Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 23, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 31, 2022
October 1, 2021
9 months
January 23, 2022
March 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (4)
MPH walking
EXPERIMENTALThe participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation
MPH sitting
PLACEBO COMPARATORThe participants will be instructed to work while taking Methylphenidate and sitting at a desk
No MPH walking
PLACEBO COMPARATORThe participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation
No MPH sitting
PLACEBO COMPARATORThe participants will be instructed to work without taking Methylphenidate while sitting at a desk
Interventions
walking on a treadmill workstation next to desk with computer and screen
Using prescription drug
Eligibility Criteria
You may qualify if:
- \* 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
You may not qualify if:
- Suffer from heart disease or chronic respiratory illness
- Women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ariel Universitylead
- Maccabi Healthcare Services, Israelcollaborator
Study Sites (1)
Ariel University
Ariel, 40700, Israel
Related 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.
PMID: 31111829BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liat Korn, PhD
Ariel University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- There are no masking in the study. All parties have all the information regard the conditions of the study.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2022
First Posted
February 16, 2022
Study Start
October 1, 2021
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
March 31, 2022
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year
- Access Criteria
- Pending collaborators decision.
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.