat Korn, PhD, Ariel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

February 15, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ArielUni

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

IPD Sharing Time Frame

One year

IPD Sharing Access Criteria

Pending collaborators decision.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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