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Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

Primary Purpose

Attention Deficit Disorder

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Treadmill workstation
Methylphenidate
Sponsored by
Ariel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit Disorder focused on measuring Attention Deficit Disorder, Cognitive performance, Treadmill

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ariel UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

MPH walking

MPH sitting

No MPH walking

No MPH sitting

Arm Description

The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation

The participants will be instructed to work while taking Methylphenidate and sitting at a desk

The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation

The participants will be instructed to work without taking Methylphenidate while sitting at a desk

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 23, 2022
Last Updated
March 16, 2022
Sponsor
Ariel University
Collaborators
Maccabi Healthcare Services, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT05243186
Brief Title
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
Official Title
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ariel University
Collaborators
Maccabi Healthcare Services, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder
Keywords
Attention Deficit Disorder, Cognitive performance, Treadmill

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
All participants will participate in four different sessions of the study that will be randomly crossed over.
Masking
None (Open Label)
Masking Description
There are no masking in the study. All parties have all the information regard the conditions of the study.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MPH walking
Arm Type
Experimental
Arm Description
The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation
Arm Title
MPH sitting
Arm Type
Placebo Comparator
Arm Description
The participants will be instructed to work while taking Methylphenidate and sitting at a desk
Arm Title
No MPH walking
Arm Type
Placebo Comparator
Arm Description
The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation
Arm Title
No MPH sitting
Arm Type
Placebo Comparator
Arm Description
The participants will be instructed to work without taking Methylphenidate while sitting at a desk
Intervention Type
Device
Intervention Name(s)
Treadmill workstation
Other Intervention Name(s)
Walking on a treadmill workstation
Intervention Description
walking on a treadmill workstation next to desk with computer and screen
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
Using prescription drug
Primary Outcome Measure Information:
Title
Stroop performance
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Barhatt performance
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Breaks from work
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liat Korn, PhD
Phone
972 50 9099201
Email
Liatk@ariel.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Gideon Koren, Prof.
Phone
972 58 7194777
Email
gidiup_2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liat Korn, PhD
Organizational Affiliation
Ariel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ariel University
City
Ariel
ZIP/Postal Code
40700
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liat Korn, PhD
Phone
972 50 9099201
Email
Liatk@ariel.ac.il
First Name & Middle Initial & Last Name & Degree
Gideon Koren, MD
Phone
972 58 7194777
Email
gidiup_2000@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31111829
Citation
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.
Results Reference
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Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

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