Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

Sponsor
Ariel University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05243186
Collaborator
Maccabi Healthcare Services, Israel (Other)
30
1
4
12
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
All participants will participate in four different sessions of the study that will be randomly crossed over.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.
Primary Purpose:
Other
Official Title:
Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ariel University Ariel Israel 40700

    Sponsors and Collaborators

    • Ariel University
    • Maccabi Healthcare Services, Israel

    Investigators

    • Principal Investigator: Liat Korn, PhD, Ariel University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ariel University
    ClinicalTrials.gov Identifier:
    NCT05243186
    Other Study ID Numbers:
    • ArielUni
    First Posted:
    Feb 16, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ariel University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022